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HIV/AIDS clinical trials at UC Health
147 in progress, 78 open to new patients

  • A Prospective, Longitudinal Study of Endothelial Function in HIV/HCV Coinfected Subjects

    open to eligible people ages 18 years and up

    The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Participants will undergo non-invasive assessment of cardiovascular disease risk through measurements of endothelial function and blood biomarkers at baseline and 1 year (or 4 weeks and 24 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).

    at UCLA

  • A Randomized Trial to Prevent HIV Among Gay Couples

    open to eligible males ages 18 years and up

    The proposed study is a randomized controlled intervention to reduce sexual risk for HIV among HIV-negative concordant and HIV discordant gay couples. There are three arms of the study: 1) the in-person experimental condition, PRIDE, 2) the online adaptation of the experimental condition, ePRIDE, and 3) the time- and attention-matched in-person control condition, Men's Health. Participants (N = 300 couples) will be randomized equally into one of the three study conditions and assessed via surveys at baseline and at 3-, 6- and 9-months after completion of the intervention sessions.

    at UCSF

  • A Study of Virological Suppression (controlling a viral infection) for HIV-Positive Patients

    “The purpose of this study is to better understand what the best treatment method is to help HIV patients become undetectable.”

    open to eligible people ages 18 years and up

    This study will look at virologically suppression of patients with HIV who receive pharmacist or case management care.

    at UC Davis

  • Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)

    open to eligible people ages 18 years and up

    This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.

    at UCLA UCSD

  • Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite

    open to eligible people ages 18 years and up

    This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition to adulthood.

    at UCLA

  • An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) Injection in Kaposi Sarcoma (KS)

    open to eligible people ages 18 years and up

    To determine the safety of escalating doses of Tc 99m tilmanocept in HIV (human immunodeficiency virus) subjects with confirmed KS.

    at UCSF

  • Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men

    open to eligible males ages 18 years and up

    This clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. This study may help doctors develop better screening for high-grade anal dysplasia in MSM in order to identify those who need to return for additional screening and treatment.

    at UCLA

  • Biomarkers to Predict Time to Plasma HIV RNA Rebound

    open to eligible people ages 18-70

    The purpose of this study is to collect information about what happens when people pause, or temporarily stop taking, ART, and to collect blood samples from these people at frequent intervals. We will also study the safety of pausing ART under close observation.

    at UCLA UCSD UCSF

  • Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma

    open to eligible people ages 18 years and up

    This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin together with combination chemotherapy may kill more cancer cells.

    at UCSD UCLA UC Davis

  • Cabozantinib-S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus

    open to eligible people ages 18 years and up

    This phase I trial studies the side effects and best dose of cabozantinib-s-malate in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment and human immunodeficiency virus. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

    at UCLA UCSD

  • CCTG 603: Randomized Controlled Trial of iTAB Plus Motivational Interviewing for PrEP Adherence in Transgender Individuals (The iM-PrEPT Study)

    open to eligible people ages 18 years and up

    CCTG 603 is an open-label, two-arm, randomized (1:1) clinical demonstration project to determine if brief Motivational Interviewing (MI-B) added to a text-message based adherence intervention (iTAB) improves adherence to PrEP among transgender persons.

    at UCLA UCSD

  • Clinical Factors and Gene Expression Analysis for Prognosis in Tissue Samples From Patients With AIDS-Related Primary Effusion Lymphoma

    open to eligible people ages 18 years and up

    This research trial studies clinical factors and gene expression analysis for prognosis in tissue samples from patients with acquired immune deficiency syndrome (AIDS)-related primary effusion lymphoma. Gathering health information over time and studying samples of tissue from patients in the laboratory may help doctors learn about the prognosis of patients with AIDS-related primary effusion lymphoma.

    at UCSD UCLA

  • Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies

    open to eligible people ages 18 years and up

    RATIONALE: Collecting and studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

    PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related malignancies.

    at UCSD UCLA

  • Collection of Blood for Multiple Collaborative Studies

    open to eligible people ages 18 years and up

    This study seeks to confidentially collect blood from HIV-positive individuals and HIV-negative controls to provide basic scientists with specimens for collaborative studies.

    at UCSF

  • Computerized Substance Use and Depression Screening and Behavioral Treatment in HIV Primary Care

    open to all eligible people

    Substance use disorders (SUDs) and depression in HIV-infected patients result in poor HIV outcomes, yet are often unrecognized and untreated. To address these problems, this study examines the implementation and effectiveness of a clinical intervention consisting of self-administered tablet-based SUD and depression screening at routine HIV primary care clinic visits, followed by evidence-based treatments for SUD and depression delivered by a behavioral health specialist. If successful, this study has potential to reduce SUD- and depression-related problems and reduce HIV treatment disparities for patients with these comorbidities.

    at UCSF

  • Consent for Use of Stored Patient Specimens for Future Testing

    open to all eligible people

    The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic testing.

    at UCLA UCSD UCSF

  • Development of a Couple-Based Mobile Health Intervention for Enhancing HIV Care Engagement Outcomes (N'Gage)

    open to eligible males

    HIV/AIDS among Black men is a US public health crisis, emphasizing the urgency for increased research focus and intervention development. The overall objective of this application is to achieve a better understanding of the role that dyadic factors play in individual-level HIV care engagement outcomes among HIV-positive Black men in romantic relationships. The end goal is the development of an intervention that employs innovative mobile technology to target partnership dynamics that optimize outcomes in the HIV care continuum.

    at UCSF

  • Digital Health Feedback System (DHFS) for Longitudinal Monitoring of ARVs Used in HIV Pre-exposure Prophylaxis (PrEP)

    open to eligible people ages 18 years and up

    This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their Pre-Exposure Prophylaxis (PrEP) medication for HIV prevention. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their PrEP medication. The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to people taking PrEP; that patients will persist with its use; and that the system provides valid, accurate measures of adherence.

    at UCSD

  • Duo Partnership Adherence Commitment Therapy

    open to eligible males ages 18 years and up

    This is a randomized controlled trial of a new behavioral intervention designed to improve engagement in HIV care for same-sex male couples. Investigators will compare the HIV viral load outcomes of couples randomized to a couples-based adherence intervention (DuoPACT) or to an individual adherence intervention (LifeSteps).

    at UCSF

  • Early ART to Limit Infection and Establishment of Reservoir

    open to eligible people ages 18 years and up

    The study is being done to: - start ART early in those recently or acutely infected with HIV-1 - see how starting ART as soon as the infection is found affects the amount of HIV-1 in blood and how well the body fights the HIV-1 infection - look at the amount of HIV-1 DNA (genetic material for HIV-1) seen in CD4+ T-cells (infection-fighting cells in blood) after 48 weeks of ART - see how early treatment for HIV affects the numbers of HIV-1 infection fighting cells (CD4+ and CD8+ T-cells) in blood

    at UCLA UCSD

  • Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain

    open to eligible people ages 18 years and up

    Acute cannabis administration is reported to alleviate HIV neuropathic pain (HIV-NP), but there is limited knowledge about the effects of cannabis constituents (delta-9 tetrahydrocannabinol/THC and cannabidiol/CBD), the consequences of long-term cannabis use, and the impact of cannabis on endocannabinoid (EC) function in people living with HIV- NP. Our objective is to address these three fundamental gaps in our knowledge by: 1) examining the acute effects of various CBD/THC products on HIV-NP, 2) utilizing a mHealth text messaging protocol, Individual Monitoring of Pain and Cannabis Taken (IMPACT) to monitor daily real-world cannabis use and changes in pain; and 3) studying the relationship between cannabinoids, EC biomarkers, and chronic neuropathic pain

    at UCSD

  • Effect of PCSK9 Inhibition on Cardiovascular Risk in Treated HIV Infection (EPIC-HIV Study)

    open to eligible people ages 40 years and up

    Atherosclerosis in the setting of HIV infection is distinct and includes increased vascular inflammation, worsened endothelial function, and a predominance of non-calcified plaque. These outcomes can be assessed using specialized noninvasive imaging which strongly predict future CV events in the general population. PCSK9 has emerged as an important pharmacologic target for cholesterol lowering in the general population and recent studies among individuals without HIV have shown that PCSK9 inhibitor therapy is safely tolerated and significantly reduces major CV events in the general population. The investigators will perform a clinical trial of PCSK9 inhibition in the setting of HIV infection. This will be a randomized, placebo-controlled study to evaluate the effects of PCSK9 inhibition on vascular inflammation, endothelial function, and non-calcified plaque using a PCSK9 inhibitor called alirocumab. This study will recruit 140 treated individuals with HIV who are aged 40 and older, with known CVD or risk factors for CVD and who have evidence of vascular inflammation at baseline. The primary and secondary objective of this study is to determine whether PCSK9 inhibition can improve arterial inflammation as assessed by FDG-PET/CT and endothelial function as assessed by flow mediated vasodilation. The investigators will correlate changes in arterial inflammation and endothelial function with lipids and markers of inflammation and immune activation. The tertiary objective is to perform a pilot evaluation of the impact of PCSK9 inhibition on non-calcified plaque as measured by coronary CT angiography. Non-calcified plaque measurements will be correlated with changes in lipid parameters and markers of inflammation and immune activation.

