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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified August 2025 by Gilead Sciences
Sponsor
Gilead Sciences
Information Provided by (Responsible Party)
Gilead Sciences
Clinicaltrials.gov Identifier
NCT06101329
Other Study ID Numbers:
GS-US-528-6020
First Submitted
October 19, 2023
First Posted
October 25, 2023
Last Update Posted
September 22, 2025
Last Verified
August 2025

ClinicalTrials.gov processed this data on September 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Pre-Exposure Prophylaxis of HIV Infection
Drug: Lenacapavir TabletDrug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)

Study Design

Study TypeInterventional
Actual Enrollment253 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposePrevention
Official TitleA 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
Study Start DateNovember 16, 2023
Actual Primary Completion Date2w 3d from now
Actual Study Completion Date1yr 6mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
Drug: Lenacapavir Tablet
Tablets administered orally without regard of food
Randomized Phase: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Group
Participants will receive oral F/TDF (200/300 mg) daily for 52 weeks.
Drug: 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.
Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)
200/300mg fixed dose combination (FDC) tablets administered orally

Outcome Measures

Primary Outcome Measures
  1. Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN) at the End of Week 26
    Ctrough is defined as the concentration at the end of the dosing interval.
  2. PK Parameter: Ctrough for LEN at the End of Week 52
    Ctrough is defined as the concentration at the end of the dosing interval.
  3. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
  4. Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
  5. General Acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Acceptability Questionnaire Responses
    To assess the acceptability of the study drug, participants will complete the questionnaire including a question on general acceptability of the assigned study drug on an ordinal 5-category scale with a response of: Completely unacceptable, Unacceptable, No opinion, Acceptable, or Completely acceptable.
  6. Satisfaction With Use of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Satisfaction Questionnaire Responses
    To assess the satisfaction with use of the study drug, participants will complete the questionnaire including a question on satisfaction with use of the assigned study drug on an ordinal 5-category scale with a response of: Very satisfied, Satisfied, Neutral, Dissatisfied, or Very dissatisfied.
  7. Willingness to Use LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Willingness to Use Questionnaire Responses
    To assess the willingness to use the study drug, participants will complete the questionnaire including a question on willingness to use the assigned study drug on an ordinal 5-category scale with a response of: Definitely Yes, Probably yes, Not sure/undecided, Probably No, or Definitely No.
Secondary Outcome Measures
  1. Number of Participants with Adherence to LEN, as Assessed by on-time LEN Injections Received
  2. Number of Participants with Adherence to F/TDF, as Assessed by Adherence Levels Based on Tenofovir diphosphate (TFV-DP) Concentrations in Dried Blood Spot (DBS)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersYes
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). Key
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). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Sponsors and CollaboratorsGilead Sciences
Locations
UAB, 1917 Research Clinic | Birmingham Alabama, United States, 35222UCSD Antiviral Research Center (AVRC) | San Diego California, United States, 92103George Washington University Medical Faculty Associates | Washington D.C. District of Columbia, United States, 20037Ponce de Leon Center Clinical Research Site | Atlanta Georgia, United States, 30303Fenway Health | Boston Massachusetts, United States, 02215Rutgers New Jesey Medical School - Clinical Research Center | Newark New Jersey, United States, 07103Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine | New York New York, United States, 10010Harlem Prevention Center CRS | New York New York, United States, 10027ICAP at Columbia University - Bronx Prevention Center | The Bronx New York, United States, 10451NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill | Chapel Hill North Carolina, United States, 27599Penn Prevention Research Unit | Philadelphia Pennsylvania, United States, 19104
Investigators
Study Director: Gilead Study Director, Gilead Sciences