> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-an-injectable-regimen-of-gs-3242-with-lenacapavir-03b377f2-b491-452d-ac1c-4bba8418d4be > Record changed: 2026-11-04 # Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment NCT07708727 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) Participants 700 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) Lead sponsor Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) Start date 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) Number of sites 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## Title and summary **Summary** The study will have two portions: Phase 2 and Phase 3\. Phase 2 will further have 2 parts: Part A and Part B. The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35\. The goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26\. The goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52\. The primary objectives of this study are: Phase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35\. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26\. Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Short title** Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Official title** An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## Dates **Completion date** 2033-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **First posted** 2026-07-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Registry last updated** 2026-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Primary completion date** 2030-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Start date** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## Size and sites **Participants** 700 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Planned participants** 700 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Number of sites** 16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Lead sponsor** Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## Identifiers **Registry ID** NCT07708727 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **ClinicalTrials.gov ID** NCT07708727 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## Outcomes ### Primary outcomes 1. Phase 2: Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm Timeframe: Week 35 2. Phase 2: Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm Timeframe: Week 26 3. Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm Timeframe: Week 52 ### Secondary outcomes 1. Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Determined by the US FDA Snapshot Algorithm Timeframe: Week 12 2. Phase 2: Parts A and B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm Timeframe: Week 52 3. Phase 2: Parts A and B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12 Timeframe: Baseline, Week 12 4. Phase 2: Part A: Change From Baseline in CD4 Cell Count at Week 35 Timeframe: Baseline, Week 35 5. Phase 2: Parts A and B: Change From Baseline in CD4 Cell Count at Week 52 Timeframe: Baseline, Week 52 6. Phase 2: Part B: Change From Baseline in CD4 Cell Count at Week 26 Timeframe: Baseline, Week 26 7. Phase 2: Parts A and B: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 12 Timeframe: From first dose date up to Week 12 8. Phase 2: Part A: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 35 Timeframe: Week 35 9. Phase 2: Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26 Timeframe: From first dose date up to Week 26 10. Phase 2: Parts A and B and Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52 Timeframe: From first dose date up to Week 52 11. Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 18 Timeframe: Week 18 12. Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 35 Timeframe: Week 35 13. Phase 2: Part A and Part B: Trough Concentrations of GS-3242 and LEN at Week 52 Timeframe: Week 52 14. Phase 2: Part B: Trough Concentrations of GS-3242 and LEN at Week 26 Timeframe: Week 26 15. Phase 3: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 104 as determined by the US FDA snapshot algorithm Timeframe: Week 104 16. Phase 3: Change From Baseline in CD4 Cell Count at Week 52 Timeframe: Baseline, Week 52 17. Phase 3: Change From Baseline in CD4 Cell Count at Week 104 Timeframe: Baseline, Week 104 18. Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52 Timeframe: From first dose up to Week 52 19. Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 104 Timeframe: From first dose up to Week 104 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening. - Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening. Key Exclusion Criteria: - Prior usage of, or exposure to LEN or GS-3242 - Prior use of any long-acting parenteral ARV therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine. Note: Other protocol defined Inclusion/Exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## Sites - Lundquist Inst Biomedical Innovation Harbor-UCLATorrance, United StatesRecruiting - Yale University; School of Medicine; AIDS ProgramNew Haven, United StatesRecruiting - Midway Immunology and Research CenterFt. Pierce, United StatesRecruiting - Orlando Immunology Center, PAOrlando, United StatesRecruiting - Triple O Research Institute, P.A.West Palm Beach, United StatesRecruiting - Emory University Hospital Midtown Infectious Disease ClinicAtlanta, United StatesRecruiting - Metro Infectious Disease Consultants, P.L.L.CDecatur, United StatesRecruiting - KC care Health CenterKansas City, United StatesRecruiting - St Hope Foundation, Inc,Bellaire, United StatesRecruiting - Prism Health North TexasDallas, United StatesRecruiting - North Texas Infectious Diseases Consultants, PADallas, United StatesRecruiting - Texas Centers for Infectious Disease AssociatesFort Worth, United StatesRecruiting - McGill University Health CentreDecarie Montreal, CanadaRecruiting - CHU de Québec-Université LavalQuébec, CanadaRecruiting - Proyecto ACTURio Piedras, Puerto RicoRecruiting - HOPE Clinical ResearchSan Juan, Puerto RicoRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## References - Related resource (www.gileadclinicaltrials.com) Source: [www.gileadclinicaltrials.com](https://www.gileadclinicaltrials.com/study?nctid=NCT07708727) ### Other registry identifiers - 2026-526026-40 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07708727) ## Related records ### Drugs (1) - [Lenacapavir](https://trialight.com/data/asset/lenacapavir-74d8f142-1b1a-4ee0-8e45-708b1970a1ed.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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