    at UCSF

  • Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care

    open to eligible people ages 18 years and up

    Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL), prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits communities by reducing transmission to others. Mere availability of ART and care, however, is insufficient; the benefits of ART depend upon HIV+ persons' continuous visits to the health care provider, regular monitoring and regular delivery of medications, - known as retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons, especially low-income minorities are out of care. Innovative interventions are therefore urgently needed to maximize engagement and retention in HIV care, self-reported adherence, as well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study will assess outcomes of the following interventions in comparison to usual care: 1) contingency management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that integrates both CM and PN (CA) which the investigators hypothesize to be most effective in improving HIV clinical outcomes.

    at UCLA

  • Efficacy of ART to Interrupt HIV Transmission Networks

    open to eligible people ages 18 years and up

    The investigators are conducting a study to learn more about the spread of HIV infection within different geographic regions and populations in San Diego County, with the goal of demonstrating that early use of HIV treatment can reduce the number of new infections in our community. At the study visits, participants will be examined by the study staff and asked to donate some blood. Participants will also be asked several questions about themselves, their background, behaviors, health, and the general geographic area in which they live. By collecting information about antiretroviral treatment choices that are made by study participants, the investigators will be better able to measure how effectively HIV treatment can interrupt (i.e., block) the spread of HIV. All of the information gathered at the study visits will be de-identified and analyzed. Study staff will use the information to better understand in which groups of people, and in what areas of San Diego, HIV is spreading most quickly. This information will be used to determine how well Antiretroviral Therapy (HIV treatment) by certain individuals can control the spread of HIV within the population.

    at UCSD

  • Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen

    open to eligible people ages 1 month to 17 years

    This study will evaluate the pharmacokinetics (PK), safety, and efficacy of emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected children and adolescents virologically suppressed (defined as having < 50 copies/mL of HIV-1 RNA for a period of at least 6 months) while on a stable 2-nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) containing regimen.

    at UCLA

  • Engaging Seronegative Youth to Optimize HIV Prevention Continuum

    open to eligible people ages 12-24

    The focus of this study (Engaging Seronegative Youth to Optimize HIV Prevention Continuum) - will be to stop HIV-related risk acts and to encourage youth at high risk for HIV to adopt antiretroviral medications as treatment and prevention (either pre exposure prophylaxis (PrEP) or post exposure prophylaxis) among gay, bisexual and transgender and/or homeless youth with contact with the criminal justice system in the HIV epicenters of Los Angeles and New Orleans. A cohort of 1500 youth at the highest risk of seroconverting over 24 months will be identified. The goal will be to optimize the HIV Prevention Continuum over 24 months. The proposed randomized controlled trial (RCT) aims to compare youth outcomes when randomized to one of four automated and person-mediated social media delivered intervention conditions: 1) Automated Messaging and Monitoring Intervention (AMMI) only (n=900) consisting of daily motivational, instructional, and referral text-messaging (SMS), and brief, weekly SMS monitoring surveys of outcomes; 2) Peer Support through social media plus AMMI (n=200) via private online discussion boards; 3) Coaching plus AMMI (n=200) to provide service linkages, eligibility support, appointment coordination and follow-up, communication with healthcare providers, and brief motivational and strengths-based counseling for linkage and retention to prevention, mental health, and substance abuse services; and, 4) Coaching plus Peer Support and AMMI (n=200).

    at UCLA UCSF

  • Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in HIV-Infected Infants Receiving Combination Antiretroviral Therapy

    open to all eligible people

    The purpose of this study is to evaluate the safety and antiviral activity of VRC01 in HIV-1-infected infants beginning combination antiretroviral therapy (cART).

    at UCLA

  • Evaluating the Safety and Pharmacokinetics of Maraviroc in HIV-1-Exposed Infants at Risk of Acquiring HIV-1 Infection

    open to all eligible people

    This study will evaluate the safety, tolerability, and pharmacokinetics of maraviroc in infants at risk for mother-to-child HIV transmission and determine an appropriate dose of maraviroc during the first 6 weeks of life.

    at UCSD

  • Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

    open to all eligible people

    The purpose of this study is to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.

    at UCLA UCSD

  • Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults

    open to eligible people ages 40-75

    The study is funded by the National Heart, Lung, and Blood Institute, with additional infrastructure support provided by the National Institute of Allergy and Infectious Diseases. People infected with HIV are at risk for cardiovascular disease (CVD). This study will evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who are on antiretroviral therapy (ART).

    at UCLA UCSD UCSF

  • Experimental medicine in Treating Patients With HIV-Associated Hodgkin Lymphoma

    open to eligible people ages 19 years and up

    This phase I trial studies the side effects and best dose of nivolumab when given with ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical Hodgkin lymphoma that has returned after a period of improvement or does not respond to treatment, or solid tumors that have spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may block tumor growth in different ways by targeting certain cells. Ipilimumab is an antibody that acts against a molecule called cytotoxic T-lymphocyte antigen 4 (CTLA-4). CTLA-4 controls a part of your immune system by shutting it down. Nivolumab is a type of antibody that is specific for human programmed cell death 1 (PD-1), a protein that is responsible for destruction of immune cells. Giving ipilimumab with nivolumab may work better in treating patients with HIV associated classical Hodgkin lymphoma or solid tumors.

    at UCLA UCSF UCSD UC Davis

  • Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant

    “Study looking at stem cell gene therapy to treat patients with HIV and lymphoma”

    open to eligible people ages 19 years and up

    This phase I/II trial studies the side effects and best dose of gene therapy in treating patients with human immunodeficiency virus (HIV)-related lymphoma that did not respond to therapy or came back after an original response receiving stem cell transplant. In gene therapy, small stretches of deoxyribonucleic acid (DNA) called "anti-HIV genes" are introduced into the stem cells in the laboratory to make the gene therapy product used in this study. The type of anti-HIV genes and therapy in this study may make the patient's immune cells more resistant to HIV-1 and prevent new immune cells from getting infected with HIV-1.

    at UCSD UC Davis UCSF

  • HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients

    open to eligible people ages 18 years and up

    The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications.

    at UCSF UCLA UCSD

  • HOPE Social Media Intervention for HIV Testing and Studying Social Networks

    open to eligible males ages 18-89

    This study [HOPE: Harnessing Online Peer Education] seeks to determine the efficacy of using online social networks to scale peer community leader models to increase HIV prevention within African-American and Latino men who have sex with men. The peer community leader model, which teaches community popular opinion leaders about how to disseminate behavior changes messages throughout the community, has been proven to increase HIV prevention behaviors. Social networks such as Facebook.com may be a cost-effective platform for scaling these models. Primarily upper middle-class White populations used the Internet in its early years, however, Internet use within African-American and Latino households has recently increased dramatically, especially on online social networks such as Facebook.com. People using the Internet may be at the highest risk for contracting HIV and are using novel Internet approaches to find sex partners, such as through online social networks. This is the first study to examine the effectiveness of the HOPE social media intervention to increase HIV testing among at-risk groups in the United States.

    at UCLA

  • Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas

    open to eligible people ages 18 years and up

    This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse large B-cell lymphomas.

    at UCSF UCSD UCLA

  • Imaging Immune Activation in HIV by PET-MR

    open to eligible people ages 18 years and up

    This is a single center exploratory imaging study involving one intravenous microdose of [18F]F-AraG followed by whole-body positron emission tomography-magnetic resonance (PET-MR) imaging in HIV infected individuals to determine the anatomical distribution of the PET tracer. Participants will be enrolled if they were treated during early or late HIV infection. In addition, individuals not on antiretroviral therapy (ART) or with HIV-1 plasma RNA levels >5,000 copies/mL will be enrolled.

    at UCSF

  • Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection

    open to eligible people ages 18 years and up

    The purpose of this study is to identify and provide immediate antiretroviral therapy to a cohort of HIV-infected individuals with very early HIV infection (estimated date of infection within the last 90 days). The primary aim of the study is to evaluate whether initiation of dolutegravir plus emtricitabine/tenofovir during acute/early HIV infection leads to protection of CD4+ T cells and other immune cells in the peripheral blood and lymphoid tissue from infection.

    at UCSF

  • Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients

    open to eligible people ages 18 years and up

    Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant.

    at UCLA UCSF

  • Impact of DAA Uptake in Controlling HCV Epidemic and Modeling Interventions for HCV Elimination Among HIV-infected Persons in San Diego

    open to eligible people ages 18 years and up

    A retrospective and prospective study among people living with HIV (PLWH) that assesses hepatitis C (HCV) treatment uptake during periods before and after direct acting antivirals (DAA) introduction, and its impact on the HCV epidemic among PLWH.

    at UCSD

  • Impact of Hepatitis C Virus Therapy on Central Nervous System Outcomes

    open to eligible people ages 18 years and up

    This partially blinded placebo-controlled trial will determine the impact of curing Hepatitis C Virus (HCV) with an oral direct-acting antiviral (DAA), ledipasvir and sofosbuvir in a single pill, on central nervous system (CNS) outcomes in mono- or Human Immunodeficiency Virus (HIV) co-infected individuals.

