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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 is a Phase 2 study that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 175 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07645287
The ClinicalTrials.gov registry entry for NCT07645287 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which B/F/TAF is the first listed.
NCT07645287 reports 0 study locations.
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.
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