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NCT07645287 · ClinicalTrials.gov registry record · Phase 2
A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
A Phase 2 study, sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
NCT07645287: Recruiting Phase 2 study, sponsored by Gilead Sciences.
NCT07645287 is a Phase 2 study that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 175 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07645287, a Phase 2 study, is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 175 participants
- Enrollment target
Study 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.
Interventions
- DRUG B/F/TAF
- DRUG Lenacapavir Injection
- DRUG Lenacapavir Tablet
- DRUG GS-3242 Tablet
- DRUG GS-3242 Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2026-06-15 |
| Est. Completion | 2033-04 |
| Phase | Phase 2 |
What NCT07645287 shows while recruiting
NCT07645287 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 5 interventions - of which B/F/TAF is the first listed.
NCT07645287 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07645287 about?
NCT07645287 is a clinical study titled "A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1". 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...
What is the current status of trial NCT07645287?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2026-06-15. Estimated completion is 2033-04.
What interventions are being tested in trial NCT07645287?
The interventions under investigation include: B/F/TAF (DRUG), Lenacapavir Injection (DRUG), Lenacapavir Tablet (DRUG), GS-3242 Tablet (DRUG), GS-3242 Injection (DRUG).
Who is sponsoring clinical trial NCT07645287?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07645287's enrollment target sits among peer trials
175 396th of 2000 higher than 1,605 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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