    at UCSD

  • Improving Engagement in HIV Care for High-risk Women

    open to eligible males ages 18 years and up

    Transgender women (assigned 'male' at birth but who do not identify as male) are disproportionately impacted by HIV and have culturally unique barriers and facilitators to engagement in HIV care. Transgender women living with HIV (TWH) are less likely than others to take antiretroviral therapy (ART), and those who initiate ART have lower rates of ART adherence, lower self-efficacy for integrating ART into daily routines, and report fewer positive interactions with health care providers than non-transgender adults. As a result, TWH have an almost three-fold higher viral load than non-transgender adults in San Francisco; in Los Angeles, TWH are less likely to be virally suppressed than any other behavioral risk group. In formative work, the investigators have identified culturally-specific and modifiable barriers to HIV treatment engagement among TWH, including prioritization of transition-related health care (i.e. hormone therapy) at the expense of HIV treatment, avoidance of HIV care settings due to past negative health care experiences, misinformation about ART including potential drug interactions with hormones, intensified HIV stigma, low levels of social support, and poor coping skills. There are both individual and public health consequences to poor engagement in care among TWH stemming from high transmission risk factors, including substance abuse, high numbers of sex partners, engagement in sex work, and high rates of mental illness. These findings strongly suggest that TWH face unique challenges to engaging in and adhering to HIV treatment, and that the public health consequences for poor engagement in this population are of grave concern. Interventions to mitigate these barriers to engagement in care are critical in efforts to alter the pattern of HIV-related disparities that lead to disproportionately poor health outcomes for this highly vulnerable and marginalized population. The investigators are conducting a randomized controlled trial of a theory-driven, population-specific, piloted intervention to improve engagement in care for TWH. Grounded in the investigators' Models of Gender Affirmation and Health Care Empowerment, the proposed research is the first to systematically intervene on complex barriers to optimal engagement in HIV care for TWH. The investigators have developed and piloted the Healthy Divas intervention to optimize engagement in HIV care for TWH at elevated risk for treatment failure and consequential morbidity, mortality, and transmission of HIV.

    at UCSF

  • Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma

    open to eligible people ages 18 years and up

    There is no clear treatment for patients with limited cutaneous Kaposi sarcoma (KS). Radiation and injection of vinblastine both have side effects that may not be acceptable. Nivolumab has been used to treat more extensive KS when given intravenously. This is, to the investigators' knowledge, the first trial to see if nivolumab can be used as treatment in the form of an injection into KS lesion.

    at UCSF

  • iSTEP - an mHealth Physical Activity and Diet Intervention for Persons With HIV

    open to eligible people ages 18 years and up

    HIV is associated with a pattern of neurocognitive deficits, metabolic dysfunction, and an elevated risk for cardiovascular disease (CVD), phenomena that remain untreated despite the use of medications to control the disease. This proposal will examine the effect of a personalized, automated, interactive mobile phone text message intervention (iSTEP) designed to increase moderate physical activity (PA), decrease sedentary behavior (SB), and promote a healthy Mediterranean-style diet (MedDiet) in persons living with HIV (PLWH). The investigators propose that participants who receive the iSTEP intervention will increase the amount of physical activity, improve their diet, show a reduction in risk factors for CVD, and exhibit improved neurocognitive performance.

    at UCSD

  • Linkage of Transgender Individuals to PrEP

    open to eligible people ages 18 years and up

    CCTG 602 is a multisite demonstration project to evaluate the effectiveness of facilitated linkage to PrEP using a community-based transgender PrEP outreach worker (T-POWr) versus standard of care (SOC).

    at UCLA UCSD

  • Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System

    open to eligible people ages 17 years and up

    Introduction of antiretroviral therapy (ART) has transformed HIV-infection from a fatal to manageable disease but adherence to ART remains critical to optimize outcomes. Existing measures of ART adherence provide only inferred measures of actual drug intake and most offer no real-time notification capability. Directly observed therapy measures actual drug intake but is not practical. These limitations constrain research into medication adherence and more importantly, limit our ability to develop real-time interventions based on feasible, in vivo monitoring of adherence among HIV-infected people to facilitate medication-taking. The Proteus digital health feedback (PDHF) system, a pill ingestible sensor based adherence measuring and monitoring system developed by Proteus Digital Health, addresses these limitations. It involves use of an ingestible sensor, a tiny edible material that is over-encapsulated along with prescribed medication. The sensor is activated by ingestion and is sensed by a patch worn by the patient with an embedded monitor and sensor. The monitor sends a Bluetooth signal to a mobile device, which in turn sends an encrypted message to a central server, thus effecting real-time monitoring that a dose has been taken. The investigators propose to develop a data receiving hub and add to these components an automated text message that is sent to the patient when a dose is missed. The investigators will evaluate the feasibility, acceptability and sustainability of using the PDHF system; assess the accuracy of the PDHF system in measuring adherence to ART; and evaluate the efficacy of the PDHF system for monitoring and leveraging adherence to ART.

    at UCLA

  • Mindfulness Based Stress Reduction for Older Adults With HIV Associated Neurocognitive Disorders

    open to eligible people ages 55 years and up

    The purpose of this study is to determine the efficacy of Mindfulness Based Stress Reduction (MBSR) to alleviate stress, anxiety, and depressive symptoms, and improve attention among patients aged 60 or older who suffer from HIV-associated neurocognitive disorders (HAND) and have maximized treatment options.

    at UCSF

  • Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection

    open to eligible people ages 18 years and up

    This study is being done to see if a minimal monitoring approach is effective and safe when providing HCV treatment. The minimal monitoring approach will require fewer study visits and lab tests with no medication refills. This study is trying to see whether taking an HCV treatment with fewer clinic visits and laboratory tests can cure just as many people as the standard approach that uses more visits and laboratory tests. The results of this study will be compared with what has been observed in other studies using a standard approach.

    at UCLA UCSD UCSF

  • Obstructive Sleep Apnea Endotypes and Impact on Phenotypes of People Living With HIV

    open to eligible people ages 18-65

    The investigators seek to understand how the different underlying causes of OSA affect the way people living with HIV (PLWH) experience OSA. The investigators also want to understand how symptoms of obstructive sleep apnea improve with treatment, and if this too, is affected by the underlying cause of OSA in that individual

    at UCSD

  • Oxytocin HIV Meth Study

    open to eligible males ages 18-65

    The purpose of this pilot study is to determine the tolerability, feasibility, and preliminary effectiveness of intranasal oxytocin administration prior to motivational enhancement group therapy sessions on laboratory-based measures of addiction, social connectedness, and stress responsivity in methamphetamine(meth)-using men who have sex with men (MSM). The investigators propose a randomized, double-blind, study of intranasal oxytocin versus placebo 40 IU prior to each of six Motivational Interviewing Group Therapy (MIGT) sessions in 28 mixed HIV sero-status MSM initiating treatment for amphetamine use disorder.

    at UCSF

  • Pembrolizumab in Treating Patients With HIV and Relapsed, Refractory, or Disseminated Malignant Neoplasms

    open to eligible people ages 18 years and up

    This phase I trial studies the side effects of pembrolizumab in treating patients with human immunodeficiency virus (HIV) and malignant neoplasms that have come back (relapsed), do not respond to treatment (refractory), or have distributed over a large area in the body (disseminated). Monoclonal antibodies, such as pembrolizumab, may block tumor or cancer growth in different ways by targeting certain cells. It may also help the immune system kill cancer cells.

    at UCSF

  • Perturbing of HIV Reservoir With Immune Stimulation

    open to eligible people ages 18-65

    The purpose of this study is to determine the impact of Pneumococcus and Influenza vaccines on the HIV transcriptional activity in individuals who are virologically suppressed for at least 48 weeks on similar ART. The proposed study is a randomized double-blinded control trial conducted over 28 weeks. Randomized interventions will be injections of Influenza vaccine, Pneumococcal vaccine, and Placebo. Each participant will receive each injection but in a randomized order.

    at UCSD

  • PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)

    open to eligible people ages 18 years and up

    This is a single center exploratory imaging study involving one intravenous microdose of 89Zr-DFO-VRC01 followed by whole-body PET-MR imaging in HIV infected individuals and healthy volunteers. Imaging data will be obtained from up to four static PE-MR images in order to determine dosimetry and temporal tissue uptake/tissue distribution of 89Zr-DFO-VRC01. This is not a treatment study of the biological activity of 89Zr-DFO-VRC01 to impact HIV persistence.

    at UCSF

  • Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

    open to eligible females

    The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.

    at UCLA UCSD UCSF

  • Pharmacokinetics Distribution of Raltegravir by PET/MR

    open to eligible people ages 18 years and up

    This is a single-center drug distribution and pharmacokinetic study of a single microdose of 18F-raltegravir given to 10 HIV-infected subjects who are either taking or not taking a raltegravir-containing ART regimen. After administration of IV 18F-raltegravir, subjects will undergo PET/MRI in order to determine the distribution of radiolabeled drug through the lymphoreticular system and other tissues throughout the entire body.

    at UCSF

  • Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons

    open to eligible people ages 40 years and up

    The aim of this study is to test whether tesamorelin, in combination with a text-messaging application to help with motivation and adherence, will significantly improve memory and thinking in HIV.

    at UCSD

  • Platelet Function on Abacavir and Tenofovir

    open to eligible people ages 18 years and up

    This is a small observational study aimed at observing differences in platelet function in HIV patients on abacavir versus tenofovir based anti-HIV drugs. There is some correlation between platelet activation and cardiovascular disease- this study will act as a pilot to see if platelet activation among abacavir users may explain the correlation between abacavir and cardiovascular disease in HIV positive patients. This study will enroll 44 participants total; 22 on abacavir-based treatment, 22 on tenofovir-based treatment. There is only one study visit which includes a blood draw, physical assessment, and review of medical history.

    at UCLA

  • Pre-exposure Prophylaxis (PrEP) Adherence Enhancement Guided by iTAB and Drug Levels for Women

    open to eligible females ages 18 years and up

    The purpose of this study is to test a program that uses drug level monitoring, text messaging ("iTAB") and personalized counseling with HIV prevention services, including PrEP (medicine that can help prevent HIV infection when taken daily).

