> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-lenacapavir-taken-twice-a-year-for-hiv-pre-exposure-c2efcf1c-fddc-4908-8153-bc4df39d2565 > Record changed: 2026-11-04 # Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP) NCT06513312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) Participants 268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) Lead sponsor Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) Start date 2024-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## Title and summary **Summary** The goals of this clinical study are to learn more about the study drug lenacapavir (LEN), by comparing the consistent and continuous use of LEN and emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®) (F/TDF), then by observing the safety of LEN and F/TDF, evaluating the acceptability of LEN injections and oral F/TDF, and observe how LEN moves throughout the body in people who would benefit from pre-exposure prophylaxis (PrEP). The primary objective of this study is to compare LEN and F/TDF consistent and continuous use among people who would benefit from PrEP. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Acronym** PURPOSE 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Short title** Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Official title** A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Persistence, Safety, Acceptability, and Pharmacokinetics of Twice Yearly Long-acting Subcutaneous Lenacapavir for HIV Pre-Exposure Prophylaxis (PrEP) in People Who Would Benefit From PrEP Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## Dates **Completion date** 2028-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **First posted** 2024-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Registry last updated** 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Primary completion date** 2026-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Start date** 2024-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## Size and sites **Actual participants** 268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Participants** 268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Lead sponsor** Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## Identifiers **Registry ID** NCT06513312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **ClinicalTrials.gov ID** NCT06513312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## Outcomes ### Primary outcomes 1. Percentage of Participants with LEN and F/TDF Persistence through 52 Weeks Timeframe: Up to Week 52 This outcome measure will compare LEN and F/TDF persistence through 52 weeks, where persistence is defined by On-time LEN Injection at Day 1/Baseline and Week 26 and On-time Follow-up Visit at Week 52 for LEN arm and by Adherence Levels Based on tenofovir diphosphate (TFV-DP) concentrations in red blood cells consistent with ≥ 4 doses/week (≥ 700 fmol/punch) in dried blood spot (DBS) at Weeks 13, 26, 39, and 52 for F/TDF arm. ### Secondary outcomes 1. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Timeframe: First dose date up to 30 days post last dose at Week 78 2. Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities Timeframe: First dose date up to 30 days post last dose at Week 78 3. Overall acceptability of LEN and F/TDF as PrEP as Assessed by Percentage of Participants with responses to Question on Acceptability 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. 4. Pharmacokinetic (PK) Parameter: Ctrough for LEN at Week 26 Timeframe: Week 26 Ctrough is defined as the concentration at the end of the dosing interval. 5. PK Parameter: Ctrough for LEN at Week 52 Timeframe: Week 52 Ctrough is defined as the concentration at the end of the dosing interval. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes Key Inclusion Criteria: - Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of study procedures. - Cisgender men who have sex with men, transgender women, transgender men, cisgender women, and nonbinary people. - Increased likelihood of HIV acquisition as indicated by at least one of the following: 1. Condomless sex with ≥ 2 partners in the past 6 months 2. Diagnosis of a bacterial sexually transmitted infection (STI) in the past 12 months 3. Engagement in sex work or transactional sex in the past 12 months 4. Use of ≥ 2 courses of nonoccupational HIV post-exposure prophylaxis (nPEP) in the past 12 months 5. Condomless sex with a partner living with HIV who has unknown or unsuppressed viral load (≥ 200 copies/mL) in the past 12 months - 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) at screening. 1) If rapid HIV-1/2 Ab/Ag tests are unavailable due to extenuating circumstances, sites may run a laboratory-instrumented HIV-1/2 Ab/Ag test at their local laboratory, only if they confirm this is a fourth-generation assay and the time from blood draw to injection at any injection visit is < 48 hours. - Estimated glomerular filtration rate (GFR) at least 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr): - (140 - age in years) × (weight in kg) x (0.85 if female) = CLcr (mL/min) / 72 × (serum creatinine in mg/dL) Key Exclusion Criteria: - Coenrollment in any other clinical study (including observational) without prior approval from the sponsor is prohibited while participating in this study. - Known hypersensitivity to the study drug, the metabolites, or formulation excipient. - Current use of PrEP, defined as the use of PrEP in the preceding 4 weeks. PrEP should not be discontinued to facilitate study participation. For cabotegravir, this is defined as 4 weeks since the next injection was due (ie, 12 weeks since their most recent cabotegravir injection). - Current use of nPEP, unless the prescribed course will be completed prior to randomization. - Past or current participation in HIV vaccine or HIV broadly neutralizing Ab study unless participant provides documentation of receipt of placebo (ie, not active product). - Acute viral hepatitis A, B, or C or evidence of chronic hepatitis B or C infection - Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding). - Have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc). Note: Other protocol defined Inclusion/Exclusion criteria may apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## Sites - Hopital AvicenneBobigny, France - Hopital Europeen MarseilleMarseille, France - CHU Nice ArchetNice, France - Hopital Saint Louis - Assistance Publique des Hopitaux de ParisParis, France - APHP Hopital Saint-AntoineParis, France - APHP Bichat Claude-Bernard HospitalParis, France - University Hospitals Birmingham NHS Foundation Trust, Birmingham Heartlands HospitalBirmingham, United Kingdom - Clinical Research Facility, University Hospitals Sussex NHS Foundation TrustBrighton, United Kingdom - Axess Sexual Health, Liverpool University Hospitals NHS TrustLiverpool, United Kingdom - Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital, Barts Health NHS TrustLondon, United Kingdom - Homerton Healthcare NHS Foundation Trust, Homerton University HospitalLondon, United Kingdom - Caldecot Centre, Kings College Hospital, Kings College Hospital NHS Foundation TrustLondon, United Kingdom - Chelsea and Westminster Hospital NHS Foundation Trust, Clinical Research Facility, Chelsea and Westminster HospitalLondon, United Kingdom - Manchester University NS Foundation TrustManchester, United Kingdom Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## References - Related resource (www.gileadclinicaltrials.com) Source: [www.gileadclinicaltrials.com](https://www.gileadclinicaltrials.com/study?nctid=NCT06513312) ### Other registry identifiers (2) - 2023 - 2023-507891-31 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06513312) ## 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) ### 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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