NCT07645287 A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
| NCT ID | NCT07645287 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Gilead Sciences |
| Condition | HIV-1-infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 175 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 175 participants in total. It began in 2026-06-15 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26. The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.
Eligibility Criteria
Key Inclusion Criteria: * Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL for ≥ 6 months before screening. * Plasma HIV-1 RNA levels \< 50 copies/mL at screening. * Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening. * No documented resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S). Key Exclusion Criteria: * Prior use of, or exposure to GS-3242 or LEN. * History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen. * Prior use of any long-acting parenteral antiretroviral 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.
Contact & Investigator
Gilead Clinical Study Information Center
✉ GileadClinicalTrials@gilead.com📞 1-833-445-3230 (GILEAD-0)
Gilead Study Director
STUDY DIRECTOR
Gilead Sciences
Frequently Asked Questions
Who can join the NCT07645287 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07645287 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07645287 currently recruiting?
Yes, NCT07645287 is actively recruiting participants. Contact the research team at GileadClinicalTrials@gilead.com for enrollment information.
Where is the NCT07645287 trial being conducted?
This trial is being conducted at Phoenix, United States, Beverly Hills, United States, Los Angeles, United States, San Francisco, United States and 11 additional locations.
Who is sponsoring the NCT07645287 clinical trial?
NCT07645287 is sponsored by Gilead Sciences. The principal investigator is Gilead Study Director at Gilead Sciences. The trial plans to enroll 175 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.