Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
Public ClinicalTrials.gov record NCT07708727. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07708727
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 700 participants
Conditions and interventions
Conditions
Interventions
- GS-3242 Tablet Drug
- GS-3242 Injection Drug
- Lenacapavir Tablet Drug
- Lenacapavir Injection Drug
- B/F/TAF Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 29, 2026 (Actual)
- Primary completion
- Oct 2030 (Estimated)
- Completion
- Apr 2033 (Estimated)
- Last update posted
- Oct 13, 2026
2026 – 2033
United States locations
- U.S. sites
- 12
- U.S. states
- 6
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lundquist Inst Biomedical Innovation Harbor-UCLA | Torrance | California | 90502 | Recruiting |
| Yale University; School of Medicine; AIDS Program | New Haven | Connecticut | 06510 | Recruiting |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | Recruiting |
| Orlando Immunology Center, PA | Orlando | Florida | 32803 | Recruiting |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | 33401 | Recruiting |
| Emory University Hospital Midtown Infectious Disease Clinic | Atlanta | Georgia | 30308 | Recruiting |
| Metro Infectious Disease Consultants, P.L.L.C | Decatur | Georgia | 30033 | Recruiting |
| KC care Health Center | Kansas City | Missouri | 64111 | Recruiting |
| St Hope Foundation, Inc, | Bellaire | Texas | 77401 | Recruiting |
| Prism Health North Texas | Dallas | Texas | 75208 | Recruiting |
| North Texas Infectious Diseases Consultants, PA | Dallas | Texas | 75246 | Recruiting |
| Texas Centers for Infectious Disease Associates | Fort Worth | Texas | 76109 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07708727, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07708727 live on ClinicalTrials.gov.