Status:
ACTIVE_NOT_RECRUITING
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
Lead Sponsor:
Gilead Sciences
Collaborating Sponsors:
HIV Prevention Trials Network
Conditions:
Pre-Exposure Prophylaxis of HIV Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical study is 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 prevention of HI...
Eligibility Criteria
Inclusion
- Key
- Report at least 1 episode of condomless vaginal or anal sex with a cisgender man in the 12 months before enrollment.
- Hepatitis B virus (HBV) surface antigen (HBsAg) negative.
- Self-report one or more of the following in the past 12 months (except for incarceration, which could have occurred in the past 5 years):
- 1\) Noninjection recreational drug use (ecstasy, cocaine, crack cocaine, methamphetamine, ketamine, 3,4-methylenedioxy-methamphetamine, or prescription drugs apart from those prescribed by a licensed provider); 2) Alcohol dependence (defined as Cut Down, Annoyed, Guilty, and Eye Opener score of 2); binge-drinking, defined as 4 or more drinks at a time; 3) History of STIs, such as gonorrhea, chlamydia, or syphilis; 4) Exchange of sex for commodities, such as drugs, money, or shelter; 5) Incarceration (jail or prison \> 24 hours within the past 5 years); 6) Two or more sexual partners who were assigned male at birth; 7) Sexual partner assigned male at birth with history of either injection or noninjection recreational drug use, sexually transmitted infections (STIs), human immunodeficiency virus (HIV) diagnosis or unknown HIV status, additional sex partners during the course of his sexual relationship with the individual, or incarceration (jail or prison \> 24 hours within the past 5 years)
- 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.
- One or more reactive or positive HIV test result at screening or enrollment, even if HIV infection is not confirmed.
- 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.
- Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding, etc).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2028
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT06101329
Start Date
November 17 2023
End Date
January 1 2028
Last Update
September 23 2025
Active Locations (11)
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1
UAB, 1917 Research Clinic
Birmingham, Alabama, United States, 35222
2
UCSD Antiviral Research Center (AVRC)
San Diego, California, United States, 92103
3
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037
4
Ponce de Leon Center Clinical Research Site
Atlanta, Georgia, United States, 30303