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Clinical Trial Active — Not Recruiting Phase III NCT06333808

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy — Active Not Recruiting • Phase III • Infectious Disease •…

📅 15 Jun 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT06333808
Start
2024-03-25
Completion
2025-10-27
ClinicaliQ Trial Snapshot
  • Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy — Active Not Recruiting • Phase III • Infectious Disease • NCT06333808.
  • Trial comparing a new two-drug HIV combination against standard three-drug treatment in people with well-controlled infection.

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What This Trial Is Studying

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH. Conditions: HIV-1-infection Interventions: Bictegravir, Lenacapavir, B/F/TAF, Placebo to match B/F/TAF, Placebo to match BIC/LEN Lead Sponsor: Gilead Sciences Planned Enrollment: 577 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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