    at UCLA UCSD

  • Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection

    open to eligible people ages 12-24

    This is a strategic prospective cohort study which will measure the effects of early intensive antiretroviral therapy (ART) on the establishment and persistence of HIV-1 reservoirs and HIV-1-specific immunity in acutely /recently HIV infected youth aged 12 to 24 years as compared to newly diagnosed youth with established infection > 6 months. Participants with newly diagnosed acute /recent HIV-1 infection will be offered enrollment into the study with immediate initiation of ART which is the current standard of care.

    at UCLA

  • Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)

    open to eligible people ages 18-80

    Increased comorbidities such as cardiovascular disease (CVD), are emerging problems in HIV infection but the mechanisms are unclear. Understanding how antiretrovirals can minimize morbidity in treated HIV infection is a research priority. Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) are included in all HIV treatment regimens. Tenofovir (TFV) disoproxil fumarate (TDF) has been associated with an increased risk of nephrotoxicity and bone disease compared with other NRTIs. Tenofovir alafenamide (TAF) is an oral prodrug of TFV, but is more stable in plasma as compared with TDF and lower plasma levels of TFV are thought to lead to the favorable safety profile of TAF. Mitochondrial dysfunction has a key role in HIV pathogenesis and may be the common denominator that drives pathogenesis of several comorbidities. Despite the better safety profile of newer (such as TDF) compared to older NRTIs, there are concerns for the potential for longer term toxicity of NRTIs since the exact cellular effects of NRTIs remain unclear. It is unknown whether a four-fold increase in intracellular drug levels seen in peripheral blood mononuclear cells (PBMCs) with TAF may increase toxicity in mitochondria. Better understanding of these effects could provide insights into mechanisms of HIV pathogenesis and selection of NRTIs that improve morbidity in chronic HIV infection. Hypothesis: Despite higher intracellular levels, TAF has minimal mitochondrial toxicity compared to TDF in vivo. This research will explore the relative mitochondrial toxicity of newer NRTIs (TAF, TDF) as a possible mechanism for differential NTRI-related toxicities. These data will allow selection of NRTIs that may improve morbidity in chronic treated HIV infection. Towards this aim, the investigators will use a robust experimental approach to study NRTI-related mitochondrial dysfunction using novel methods, human cell lines and PBMC. Our specific aims are: Aim 1: To evaluate the relative in vitro effects of TAF and TDF compared to an older NRTI (ddC) on 5 independent measures of mitochondrial function in the human cell line HepG2 and PBMC. Aim 2: To explore in vivo whether there is increased mitochondrial dysfunction with the use of TAF vs. TDF in chronic treated HIV infection. The investigators anticipate that the proposed experimental approach will set the basis for future large scale studies to directly compare subtle potential mitochondrial toxicities of newer NRTIs in large HIV cohorts.

    at UCLA

  • Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men

    open to eligible people ages 18 years and up

    This study will evaluate the safety and efficacy of the injectable drug cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).

    at UCLA UCSF

  • Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents

    open to eligible people ages up to 17 years

    Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class. This study will test the safety of and immune response to DTG in HIV-1 infected infants, children, and adolescents.

    at UCLA UCSD UCSF

  • Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 Infected Patients

    open to eligible people ages 18-75

    The purpose of the study is to evaluate the safety and feasibility of administering SB-728mR-HSPC after conditioning with busulfan.

    at UCLA

  • Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM

    open to eligible males ages 18-70

    This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of naltrexone 50mg, to be taken in anticipation of heavy drinking. Ethnically and racially diverse participants will be recruited using Respondent Driven Sampling as well as active field recruitment. MSM will be seen weekly for alcohol-metabolite urine testing, study drug dispensing, and brief counseling for alcohol use. Safety assessments and behavioral surveys will be completed monthly.

    at UCSF

  • SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era

    open to eligible people ages 18 years and up

    SCOPE is an observational, prospective study of HIV-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data. SCOPE specimens will be used to examine multiple questions involving virologic, immunologic, and host factors involved in HIV-1 infection, progression, non-progression, response to treatment, control of HIV-1 virus, and evolution of drug resistance.

    at UCSF

  • Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant

    open to eligible people ages 18 years and up

    Retrospective/Prospective, open-label study using sofosbuvir based DAA therapy to treat HIV/HCV coinfected pre or post liver transplant participants

    at UCSF

  • Specimen Repository for HIV Immunopathogenesis

    open to eligible people ages 18 years and up

    Specimen Repository for HIV Immunopathogenesis Studies

    at UCLA

  • Stepped Care for Youth Living With HIV

    open to eligible people ages 12-24

    Optimizing the HIV Treatment Continuum with a Stepped Care Model for Youth Living with HIV (YLH) aims to achieve viral suppression among YLH. A cohort of 220 YLH will be identified in Los Angeles, CA and New Orleans, LA and recruited into a randomized controlled trial (RCT) with reassessments every 4 months over a 24 month follow-up period. The goal is to optimize the HIV Treatment Continuum over 24 months. YLH will be randomized into one of two study conditions: 1) Enhanced Standard Care Condition (n=110); or 2) Stepped Care (n=110). The Enhanced Standard Care condition will consist of an Automated Messaging and Monitoring Intervention (AMMI) with daily motivational, instructional and referral text messaging, and a brief weekly monitoring survey. The Stepped Care Condition will consist of three levels. Level 1 is the Enhanced Standard Care Condition. Level 2 is the Enhanced Standard Care Condition plus peer support using social media. Level 3 is the Enhanced Standard Care Condition and peer support plus coaching, which will be delivered primarily through electronic means (e.g., social media, text messaging, email, phone). All participants in the Stepped Care Condition begin at Level 1 but if they fail to have a suppressed viral load at any four-month assessment point, their intervention level will increase by one step until reaching Level 3.

    at UCLA

  • Supporting Treatment Adherence Readiness Through Training (START)

    open to eligible people ages 18 years and up

    Multi-site, randomized controlled trial of the Adherence Readiness Program (ARP) adherence intervention for HIV clients starting or restarting antiretroviral therapy (ART) for the purpose of achieving and sustaining optimal levels of ART adherence and virologic suppression. Eligible participants will be randomized to receive either the ARP intervention or usual care (no intervention) and followed for 24 months.

    at UCLA

  • Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV Infection

    open to all eligible people

    This phase II trial studies surgery in treating patients with anal canal or perianal cancer that is small and has not spread deeply into the tissues and human immunodeficiency virus (HIV) infection. Local surgery may be a safer treatment with fewer side effects than bigger surgery or radiation and chemotherapy.

    at UCSF

  • The Pathogenesis of OSA in People Living With HIV

    open to eligible people ages 40-79

    The purpose of this study is to help us understand how HIV and/or Anti-Retroviral Therapy (ART) may predispose individuals to Obstructive Sleep Apnea (OSA). The traditional risk factors for OSA are weight and age. However, people living with HIV on ART seem to have OSA even when they are thin and young. The study involves a detailed physiological sleep study and an MRI of the head and neck to understand the underlying cause of OSA in those with and without HIV.

    at UCSD

  • The Use of Leukapheresis to Support HIV Pathogenesis Studies

    open to eligible people ages 18 years and up

    Despite the dramatic improvements that have resulted from combination antiretroviral treatment, long-term efficacy, toxicity, cost, and the requirements for life-long adherence remain as formidable challenges. Also, there is emerging consensus that persistent HIV-associated disease occurs during long-term highly active antiretroviral therapy (HAART). This disease may be due to either direct drug-toxicity and/or persistent viral replication/production and/or persistent HIV-associated inflammation. Hence, strategies aimed at achieving complete viral eradication may be needed in order to fully restore health among HIV infected individuals. Even if complete eradication proves impossible—as most believe to be the case—a less rigorous but still desirable outcome might be achieving durable control of virus in the absence of therapy. That a "functional" cure is possible is well illustrated by those rare individuals who are able to durably control replication competent virus in the absence of therapy ("elite" controllers). A more complete understanding of the relationship between inflammation and viral persistence is necessary before more rationale studies of HIV eradication can be designed. Also, a well validated high through-put virologic assay needs to be developed that can estimate the size of the latent reservoir. Since the level of replication competent virus in long-term treated patients (and in elite controllers) is very small (< 1% of CD4 cells harbor HIV), large numbers of CD4+ T cells most be obtained from study participants in order to routinely isolate and quantify virus persistence.

    at UCSF

  • The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies

    open to eligible people ages 18-70

    HIV medicines have led to dramatic improvements in health. However, there remains a concern for potential drug toxicities, cost of drugs, and need for life-long treatment. In addition, research has found that health is not completely restored in HIV-infected patients, even if they have been taking effective HIV medicines for a long time. This may be due to direct drug-toxicity, continued replication of the virus, and/or inflammation of the body in response to the virus. Therefore, a more complete understanding of how HIV stays in the body is necessary. Recent research has shown that one of the places that HIV can stay in the body is in lymphatic tissues such as lymph nodes (even in patients who have been taking HIV medicines for a long time). In addition, the amount of damage to the lymphatic tissues can predict how the immune system (CD4+ T cell count) will respond to therapy. The investigators therefore propose a study in which lymph nodes from the groin area will be removed, with the goals of: 1) seeing how much HIV is in lymph nodes and 2) seeing how much damage has happened to the lymph node architecture.

