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Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102) | Clinical Trials | Clareo Health

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Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)

A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States

NCT06101329•Gilead Sciences

View on ClinicalTrials.gov

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 HIV in the cisgender women in the US. 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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•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).

Exclusion Criteria

•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).

Locations (11)

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

Key Dates

Start Date

November 17, 2023

Primary Completion Date

July 1, 2026

Completion Date

January 1, 2028

Last Updated

September 23, 2025

Enrollment

253

ACTUAL participants

Conditions

Pre-Exposure Prophylaxis of HIV Infection

Interventions

Lenacapavir Tablet

DRUG

Lenacapavir Injection

DRUG

Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)

DRUG

Evaluating the Healthy Families PrEP Program for Women at Risk for HIV

NCT06746675

HIVPregnancy+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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