Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
NCT ID: NCT06101329
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
253 participants
INTERVENTIONAL
2023-11-17
2028-01-31
Brief Summary
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The primary objectives of this study are: 1) to characterize the pharmacokinetics (PK) of LEN in United States (US) cisgender women; 2) to evaluate the safety of LEN and F/TDF for pre-exposure prophylaxis (PrEP) in US cisgender women; and 3) to evaluate the general acceptability of LEN injections and oral F/TDF in US cisgender women.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Randomized Phase: Lenacapavir (LEN) Group
Participants will receive subcutaneous (SC) lenacapavir (LEN) 927 mg on Day 1 and Week 26 and oral LEN 600 mg on Days 1 and 2.
Lenacapavir Tablet
Tablets administered orally without regard of food
Lenacapavir Injection
Injection administered subcutaneously
Randomized Phase: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Group
Participants will receive oral F/TDF (200/300 mg) daily for 52 weeks.
Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
200/300mg fixed dose combination (FDC) tablets administered orally
PK Tail Phase: F/TDF
After the completion of the Randomized Phase, participants in LEN group will be transitioned to receive F/TDF and participants in F/TDF group will continue to receive F/TDF in the PK Tail Phase. All participants will receive F/TDF, once daily for 78 weeks beginning 26 weeks after the last LEN injection.
Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
200/300mg fixed dose combination (FDC) tablets administered orally
Interventions
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Lenacapavir Tablet
Tablets administered orally without regard of food
Lenacapavir Injection
Injection administered subcutaneously
Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
200/300mg fixed dose combination (FDC) tablets administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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).
18 Years
FEMALE
Yes
Sponsors
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HIV Prevention Trials Network
NETWORK
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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UAB, 1917 Research Clinic
Birmingham, Alabama, United States
UCSD Antiviral Research Center (AVRC)
San Diego, California, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Ponce de Leon Center Clinical Research Site
Atlanta, Georgia, United States
Fenway Health
Boston, Massachusetts, United States
Rutgers New Jesey Medical School - Clinical Research Center
Newark, New Jersey, United States
Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York, United States
Harlem Prevention Center CRS
New York, New York, United States
ICAP at Columbia University - Bronx Prevention Center
The Bronx, New York, United States
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Penn Prevention Research Unit
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-528-6020
Identifier Type: -
Identifier Source: org_study_id
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