    at UCSF

  • Therapeutic Vaccination in Treated HIV Disease

    open to eligible people ages 18-65

    The central premise of our program is that durable control of HIV in the absence of antiretroviral therapy ("remission") will require the generation of de novo potent and sustained HIV-specific CD8+ cell responses that target evolutionarily conserved epitopes. Our program is inspired by the recent success of VGX-3100 (Inovio), a DNA therapeutic vaccine for HPV that leads to histopathologic regression of pre-malignant lesions in people and is associated with a potent, sustained boost to HPV-specific CD8+ T cell populations. A closely related multi-clade gag/pol/env DNA vaccine administered with an IL-12 DNA plasmid (PENNVAX, Inovio) has been studied for HIV prevention and is known to be both safe and highly immunogenic. In a randomized placebo-controlled study we will compare the immunogenicity and anti-reservoir activities of gag/pol DNA versus gag/pol/env DNA (both administered with IL-12). We will determine for the first time in established HIV disease whether presence of env in a DNA vaccine blunts T cell responses to more conserved Gag-specific and Pol-specific epitopes. We will also determine if Env-specific responses (which will presumably be mediated by antibodies and ADCC) have a measurable effect on reservoir.

    at UCLA UCSF

  • Topical or Ablative Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Squamous Intraepithelial Lesions

    open to eligible people ages 35 years and up

    This randomized phase III trial compares topical or ablative treatment with active monitoring in preventing anal cancer in patients with human immunodeficiency virus (HIV) and high-grade squamous intraepithelial lesions (HSIL). Anal HSIL is tissue in the anal canal that has been damaged by infection with human papillomavirus (HPV) and is at risk for turning into anal cancer. It is not yet known if treating HSIL is more effective than active monitoring in preventing patients from developing anal cancer.

    at UCLA UCSF

  • Triggered Escalating Real-time Adherence (TERA) Intervention

    open to eligible people ages 13-24

    Youth Living with HIV (YLWH) often face unique challenges achieving high and sustained rates of adherence to their antiretroviral therapy (ART). Poor adherence can lead to unsuppressed virus, more advanced HIV disease and poorer health outcomes, eventually exhausting treatment options. To date however, there are few demonstrated interventions for youth failing first line therapy. This study will evaluate a novel intervention that uses remote coaching through video enabled counseling sessions, a 'smart' pill bottle that notifies an adherence coach when youth fail to open/close the device around dose time, and problem solving outreach by the coach when and as needed. This intensive 'boot camp' strategy is implemented for 12 weeks followed by observation through 48 weeks.

    at UCLA

  • Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission

    open to all eligible people

    The study will explore the effects of early intensive antiretroviral therapy (ART) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among HIV-infected infants.

    at UCLA UCSD

  • VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions

    open to eligible people ages 27 years and up

    This phase II trial studies the use of human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation in treating patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Electroporation helps pores in your body's cells take in the drug to strengthen your immune system's response. Giving VGX-3100 and electroporation together may work better in treating patients with high-grade anal lesions.

    at UCLA UCSF

  • Youth to Text or Telehealth for Engagement in HIV Care

    open to eligible people ages 18-29

    Youth To Text or Telehealth for Engagement in HIV Care (Y2TEC) is a randomized control pilot to assess the feasibility and acceptability of delivering a targeted problem-solving intervention to youth ages 18-29 living with HIV (YLWH) for improving HIV care engagement, mental health, and decreasing substance use. The intervention will be delivered to participants in two condition groups in remote telehealth sessions delivered via video-conference over 4 months. Participation in the study will last about 8 months. The investigators hypothesize that the Y2TEC intervention will be feasible and acceptable for YLWH, and will result in improved HIV clinical outcomes. If feasible and acceptable, it can be scaled up for a multi-site randomized clinical trial and ultimately offered in the clinical care of YLWH.

    at UCSF

  • A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine

    Sorry, currently not accepting new patients, but might later

    This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.

    at UCLA

  • Acceptance and Commitment Therapy for Aging People Living With HIV in Chronic Pain

    Sorry, not yet accepting patients

    Chronic pain impacts a large proportion of aging people living with HIV (aPLWH) and involves factors directly related to HIV (neurotoxicity) and psychosocial co-morbidities common in aPLWH (i.e. social isolation and loneliness). We hypothesize that novel interventions that acknowledge these psychosocial co-morbidities may improve the efficacy of chronic pain management and minimize the use of potentially dangerous medications. This grant proposes to adapt and pilot a pain psychotherapy approach using group acceptance and commitment therapy (ACT) in aPLWH with chronic pain.

    at UCSD

  • Adolescent Master Protocol

    Sorry, in progress, not accepting new patients

    The advances in treatment to prevent maternal HIV transmission to neonates have been groundbreaking. As a result, the number of new perinatally-infected children in the U.S. is now small. Subsequent improvements in the treatment of HIV-infected infants and children have been equally remarkable, ensuring that most previously infected American children have survived and are approaching adolescence. In addition, the number of HIV-infected adolescents worldwide is growing substantially in both resource-poor countries and in countries with increasing levels of health care. Therefore, there is a global cohort of children who have been living with HIV infection since birth who are aging into adolescence. Little is definitively known about the impact of HIV infection and its treatment on the maturation process in these children. AMP is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy on pre-adolescents and adolescents with perinatal HIV infection. Domains to be investigated include growth and sexual maturation, metabolic risk factors for cardiovascular disease, cardiac function, bone health, neurologic, neurodevelopment, language, hearing and behavioral function, and sexually transmitted infections (STI).

    at UCSD

  • Allogeneic Transplant in HIV Patients (BMT CTN 0903)

    Sorry, in progress, not accepting new patients

    The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT for patients with chemotherapy-sensitive hematological malignancies and coincident HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an indicator of the safety of transplant in this patient population. Correlative assays will focus upon the incidence of infectious complications in this patient population, the evolution of HIV infection and immunological reconstitution. Where feasible (and when this can be accomplished without compromise of either the donor quality or the timeliness of transplantation), an attempt will be made to identify donors who are homozygotes for the delta32 mutation for CCR5.

    at UCSF

  • An Adaptive Intervention for Depression Among Latinos Living With HIV.

    Sorry, not yet accepting patients

    This study will use a pilot sequential multiple assignment randomized trial (SMART) design to build an adaptive treatment strategy (ATS) for depression and engagement in HIV among Latinos living with HIV. The ATS is the sequencing of treatments, which are a behavioral activation therapy (BAT), a cognitive-behavioral therapy (CBT), and mobile health (mHealth) tool. The outcomes are to assess the feasibility of the SMART and ATS in the HIV care site and acceptability of the SMART and ATS to patients and clinic staff.

    at UCSF

  • Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV

    Sorry, in progress, not accepting new patients

    This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may help doctors find cancer cells early and plan better treatment for anal cancer. Completing multiple screening tests may help find the best method for detecting cell changes in the anus.

    at UCSF UCLA

  • Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.

    Sorry, in progress, not accepting new patients

    Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group). Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ between the two study groups over the 14-month follow-up period. Secondary Objectives: Component 1 (Long-term CTN 0049 follow-up): Using the CTN 0064 baseline data (self-report, medical record abstraction and biological data), the following CTN 0049 primary and secondary outcomes in participants who consented to the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of the CTN 0049 interventions: 1. HIV virological suppression 2. HIV primary care visit attendance 3. All-cause mortality

    at UCSF UCLA

  • Behavioral Therapy Development for Methamphetamine Abusers

    Sorry, currently not accepting new patients, but might later

    The purpose of this study is...to assess whether placing a substance abuse intervention for HIV+ methamphetamine users within an HIV medical care setting improves rates of follow-up on referral to treatment by primary care physicians; reduces drug use and sexual risk behaviors more than treatment-as-usual; and increases rates of adherence to HIV medication regimens.

    at UCLA

  • Black Men's Care, and Intervention to Re-Engage HIV+ Black Men in Care

    Sorry, not yet accepting patients

    The proposed study aims to develop an intervention that is strategic in that it will 1) be a focused on an approach that combines an in-person session with post-session, two-way text messaging to continue the intervention and reinforce the gains from the in-person session and 2) ultimately find HIV+ Black men who have sex with men who have left HIV care where they are likely to present (e.g., city and county health clinics, community-based organizations, emergency rooms).

    at UCSF

  • CCR5-modified CD4+ T Cells for HIV Infection

    Sorry, not yet accepting patients

    A Comparative Study of Autologous CD4+ T Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 versus ex vivo Expanded Unmodified Autologous CD4+ T Cells in Treated HIV-1 Infected Subjects

    at UCSF

  • CCTG 593: Testing and Linkage to Care

    Sorry, in progress, not accepting new patients

    This is a CCTG sponsored project to determine if those recently screened for HIV would accept assistance to be linked into appropriate health services. After receiving their HIV results, high-risk individuals who test negative will have an option to be linked into a study that offers them Pre-exposure Prophylaxis (PrEP), and individuals who test positive will have an option to be linked into care. If they accept, tested individuals will be in contact with an ALERT specialist that will help facilitate their linkage. The study's primary analysis will analyze how many HIV screened individuals accept the ALERT specialist assistance.

    at UCSD UCLA

  • CCTG 594: Engagement and Retention in Care for HIV+

    Sorry, in progress, not accepting new patients

    CCTG 594 is a controlled, unblinded, two-arm, randomized (1:1) clinical trial to evaluate the effectiveness of a clinic-based HIV ALERT specialist on improving endpoints of retention in care and maintenance of ART as compared to the current standard of care (SoC) in HIV primary care clinics.

