Summary

for females ages 16 years and up (full criteria)
at UCLA
study started
estimated completion:

Description

Summary

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.

Official Title

A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Two Different Potent Regimens in HIV Infected Women Initiating Triple Antiretroviral Regimens Between 20 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child Transmission: NICHD P1081

Details

While there are many ARV medications and combination regimens available to treat HIV-infected people, the number of ARV medications studied in HIV-infected pregnant women for the prevention of mother-to-child transmission remains limited. HIV-infected pregnant women who begin taking ARV medications late in their pregnancies require effective therapy to reduce the risk of transmitting HIV to their children. Currently, there is no data available that compares the effects of non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitors (which are two classes of ARV medications) in pregnant women. The purpose of this study is to compare the safety, tolerance, and virologic and pharmacologic responses to two different medication regimens, each including an NNRTI or integrase inhibitor, in pregnant HIV-infected women who begin ARV therapy late in their pregnancies (i.e., a gestational age between 20 and 36 weeks).

Participants in this study will be randomly assigned to one of two arms. Participants in Arm A will receive lamivudine 150 mg/zidovudine 300 mg twice a day and efavirenz 600 mg each night. Participants in Arm B will receive lamivudine 150 mg/zidovudine 300 mg twice a day and raltegravir 400 mg twice a day. All participants will receive their assigned medications from study entry through delivery. Participants will attend study visits at entry and Weeks 1, 2, and 4; and thereafter, every two weeks until labor and delivery. Study visits will include a medical history review, physical examination, questionnaires, blood collection, and a vaginal swab procedure.

While participants are in labor, they will continue to receive their study medications. Some participants may receive additional or alternate medications according to local standard of care/guidelines. Participants will have a physical examination and blood collection. After delivery, some women will continue to receive ARV medications according to the local guidelines. Participants will attend study visits following the delivery at Weeks 2 to 4, 6, 16, and 24, which will include a medical history review, physical examination, and blood collection. One study visit will include a vaginal swab procedure. Some participants may have vaginal specimens stored for future research.

Participants' babies will receive ARV medications as prescribed by the babies' doctors. Study visits for babies will occur at birth; Weeks 2 to 4, 6, 16, and 24. Each study visit will include a medical history review, physical examination, and blood collection. Select visits will include oral and nasopharyngeal swab collection.

Keywords

HIV Infections Lamivudine Efavirenz Zidovudine Reverse Transcriptase Inhibitors Lamivudine, zidovudine drug combination Raltegravir Potassium Lamivudine/zidovudine Raltegravir

Eligibility

You can join if…

Open to females ages 16 years and up

  • Naive to antiretroviral therapy (ART) or have received ART with short course zidovudine (maximum of 8 weeks) for prevention of mother-to-child transmission in previous pregnancies
  • Willing and able to sign informed consent. Participant must be of an age to provide legal informed consent as defined by the country in which the participant resides. If not, the informed consent must be signed by a legal guardian/parent, as per country guidelines.
  • Documentation of HIV-1 infection defined as positive results from two samples collected at different time points. The same method may be used at both time points.All samples tested must be whole blood, serum, or plasma. Documentation may be abstracted from medical records to satisfy these criteria for infection. More information on this criterion can be found in the protocol.
  • Viable pregnancy with gestational age of greater than or equal to 20 weeks to less than or equal to 36 weeks based upon menstrual history and/or ultrasound. Note: If menstrual history is unknown or if there is a discrepancy between menstrual history and ultrasound, determination of gestational age should be based upon best available methodology at each site.
  • Intends to continue pregnancy
  • Willingness and intent to deliver at the participating clinical site and to be followed for the duration of the study at the site or associated outpatient facility
  • Willing to comply with the study regimen
  • Agrees to use two reliable methods of contraception after delivery if randomized to the efavirenz arm and is sexually active. A barrier method of contraception (condoms,diaphragm, or cervical cap) together with another reliable form of contraception must be used for 4 weeks after stopping efavirenz.

You CAN'T join if...

  • Active labor defined as onset of regular contractions or cervical dilatation greater than 2 cm
  • Use of ART during current pregnancy
  • Chemotherapy for active malignancy
  • HIV genotypic resistance, as defined in the protocol, to efavirenz or raltegravir or to NRTIs that will be included in the ART regimen. Note: A lack of HIV drug resistance test results at the time of enrollment is not exclusionary.
  • Serious active opportunistic infection and/or serious bacterial infection including active tuberculosis (TB) or unstable or severe medical condition within 14 days of study entry
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study
  • Vomiting or inability to swallow medications due to an active, pre-existing condition that prevents adequate swallowing and absorption of study medication
  • Known allergy/sensitivity to any study drugs or their formulations or sulfonamide allergy
  • The following laboratory values (within 30 days of enrollment):
  • Hemoglobin greater than or equal to Grade 3
  • Absolute neutrophil count greater than or equal to Grade 2
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to Grade 2
  • Serum creatinine greater than or equal to Grade 1
  • Platelet count greater than or equal to Grade 3
  • Evidence of pre-eclampsia (such as persistent diastolic blood pressure greater than 90 mm Hg)
  • Receipt of disallowed medications as described in the protocol

Locations

  • David Geffen School of Medicine at UCLA NICHD CRS
    Los Angeles California 90095-1752 United States
  • University of Southern California Medical Center
    Los Angeles California 90033 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Westat
ID
NCT01618305
Phase
Phase 4
Study Type
Interventional
Last Updated