2026-526026-40-00RecruitingPhase 2/3
Study of an Injectable Regimen of GS-3242 with Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
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: EU CTIS (euclinicaltrials.eu) · Last updated 21 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 185 (estimated)
- First submitted
- 29 Jun 2026
- Start date
- 28 Oct 2026
- Lead sponsor
- Gilead Sciences Inc.
- Diseases
- HIV
- EU CT number
- 2026-526026-40-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 185
- 27 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Bonn AöR | Bonn | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Recruiting |
| Infektio Research GmbH & Co. KG | Frankfurt Am Main | Germany | Recruiting |
| ICH Study Center Gmbh & Co. KG | Hamburg | Germany | Recruiting |
| Medizinische Hochschule Hannover | Hanover | Germany | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Universitario Virgen de las Nieves | Granada | Spain | Recruiting |
| Bellvitge University Hospital | L'hospitalet De Llobregat | Spain | Recruiting |
| Hospital Universitario Infanta Leonor | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Recruiting |
| Wojewodzki Szpital Obserwacyjno-Zakazny Im Tadeusza Browicza | Bydgoszcz | Poland | Not yet recruiting |
| Punkt Zdrowia Hlebowicz Jakubowski Lekarze sp. p. | Gdansk | Poland | Not yet recruiting |
| Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie | Szczecin | Poland | Not yet recruiting |
| Wroclawskie Centrum Zdrowia Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Wroclaw | Poland | Not yet recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. | Almada | Portugal | Not yet recruiting |
| Unidade Local De Saude De Amadora Sintra E.P.E. | Amadora | Portugal | Not yet recruiting |
| Unidade Local De Saude De Lisboa Ocidental E.P.E. | Lisbon | Portugal | Not yet recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. | Lisbon | Portugal | Not yet recruiting |
| Unidade Local De Saude De Santo Antonio E.P.E. | Porto | Portugal | Not yet recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. | Porto | Portugal | Not yet recruiting |
| Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu | Baloteşti | Romania | Not yet recruiting |
| Institutul National de Boli Infectioase "Prof.Dr. Matei Bals" | Bucharest | Romania | Not yet recruiting |
| Spitalul Clinic De Boli Infectioase Cluj-Napoca | Cluj-Napoca | Romania | Not yet recruiting |
| Spitalul Clinic De Boli Infectioase Constanta | Constanta | Romania | Not yet recruiting |
| Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi | Jassi | Romania | Not yet recruiting |
| Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara | Timișoara | Romania | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.