Study of an Injectable Regimen of GS-3242 with Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
Key facts
- Where
- Barcelona, Granada, L'hospitalet De Llobregat, Madrid és Valencia, SpanyolországSee the 6 sites
- Phase
- 2/3. fázis
Where in Spanyolország
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
- Hospital Universitario Virgen de las NievesGranada, SpanyolországTaking people
- Bellvitge University HospitalL'hospitalet De Llobregat, SpanyolországTaking people
- Hospital Universitario Infanta LeonorMadrid, SpanyolországTaking people
- Hospital Universitario La PazMadrid, SpanyolországTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gilead Sciences Inc.
- Trial code
- EU 2026-526026-40-00
- Record updated
- 2026. október 21.
- Original description
1. Phase 2: Part A: To evaluate the efficacy of GS-3242 plus lenacapavir (LEN, Sunlenca®) versus bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF; 50/200/25 mg) in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35 2. Phase 2: Part B: To evaluate the efficacy of GS-3242 plus LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26 3. Phase 3: To evaluate the efficacy of GS-3242 plus LEN versus B/F/TAF in treatment-naive PWH at Week 52Read full original descriptionShow less
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
1. Phase 2: Part A: To evaluate the efficacy of GS-3242 plus lenacapavir (LEN, Sunlenca®) versus bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF; 50/200/25 mg) in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35 2. Phase 2: Part B: To evaluate the efficacy of GS-3242 plus LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26 3. Phase 3: To evaluate the efficacy of GS-3242 plus LEN versus B/F/TAF in treatment-naive PWH at Week 52
Inclusion: HIV-1 RNA ≥ 500 copies/mL at screening; ARV treatment-naive, except for prior use of oral daily PrEP or PEP up to 1 month prior to screening.
Exclusion: 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.