Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSD
Dates
study started
completion around

Description

Summary

The goals of this clinical study are to look at how lenacapavir (LEN) passes through the body and to assess the safety of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF) for pre-exposure prophylaxis (PrEP) in people who inject drugs (PWID) in the United States (US).

The primary objectives of this study are:

  • To characterize the pharmacokinetics (PK) of LEN.
  • To evaluate the safety of LEN and F/TDF for PrEP in US PWID.

Official Title

A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics and Safety of Twice Yearly Long-Acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in People Who Inject Drugs

Keywords

Pre-Exposure Prophylaxis of HIV Infection, HIV Infections, Tenofovir, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Emtricitabine, Lenacapavir Injection, Lenacapavir Tablet, Emtricitabine/tenofovir disoproxil fumarate (F/TDF)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Urine drug screen positive for any drug of misuse including, but not limited to, opioids (eg, fentanyl, heroin), stimulants (eg, cocaine, amphetamines), psychoactive drugs (eg, benzodiazepines), or a combination of these drugs.
  • Evidence of recent injection (eg, track marks).
  • Self-report of injection paraphernalia sharing in the prior 30 days.
  • Hepatitis B virus (HBV) surface antigen (HBsAg) negative.
  • Negative local rapid HIV-1/2 antibody (Ab)/antigen (Ag) test, central HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT).
  • Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).

You CAN'T join if...

  • Self-reported history of previous positive results on an HIV test.
  • Any reactive or positive HIV test result at screening or enrollment, even if HIV infection is not confirmed.
  • Coenrollment in any other interventional research study or other concurrent studies that may interfere with this study (as provided by self-report or other available documentation) without prior approval from the Medical Monitor/Joint Clinical Management Committee while participating in this study.
  • Past or current participation in HIV vaccine or HIV broadly neutralizing antibody study unless individual provides documentation of receipt of placebo (ie, not active product).
  • Prior use of long-acting systemic pre-exposure prophylaxis (PrEP) (including cabotegravir (CAB) or islatravir studies).
  • Acute viral hepatitis A or acute or chronic hepatitis B or C infection.
  • Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc).
  • Evidence of moderate or severe liver fibrosis or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding)

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Location

  • UCSD AntiViral Research Center (AVRC) accepting new patients
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Gilead Clinical Trials Website
ID
NCT06101342
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 250 study participants
Last Updated