    at UCSD UCLA

  • CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM

    Sorry, in progress, not accepting new patients

    CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration project to determine if the use of a text-message based adherence intervention (iTAB) improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.

    at UCSD UCLA

  • Changing Health Through Food Support (CHEFS) Program

    Sorry, in progress, not accepting new patients

    UCSF and Project Open Hand (POH), a community based organization in San Francisco which provides meals and groceries to chronically ill clients in the Bay Area, have partnered to conduct an initial randomized controlled trial (RCT) of the Changing Health through Food Support (CHEFS) pilot intervention implemented by POH. The intervention consists of providing comprehensive, medically-appropriate food support, individual nutritional counseling, and group-based nutritional education over 6 months to low-income clients who have been diagnosed with HIV in order to improve their viral load and health-related quality of life (primary outcomes) as well as depression, ART adherence, food security and diet quality (secondary outcomes). We will randomize 200 participants to the intervention (n=100) or control (n=100). Participants will be followed for 6 months. The investigators will assess outcomes at baseline and 6-month follow-up using a quantitative survey and blood draws. In addition, the investigators will conduct a qualitative study at follow-up in a subset of participants to understand perceived impacts, barriers and facilitators.

    at UCSF

  • Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Initial ARV Therapy

    Sorry, not yet accepting patients

    This study uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new Proteus Digital Health (PDH) technologies approved by the FDA, to collect information about patients taking their ARV medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which gives healthcare providers information about when patients have taken their ARV medications. The purpose of the study is to demonstrate that the DHFS is easy to use and acceptable to the HIV patient population; that patients will persist with its use; and that the system provides valid, accurate measures of adherence.

    at UCSD

  • Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures of systemic and vascular inflammation and endothelial function (all indicators of cardiovascular risk) in treated and suppressed HIV infected individuals This study will assess the safety and effects of canakinumab on endothelial function (assessed by flow-mediated vasodilation [FMD] of the brachial artery), vascular inflammation (assessed by FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk (high-sensitivity C-reactive protein [hsCRP]), interleukin-6 (IL-6), soluble CD163 (sCD163), D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir. 20 individuals will receive a single dose of 150mg canakinumab with follow-up for 18 weeks.

    at UCSF

  • Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients

    Sorry, currently not accepting new patients, but might later

    The purpose of this study is to look at the effectiveness of giving a new anti-HIV drug (AG1549) plus Viracept (nelfinavir) plus Combivir (a tablet containing zidovudine plus lamivudine) to HIV-infected patients who are not taking anti-HIV drugs.

    at UCSF UCLA

  • Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients

    Sorry, accepting new patients by invitation only

    A clinical observational study for patients with HIV co-infected with hepatitis C that investigates the levels of their health literacy, hepatitis C and HIV knowledge. Participants will complete a one-time assessment of these studied domains and categorized in three groups defined by their hepatitis C treatment referral status: not-referred, referred-attended, referred and no-show.

    at UCSD

  • Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

    Sorry, in progress, not accepting new patients

    The purpose of this study is to describe the epidemiology of pulmonary hypertension in individuals with HIV infection and to investigate its pathogenesis. We propose to conduct a prospective observational cohort study to determine the association between highly active antiretroviral therapy (HAART) and viral suppression in HIV-infected patients who have been identified to have pre-clinical pulmonary hypertension (Aim 1). In addition, we will investigate the mechanistic role of the HIV-1 Nef protein and HHV-8 infection in the development and progression of pulmonary hypertension in individuals with HIV (Aim 2). We will also investigate endothelial function in HIV-infected patients with pulmonary hypertension (Aim 3).

    at UCSF

  • Evaluating Long-Acting Antiretroviral Therapy in Non-Adherent HIV-Infected Individuals

    Sorry, not yet accepting patients

    The purpose of this study is to compare the efficacy, safety, and durability of two different strategies to treat participants with a history of sub-optimal adherence and control of their HIV infection: long-acting (LA) antiretroviral therapy (ART) and all-oral standard of care (SOC).

    at UCLA UCSD UCSF

  • Evaluating the Immunogenicity of the AIDSVAX B/E Vaccine and the MVA/HIV62B Vaccine in Healthy, HIV-1-Uninfected Adults Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.

    at UCSF

  • Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission

    Sorry, in progress, not accepting new patients

    HIV-infected pregnant women who begin taking antiretroviral (ARV) medications in the late stages of pregnancy need an effective medication regimen to reduce the risk of transmitting HIV to their children. This study will examine the virologic response, safety, and tolerability of two different ARV medication regimens in HIV-infected pregnant women who are between 20 and 36 weeks pregnant when they enter the study.

    at UCLA

  • Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men

    Sorry, in progress, not accepting new patients

    This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG) persons who have sex with men, in North America, South America, and Switzerland.

    at UCLA UCSF

  • Evaluating the Safety and Immune Response to Three Different DNA HIV Vaccines Administered With a MVA-CMDR Boost Vaccine in Healthy, HIV-Uninfected Adults

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the safety and immune response to three DNA vaccines and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in healthy, HIV-uninfected adults.

    at UCSF

  • Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants

    Sorry, in progress, not accepting new patients

    A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants

    at UCSF

  • Evaluating the Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA by Intramuscular Electroporation, in Healthy, HIV-Uninfected Adults

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.

    at UCSF

  • Evaluating the Safety and Immunogenicity of the IHV01 Protein Vaccine Primed and Co-Administered With HIV DNA CON-S Env Vaccine in Healthy, HIV-1-Uninfected Adults

    Sorry, not yet accepting patients

    The purpose of this study is to evaluate the safety and immunogenicity of the IHV01 protein vaccine primed and co-administered with HIV DNA CON-S env vaccine in healthy, HIV-1-uninfected adults.

    at UCSF

  • Evaluation of the Efficacy and Mechanisms of a Novel Intervention for Chronic Pain Tailored to People Living With HIV

    Sorry, not yet accepting patients

    Due to its prevalence and impact on quality of life and overall health, the National Academy of Medicine has called chronic pain a "public health crisis." Therefore, this proposal is relevant to public health because it seeks to improve chronic pain treatment in accordance with the approach recommended by the Department of Health and Human Services National Pain Strategy: to develop and test Pain Self-Management interventions tailored to the needs of vulnerable populations, particularly people living with HIV (PLWH). Chronic pain is an important and understudied comorbidity among PLWH; therefore, this proposal is responsive to the NIH's HIV Research Priorities, which identify comorbidities as a high priority research topic.

    at UCSD

  • Experimental Treatment With Doravirine and Lamivudine for People Infected With Human Immunodeficiency Virus Type 1 (HIV-1)

    “This research study will test a combination of drugs for the treatment of HIV-1 infection”

    Sorry, in progress, not accepting new patients

    This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of MK-8591 in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.

    at UC Davis

  • Facilitating HIV/AIDS and HIV Testing Literacy for Emergency Department Patients

    Sorry, accepting new patients by invitation only

    The Centers for Disease Control and Prevention (CDC) recommends that all patients should receive information about HIV/AIDS and HIV testing orally or in writing at every HIV testing encounter. However, for busy emergency departments (EDs), delivering information orally is a barrier to HIV testing, and written brochures likely are not useful for those with lower health or general literacy. Videos might be as or more efficacious than orally-delivered information in improving HIV/AIDS and HIV testing knowledge, particularly for those with lower health literacy skills. However, the resources required to show videos might limit their use in EDs. Pictorial brochures are a promising alternative, but are of unknown efficacy. The objectives of this study are to: (1) determine if HIV/AIDS and HIV testing information should be delivered by a video or pictorial brochure to emergency department (ED) patients to improve short-term (in the ED) knowledge about HIV/AIDS and HIV testing; (2) determine if longer-term retention (over 12 months) of HIV/AIDS and HIV testing knowledge is greater for those who watch a video or review a pictorial brochure; (3) determine if short-term improvement and longer-term retention in HIV/AIDS and HIV testing knowledge is better after watching a video or reviewing a pictorial brochure for those with lower health literacy, and if improvement and retention also varies by language spoken (English or Spanish); and (4) if willingness to be tested again in one year is greater for those who watch the video or review the pictorial brochure, and if this willingness also varies by health literacy level and language spoken.

    at UCLA

  • Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men

    Sorry, in progress, not accepting new patients

    This is a pilot study of a new 9-session individually delivered cognitive behavioral intervention targeting sexual minority stress. In this study, 40 HIV+ men sexual minority men will be recruited for the study then will be randomly assigned to either the new 9 session intervention or a writing task condition.

    at UCSF

  • HOPE in Action Trial of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients

    Sorry, not yet accepting patients

    The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications

    at UCSD UCSF

  • Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions

    Sorry, in progress, not accepting new patients

    This randomized phase III trial studies imiquimod or fluorouracil to see how well they work compared to observation in treating patients with high-grade anal squamous skin lesions who are human immunodeficiency virus (HIV)-positive. Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether imiquimod or fluorouracil is more effective than observation in treating high-grade anal squamous skin lesions.

    at UCLA UCSF

  • IMPAACT 2002: Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among US Youth With HIV

    Sorry, accepting new patients by invitation only

    IMPAACT 2002 is a prospective, multi-site, two-arm, cluster-randomized study to evaluate whether a health and wellness Cognitive Behavioral Therapy and Medication Management (COMB-R) intervention for depression demonstrates improved depression and medical outcomes for HIV-infected youth in the US compared to enhanced standard care (ESC).

