Status:
ACTIVE_NOT_RECRUITING
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
HIV Prevention Trials Network
National Institute on Drug Abuse (NIDA)
Conditions:
Pre-Exposure Prophylaxis of HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 (F/TDF) for pre-exposure p...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT06101342
Start Date
December 13 2023
End Date
December 1 2028
Last Update
August 21 2025
Active Locations (9)
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1
UCLA Vine Street Clinic
Los Angeles, California, United States, 90038
2
UCSD AntiViral Research Center (AVRC)
San Diego, California, United States, 92103
3
University of Miami - Converge Miami Building
Miami, Florida, United States, 33136
4
Johns Hopkins Medicine Institute for Clinical and Translational Research, Clinical Research
Baltimore, Maryland, United States, 21287