Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
- 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.
- Short title
- Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2/Phase 3
- Study type
- Interventional
- Completion date
- 2033-04-01
- First posted
- 2026-07-16
- Registry last updated
- 2026-10-13
- Primary completion date
- 2030-10-01
- Start date
- 2026-07-29
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Gilead Sciences
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07708727
- ClinicalTrials.gov ID
- NCT07708727
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
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
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
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
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
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
Phase 2: Parts A and B: Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 12
Timeframe: Baseline, Week 12
Phase 2: Part A: Change From Baseline in CD4 Cell Count at Week 35
Timeframe: Baseline, Week 35
Phase 2: Parts A and B: Change From Baseline in CD4 Cell Count at Week 52
Timeframe: Baseline, Week 52
Phase 2: Part B: Change From Baseline in CD4 Cell Count at Week 26
Timeframe: Baseline, Week 26
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
Phase 2: Part A: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 35
Timeframe: Week 35
Phase 2: Part B: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 26
Timeframe: From first dose date up to Week 26
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
Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 18
Timeframe: Week 18
Phase 2: Part A: Groups 1 and 2: Trough Concentrations of GS-3242 and LEN at Week 35
Timeframe: Week 35
Phase 2: Part A and Part B: Trough Concentrations of GS-3242 and LEN at Week 52
Timeframe: Week 52
Phase 2: Part B: Trough Concentrations of GS-3242 and LEN at Week 26
Timeframe: Week 26
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
Phase 3: Change From Baseline in CD4 Cell Count at Week 52
Timeframe: Baseline, Week 52
Phase 3: Change From Baseline in CD4 Cell Count at Week 104
Timeframe: Baseline, Week 104
Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 52
Timeframe: From first dose up to Week 52
Phase 3: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 104
Timeframe: From first dose up to Week 104
- 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.
- 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
- Related resource (www.gileadclinicaltrials.com)
Other registry identifiers
- 2026-526026-40