Preventing HIV in people who inject drugs using lenacapavir and F/TDF
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
This study is testing if a new combination of medications can safely help people who inject drugs in the U.S. prevent HIV.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gilead Sciences Industry-sponsored |
| Locations | 9 sites (Los Angeles, California and 8 other locations) |
| Trial ID | NCT06101342 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate how lenacapavir (LEN) is processed in the body and to assess the safety of LEN combined with emtricitabine/tenofovir disoproxil fumarate (F/TDF) for pre-exposure prophylaxis (PrEP) in individuals who inject drugs in the United States. The primary objectives include characterizing the pharmacokinetics of LEN and determining the safety profile of both LEN and F/TDF in this population. Participants will be monitored for their response to the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who inject drugs and have a recent history of sharing injection paraphernalia.
Not a fit: Patients who are already HIV positive or have a history of positive HIV test results will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective preventive measure against HIV for people who inject drugs.
How similar studies have performed: Other studies have shown promise in using similar approaches for HIV prevention, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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). Key Exclusion Criteria: * 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). In individuals with active hepatitis C, Fibrosis-4 (FIB-4) score \> 3.25 (formula provided below). Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Los Angeles, California and 8 other locations
- UCLA Vine Street Clinic — Los Angeles, California, United States (Recruiting)
- UCSD AntiViral Research Center (AVRC) — San Diego, California, United States (Recruiting)
- University of Miami - Converge Miami Building — Miami, Florida, United States (Recruiting)
- Johns Hopkins Medicine Institute for Clinical and Translational Research, Clinical Research — Baltimore, Maryland, United States (Recruiting)
- Rutgers New Jersey Medical School, Department of Medicine — Newark, New Jersey, United States (Recruiting)
- ICAP at Columbia University- Bronx Prevention Center — Bronx, New York, United States (Recruiting)
- University of Pennsylvania, Division of Infectious Diseases Penn Prevention Research Unit — Philadelphia, Pennsylvania, United States (Recruiting)
- Houston AIDS Research Team CRS — Houston, Texas, United States (Recruiting)
- West Virginia University — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Gilead Clinical Study Information Center
- Email: GileadClinicalTrials@gilead.com
- Phone: 1-833-445-3230 (GILEAD-0)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.