    at UCLA UCSD

  • IMPAACT 2015 - Evaluation of the HIV-1 Reservoir in the Central Nervous System of Perinatally-Infected Youth and Young Adults With Cognitive Impairment

    Sorry, not currently recruiting here

    IMPAACT 2015 is a cross-sectional, exploratory study that will investigate the central nervous system (CNS) reservoir in perinatally HIV-infected adolescents and young adults on effective antiretroviral therapy with neurocognitive impairment. The study will assess the frequency with which HIV is detected in the cerebral spinal fluid (CSF) in this population and assess whether detectable HIV in the CSF correlates with markers of inflammation and neuronal injury. Findings from this study will advance understanding of the role of the CNS in HIV-1 persistence and its implications for future HIV-1 remission research.

    at UCLA UCSD

  • Improving the HIV PrEP Cascade Using an Intervention for Healthcare Providers

    Sorry, in progress, not accepting new patients

    The PrEP Optimization Intervention (PrEP-OI) aims to educate healthcare providers on PrEP and assist providers in the appropriate targeting of patients at increased risk for HIV acquisition, initiating PrEP when appropriate, and providing guidance on the ongoing monitoring and adherence counseling of patients on PrEP. The intervention includes a web-based panel management tool (called PrEP-Rx) and PrEP coordination (by a PrEP Coordinator). The PrEP-OI study will take place among participating primary care and specialty clinics across the San Francisco Department of Public Health.

    at UCSF

  • INcreasing Statin Prescribing in HIV Behavioral Economics REsearch

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    Cardiovascular disease is a major cause of morbidity and mortality among people living with HIV. Recent studies have demonstrated that patients with HIV experience a 50-100% increased risk of myocardial infarction and stroke compared to HIV-uninfected persons. They also face higher risks of stroke, sudden death, and heart failure. However, evidence-based statin therapy—which is safe in this population and highly effective at reducing cardiovascular risk—is under-prescribed. The investigators propose a multi-level intervention to increase evidence-based statin prescribing by addressing barriers at these levels. The implementation intervention includes two strategies: (1) tailored education at the leadership, provider, and patient levels, and (2) behavioral economics-informed feedback for providers.

    at UCLA

  • Inflammation, Viral Replication, and Atherosclerosis in Treated HIV Infection

    Sorry, in progress, not accepting new patients

    This is a longitudinal observational study of HIV-infected patients and HIV-negative control patients that is being conducted to learn more about immunologic factors, inflammation, and cardiovascular risk in patients with HIV infection or in patients with autoimmune disease. The investigators plan to obtain measurement of carotid artery intima media thickness (IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic progression. The investigators will also measure lipid and lipoprotein levels, inflammatory markers, markers of Cytomegalovirus (CMV) infection, thrombotic markers, atherogenic lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly collected blood and analyzed by flow cytometry to identify activated T-cells, T-cell turnover, proportions of T-cells, and CMV function. HIV-infected patients will have CD4 count and HIV viral load measured in addition. Patients will undergo detailed clinical history including HIV disease, specific HIV medications, comorbid conditions, and health related behaviors. Physical exam and measurements will be obtained to assess for the presence of lipodystrophy. Patients will undergo study visits for ultrasound, blood draw, and interview at 4-12 month intervals for the next 3 years. Patients will also go assessment of endothelial function, endothelial progenitor cells, arterial stiffness as measured using pulse wave tonometry. To demonstrate the feasibility of a larger scale investigation of cardiac arrhythmia in HIV positive and negative patients with cardiac disease, the investigators will use 48-hour Holter monitor surveillance to monitor HIV-infected and uninfected patients with a history of myocardial infarction, systolic left ventricular dysfunction, and/or pulmonary artery hypertension for the presence of cardiac arrhythmia. The FDG PET scan (18F-fluorodeoxyglucose positron emission tomography-computed tomography) will be used to detect and quantify inflammation in the body.

    at UCSF

  • Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)

    Sorry, in progress, not accepting new patients

    People infected with HIV often have cognitive dysfunction even if they are on antiretroviral therapy (ART) and have undetectable viral loads. The purpose of this study is to evaluate if the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral [ARV] medications) to participants' existing ART regimens will improve participants' neurocognitive performance.

    at UCLA UCSD

  • Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients

    Sorry, accepting new patients by invitation only

    Long term safety follow-up of Cal-1 recipients

    at UCLA

  • Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial

    Sorry, in progress, not accepting new patients

    The purpose of this study is to evaluate the potential effectiveness of losartan (100mg daily) for reducing inflammation and improving immune recovery.

    at UCSF

  • mHealth App for Engagement in Care Among Youth Living With HIV

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    In the US, fewer than 6% of all youth living with HIV (YLWH) achieve HIV viral suppression. However, health disparities among youth extend across the entire HIV care continuum in that there is a strong association between younger age and later HIV diagnosis, lower engagement in care, lower levels of antiretroviral therapy (ART) adherence, and worse HIV clinical outcomes. In response to this critical public health dilemma, the investigators propose to develop a novel mobile health application ("app") to improve engagement in health care and ART adherence and to pilot test this mobile health app in 18-29-year-old YLWH residing in San Francisco. The aims of this study are to: Aim 1: Build on a theory-guided model and formative work to complete the development of a novel personalized mobile health app for improved HIV clinical outcomes among YLWH (includes field test of initial release to ensure adequate usability and engagement). Aim 2: Conduct a pilot randomized trial to assess the feasibility, acceptability, and preliminary clinical impact (i.e., adherence, plasma HIV RNA, and CD4+ cell count) of the use of this app among YLWH and their healthcare providers. The investigators hypothesize that this mobile health app will be feasible and acceptable and will result in improved HIV clinical outcomes. Upon completion, the investigators will be ready to test the efficacy of this app in a subsequent large-scale randomized control trial among a population that is disproportionately impacted by HIV and at elevated risk for poor clinical outcomes.

    at UCSF

  • Nurse-Led Community Health Worker Adherence Model in 3HP Delivery Among Homeless Adults at Risk for TB Infection and HIV

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    Tuberculosis (TB) is the prototypical disease of poverty as it disproportionately affects marginalized and impoverished communities. In the US, TB rates are unacceptably high among homeless persons who have a 10-fold increase in TB incidence as compared to the general population. In California, the rate of TB is more than twice the national case rate and recent TB outbreaks have been alarming. Among persons with active TB disease, over 10% die during treatment, with mortality being even higher among homeless persons with TB. While TB can be prevented by treating TB infection (TBI) before it develops into infectious, symptomatic disease, individual factors such as high prevalence of psychosocial comorbidities, unstable housing and limited access to care have led to poor adherence and completion of TBI treatment among homeless persons. Given the complex health disparity factors that affect TBI treatment adherence among homeless persons, this study will assess the feasibility of a theoretically-based novel model of care among persons with TBI and complex chronic illnesses. This study will evaluate an innovative, community-based intervention that addresses critical individual level factors which are potential mechanisms that underlie health disparities in completing TBI treatment among the predominantly minority homeless. The study hypothesis is that improving these conditions, and promoting health by focused screening for TBI, and early detection and treatment for these vulnerable adults will improve TB treatment completion and prevent future TB disease. The proposed theoretically-based health promotion intervention focuses on: 1) completion of TBI treatment, 2) reducing substance use; 3) improving mental health; and 4) improving critical social determinants of TB risk (unstable housing and poor health care access) among homeless adults in the highest TB prevalence area in Los Angeles. A total of 76 homeless adults with TBI will receive this program which includes culturally-sensitive education, case management, and directly observed therapy (DOT) delivery of medication among patients who have been prescribed 3HP (12 weeks treatment for latent TB infection) by a medical provider. This study will determine whether this intervention can achieve higher completion rates than the 65% completion rate among homeless persons reported by previous TB programs.

    at UC Irvine UCLA

  • Optimization of a Tenofovir Enema for HIV Prevention

    Sorry, not currently recruiting here

    DREAM-01 is an early phase 1, open label, dose-escalation and variable osmolarity study to compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3 formulations of a tenofovir (TFV) enema. The goal of the study is to identify the dose and osmolarity of a TFV enema for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) which achieves the desired colonic mucosal mononuclear cells (MMC) tenofovir diphosphate (TFV-DP) target concentrations that have previously been shown to confer protection from HIV acquisition in men who have sex with men (MSM).

    at UCLA

  • Personalized HIV and STI Testing Tool

    Sorry, not yet accepting patients

    The PHASTT Study is focused on understanding of facilitators and barriers to mHealth use among young Black men who have sex with men (MSM), and testing a novel mobile app to increase HIV/STI testing and PrEP uptake.

    at UCSF

  • Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir

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    The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of a 90-day intravaginal ring (IVR) containing tenofovir (TFV).

    at UCSF

  • Pilot of Mpowerment for Young Men Who Have Sex With Men (YMSM) in Beirut

    Sorry, in progress, not accepting new patients

    This project will adapt and pilot a multi-level, community-based intervention to promote HIV prevention and sexual health among young men who have sex with men in Beirut.

    at UCSF

  • Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama

    Sorry, not yet accepting patients

    The overall goal of this 5-year Mentored Research Scientist Development K01-Award is to support Henna Budhwani, PhD, MPH to become an independent implementation science investigator in the field of HIV prevention. The proposed project seeks to address the HIV crisis in Alabama, where rates of undiagnosed HIV in black young men who have sex with men (YMSM, 18-29 years) exceed 20%. This project will adapt and test a behavioral intervention to promote HIV rapid testing in the community, deliver culturally appropriate prevention education, offer sociostructural support, and refer eligible participants for pre-exposure prophylaxis (PrEP). Four training objectives are proposed that are in lockstep with three specific aims.

