GS-3242 with lenacapavir injections compared to Biktarvy in adults starting HIV-1 treatment
Compares injected GS-3242 plus lenacapavir with Biktarvy in adults new to HIV-1 treatment.
Key facts
- Who runs it
- Gilead Sciences Inc.
- Where
- Baloteşti, Bucharest, Cluj-Napoca, Constanta, Jassi, and Timișoara, RomaniaSee the 6 sitesAlso in 4 other countries, 21 sites
- Trial code
- Registry title
- Study of an Injectable Regimen of GS-3242 with Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 185 people, planned
- Started
- 28 Oct 2026
- Expected to end
- 4 Apr 2033
- Type of study
- Interventional
- Record updated
- 21 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with HIV-1 who have never taken HIV treatment. It compares an injectable GS-3242 plus lenacapavir with Biktarvy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- HIV-1 with a viral load (HIV-1 RNA) of 500 copies/mL or more at screening
- Earlier treatment
- Never taken HIV (ARV) treatment. Daily PrEP or PEP pills up to 1 month before screening are allowed.
- Biomarker or test result
- HIV-1 RNA of 500 copies/mL or more at screening
Main reasons for not taking part
- Has used or been exposed to lenacapavir (LEN) or GS-3242
- Has used a long-acting injectable HIV medicine, such as injectable cabotegravir or injectable rilpivirine
- Has used HIV antibodies (monoclonal or broadly neutralizing) as treatment
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Romania
Also in 4 other countries, 21 sites
- Spitalul Clinic De Urgenta Prof Dr Agrippa IonescuBaloteşti, RomaniaNot yet recruiting
- Institutul National de Boli Infectioase "Prof.Dr. Matei Bals"Bucharest, RomaniaNot yet recruiting
- Spitalul Clinic De Boli Infectioase Cluj-NapocaCluj-Napoca, RomaniaNot yet recruiting
- Spitalul Clinic De Boli Infectioase ConstantaConstanta, RomaniaNot yet recruiting
- Spitalul Clinic De Boli Infectioase Sf. Parascheva IasiJassi, RomaniaNot yet recruiting
- Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș TimișoaraTimișoara, RomaniaNot yet recruiting
About the trial
What the trial wants to find out
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
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- GS-3242 with lenacapavir injections compared to Biktarvy in adults starting HIV-1 treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 21 October 2026