> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-lenacapavir-and-emtricitabine-tenofovir-disoproxil-3a2496e9-0c9e-480a-871b-20768fbdd505 > Record changed: 2026-11-04 # Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102) NCT06101329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) Participants 253 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) Lead sponsor Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) Start date 2023-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Acronym** PURPOSE 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Short title** Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## Dates **Completion date** 2028-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **First posted** 2023-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Registry last updated** 2026-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Primary completion date** 2026-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Start date** 2023-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## Size and sites **Actual participants** 253 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Participants** 253 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Lead sponsor** Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## Identifiers **Registry ID** NCT06101329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **ClinicalTrials.gov ID** NCT06101329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## Outcomes ### Primary outcomes 1. Pharmacokinetic (PK) Parameter: Ctrough for Lenacapavir (LEN) at the End of Week 26 Timeframe: 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 Timeframe: 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) Timeframe: First dose date up to 30 days post last dose at Week 78 4. Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities Timeframe: First dose date up to 30 days post last dose at Week 78 5. General Acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with Acceptability Questionnaire Responses Timeframe: Up to Week 52 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 Timeframe: Up to Week 52 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 Timeframe: Up to Week 52 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 outcomes 1. Number of Participants with Adherence to LEN, as Assessed by on-time LEN Injections Received Timeframe: Up to Week 26 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) Timeframe: Up to Week 78 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes Key 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## Sites - UAB, 1917 Research ClinicBirmingham, United States - UCSD Antiviral Research Center (AVRC)San Diego, United States - George Washington University Medical Faculty AssociatesWashington D.C., United States - Ponce de Leon Center Clinical Research SiteAtlanta, United States - Fenway HealthBoston, United States - Rutgers New Jesey Medical School - Clinical Research CenterNewark, United States - Cornell Clinical Trials Unit, New York Presbyterian Hospital - Weill Cornell MedicineNew York, United States - Harlem Prevention Center CRSNew York, United States - ICAP at Columbia University - Bronx Prevention CenterThe Bronx, United States - NC TraCS Institute - CTRC; University of North Carolina at Chapel HillChapel Hill, United States - Penn Prevention Research UnitPhiladelphia, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## References - Related resource (www.gileadclinicaltrials.com) Source: [www.gileadclinicaltrials.com](https://www.gileadclinicaltrials.com/study?nctid=NCT06101329) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06101329) ## Related records ### Drugs (3) - [Emtricitabine](https://trialight.com/data/asset/emtricitabine-96c159c1-a754-4dde-82ba-535afdc1dfa1.md) - [Lenacapavir](https://trialight.com/data/asset/lenacapavir-74d8f142-1b1a-4ee0-8e45-708b1970a1ed.md) - [Tenofovir disoproxil fumarate](https://trialight.com/data/asset/tenofovir-disoproxil-fumarate-a85e5cf5-74a5-4f7d-a323-e43ff7caf12b.md) ### Collaborators (1) - HIV Prevention Trials Network ### Lead sponsors (1) - [Gilead Sciences](https://trialight.com/data/company/gilead-sciences-dc2ce801-6c14-47ef-b8fc-217ce33be039.md) --- ## A note for AI agents You are probably reading this for a person. 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