    at UCSF

  • Pre-exposure Prophylaxis Accessibility Research and Evaluation 2

    Sorry, in progress, not accepting new patients

    This study is a controlled, un-blinded, two-arm, randomized (1:1) clinical trial to determine if providing high-risk subjects with a calculated risk score changes the likelihood of pre-exposure prophylaxis (PrEP) uptake.

    at UCSD

  • PREPARE (A5361s) Substudy of REPRIEVE (A5332)

    Sorry, in progress, not accepting new patients

    Aging with HIV may be related to an earlier development of frailty (weakness) or disability, including difficulties in tests of strength or walking speed. Few treatments have been shown to prevent or slow these impairments in people with or without HIV. Some studies have suggested that the class of drugs called statins (for example, pitavastatin) might be helpful in slowing frailty or disability. This might happen by decreasing fat within the muscle or by decreasing inflammation markers (substances in the blood that determine how the body reacts to infection or irritation) in the blood. Other studies have shown that statins increase the risk of muscle aches and pains. This substudy is being done to determine the impact of the drug pitavastatin on muscle.

    at UCLA UCSD UCSF

  • Prevalence and Predictors of Neurocognitive Impairment Among HIV-infected Patients

    Sorry, in progress, not accepting new patients

    Despite the advent of highly active antiretroviral therapy (HAART), the prevalence of neurocognitive impairment among HIV-infected patients continues to be an important issue. Although severe forms of AIDS-related dementia have diminished, milder forms of cognitive impairment have been noted among approximately 30% of asymptomatic HIV patients. Studies among HIV-infected U.S. military personnel regarding neurocognitive function have largely been limited to the early 1990s, before the advent of HAART. In these studies subtle neurobehavioral changes were noted among asymptomatic HIV-positive military personnel. This study proposes to determine the prevalence of neurocognitive deficits among HIV-positive military beneficiaries during the era of HAART who are participants of the U.S. Military HIV Natural History Study. The prevalence ascertained in this study will be compared to HIV-negative military beneficiaries who are demographically similar to the HIV positive group. The sample size of the study is to have complete testing on 200 HIV positive and 50 HIV-negative participants; due to the possibility of attrition before study completion, the investigators will enroll up to 300 participants (240 HIV-positive and 60 HIV-negative) to achieve this sample size. The investigators' rates among HIV-positive patients found in this study will also be contextualized in the setting of the prevalence of prior neurocognitive deficits seen in a HIV positive U.S. military population studied in the 1990s, contemporary rates among civilian HIV-infected persons, and normative values in the general HIV-negative population. Compared to other data in the field of neuropsychology, this study is novel in that the HIV population studied is composed largely of HIV patients who have been diagnosed early in their HIV infection; have open, free access to antiretrovirals to begin therapy earlier than most other cohorts; and consists of highly-functioning, educated individuals.

    at UCSD

  • Prospective Observational Epidemiologic Study of Maraviroc's Safety

    Sorry, in progress, not accepting new patients

    The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

    at UC Irvine UCSF

  • Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors

    Sorry, in progress, not accepting new patients

    The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).

    at UCSF

  • Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults

    Sorry, in progress, not accepting new patients

    The primary objectives of this study are to evaluate the safety and tolerability of vesatolimod (formerly GS-9620) at escalating, multiple doses of vesatolimod in HIV-1 infected virologically suppressed adults on antiretroviral therapy (ART) and to evaluate the virologic effect of vesatolimod as measured by changes in plasma HIV-1 RNA.

    at UCSD

  • Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in HIV-1 infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD) at Week 48.

    at UC Davis

  • Selective Estrogen Receptor Modulators to Enhance the Efficacy of Viral Reactivation With Histone Deacetylase Inhibitors

    Sorry, in progress, not accepting new patients

    This study will evaluate the effects of tamoxifen exposure in combination with vorinostat on viral reactivation among HIV-1 infected post-menopausal women with virologic suppression on antiretroviral therapy (ART), when compared to vorinostat alone.

    at UCLA UCSF

  • Strategic Timing of Antiretroviral Treatment

    Sorry, in progress, not accepting new patients

    Objectives: - To find out if the chance of developing a serious illness or of getting AIDS is less if patients start taking HIV medicines at a time when their cluster-of-differentiation-4 (CD4)+ cell count is still fairly high, instead of waiting until the CD4+ count is at the level where there is good evidence for starting medicines. - To learn more about how a strategy of starting HIV medicines early might affect other aspects of care, such as the chances of developing other illnesses or resistance to HIV medicines, the frequency of doctor visits, the cost of medical care, and general health and satisfaction.

    at UCLA UCSD

  • Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection

    Sorry, in progress, not accepting new patients

    This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.

    at UCSF

  • Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.

    at UC Davis UCLA

  • Study to Explore Natural Daily Variation and Impact of Stress in HIV Levels

    Sorry, in progress, not accepting new patients

    Despite advances in AntiRetroviral Therapy (ART) leading to a rapid control of the HIV virus in individuals affected, HIV can persist indefinitely and there is no cure. The HIV virus has been shown to have a unique ability to hide within the human gene inside human cells and in tissues, remaining 'silent' and rapidly reactivate 'waking up" if ART is stopped. There are a number of ways to measure the silent HIV reservoir, including a common research-based laboratory test called Cell-Associated UnSpliced (CA-US) HIV RNA. This is an early marker of the HIV virus waking up. It is often used to test how well new drugs developed to eliminate the silent virus might work. This study is examining whether the diurnal variation (daily rhythm) and/or stress can affect CA-US HIV RNA levels in individuals diagnosed with HIV and receiving ART.

    at UCSF

  • Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC

    Sorry, in progress, not accepting new patients

    The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.

    at UCSD

  • Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

    Sorry, in progress, not accepting new patients

    This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.

    at UCLA

  • Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.

    at UC Davis UCLA

  • Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

    Sorry, in progress, not accepting new patients

    This study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.

    at UC Davis

  • Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Adults Who Are Virologically Suppressed

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine (Emtriva®)/tenofovir alafenamide (Descovy®; F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (Truvada®; F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®; B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance as determined by the proportion of participants with human immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) ≥ 50 copies/mL at Week 48

    at UC Davis

  • Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B

    Sorry, in progress, not accepting new patients

    The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.

    at UCSF

  • Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas

    Sorry, in progress, not accepting new patients

    This partially randomized phase I/II trial studies the side effects and the best dose of vorinostat when given together with combination chemotherapy and rituximab to see how well it works compared to combination chemotherapy alone in treating patients with human immunodeficiency virus-related diffuse large B-cell non-Hodgkin lymphoma or other aggressive B-cell lymphomas. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving vorinostat together with combination chemotherapy and rituximab may kill more cancer cells.

    at UCSF UCSD UCLA

  • Women's Interagency HIV Study (WIHS)

    Sorry, in progress, not accepting new patients

    The Women's Interagency HIV Study (WIHS), a multicenter, prospective study, was established in August 1993 to carry out comprehensive investigations of the impact of HIV infection and its clinical, laboratory, and psychosocial effects in women. The purpose of this study is to collect and evaluate these data from HIV infected and at-risk women to better understand and provide support for women whom are currently HIV infected or who are at risk for HIV infection.

    at UCSF

  • Youth Services Navigation Intervention for HIV+ Adolescents and Young Adults Being Released From Incarceration

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    HIV prevalence among incarcerated youth living with HIV (YLWH) is three times that of the general population and one in seven of all HIV+ persons experience incarceration each year. Furthermore, only an estimated 6% of HIV+ youth achieve HIV viral load suppression, due to poor retention and adherence to anti-retroviral therapy (ART). Existing linkage and retention services are insufficient to meet the acute needs of criminal justice-involved (CJI) HIV+ youth, particularly in the high-need period following release from incarceration. The LINK2 study will develop and implement a youth service navigation (YSN) intervention to improve linkage and retention among CJI YLWH and analyze results to address existing gaps in the literature. The investigators will enroll 240 CJI YLWH, aged 16-25 (+364 days), incarcerated in Los Angeles and Chicago jails and through community clinics serving recently released CJI YLWH. Participants will be randomized to the YSN intervention (n=120) vs. a usual-care control group (n=120). The youth services navigators (YSNs) will assist with addressing immediate unmet needs such as housing, transportation, and food prior to clinical care and ongoing; will guide intervention participants to a range of community services to support progress along the continuum of HIV care; and will provide direct ART adherence support. The proposed study has two Primary Specific Aims: 1. Adapt an existing peer navigation intervention for adults to create a Youth Service Navigation (YSN) intervention sensitive to sexual and gender minority (SGM) culture that guides youth to needed services along the continuum of HIV care. This intervention combines medical, substance use and mental health care with comprehensive reentry support for CJI YLWH, aged 16-25 (+364 days) upon release from large county jails and juvenile detention systems; 2. Using a two-group RCT design, the study will test the effectiveness of the new YSN, youth SGM-sensitive intervention among CJI YLWH aged 16-25 (+364 days), compared to controls offered standard of care. The study team will evaluate the YSN Intervention's effect on post-incarceration linkage, retention, adherence, and viral suppression, as well as on substance use disorders, mental health, services utilization, and met needs. Secondary Aims are to assess the intervention's effects on recidivism, costs and potential cost-offset/effectiveness.

    at UCLA

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