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

NCT06101329 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: GS-US-528-6020
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 11

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 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.

Conditions

Pre-Exposure Prophylaxis of HIV Infection

Outcome Measures

Primary Outcomes (7)

• 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.

  Week 26

• PK Parameter: Ctrough for LEN at the End of Week 52

  Ctrough is defined as the concentration at the end of the dosing interval.

  Week 52

• Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  First dose date up to 30 days post last dose at Week 78

• Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities

  First dose date up to 30 days post last dose at Week 78

• 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.

  Up to Week 52

• 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.

  Up to Week 52

• 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.

  Up to Week 52

Secondary Outcomes (2)

• Number of Participants with Adherence to LEN, as Assessed by on-time LEN Injections Received

  Up to Week 26

• 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)

  Up to Week 78

Study Arms (3)

Randomized Phase: Lenacapavir (LEN) Group

EXPERIMENTAL

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; Drug: Lenacapavir Injection

Randomized Phase: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Group

EXPERIMENTAL

Participants will receive oral F/TDF (200/300 mg) daily for 52 weeks.

Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF)

PK Tail Phase: F/TDF

EXPERIMENTAL

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)

Interventions

Lenacapavir Tablet DRUG

Tablets administered orally without regard of food

Also known as: GS-6207

Randomized Phase: Lenacapavir (LEN) Group

Lenacapavir Injection DRUG

Injection administered subcutaneously

Also known as: GS-6207, Yeztugo®

Randomized Phase: Lenacapavir (LEN) Group

Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) DRUG

200/300mg fixed dose combination (FDC) tablets administered orally

Also known as: Truvada®

PK Tail Phase: F/TDF; Randomized Phase: Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• \) 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gilead Sciences: lead
• HIV Prevention Trials Network: collaborator

Study Sites (11)

UAB, 1917 Research Clinic

Birmingham, Alabama, 35222, United States

Location

UCSD Antiviral Research Center (AVRC)

San Diego, California, 92103, United States

Location

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Ponce de Leon Center Clinical Research Site

Atlanta, Georgia, 30303, United States

Location

Fenway Health

Boston, Massachusetts, 02215, United States

Location

Rutgers New Jesey Medical School - Clinical Research Center

Newark, New Jersey, 07103, United States

Location

Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, 10010, United States

Location

Harlem Prevention Center CRS

New York, New York, 10027, United States

Location

ICAP at Columbia University - Bronx Prevention Center

The Bronx, New York, 10451, United States

Location

NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Penn Prevention Research Unit

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

lenacapavir; Emtricitabine; Tenofovir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: November 17, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)