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NCT06630286 · ClinicalTrials.gov registry record · Phase 3
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
A Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 3
- Development phase
- 609
- Enrollment target
- 20
- Study locations
NCT06630286: Active Phase 3 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT06630286 is a Phase 3 study of HIV-1-infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 609 participants, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (78% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06630286, a Phase 3 study of HIV-1-infection, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 609 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.
Conditions Studied
Interventions
- DRUG B/F/TAF
- DRUG ISL/LEN
- DRUG PTM B/F/TAF
- DRUG PTM ISL/LEN
Study Locations (20)
Florida
- CAN Community Health - Fort Lauderdale
- Midway Immunology and Research Center - Ft. Pierce
- CAN Community Health - Miami Gardens
- Midland Research Group, Inc. - Oakland Park
- Orlando Immunology Center - Orlando
- AHF (AIDS Healthcare Foundation) - Pensacola Research - Pensacola
- CAN Community Health - Sarasota
- St. Josephs Comprehensive Research Institute - Tampa
California
- Kaiser Permanente Southern California - Los Angeles
- Ruane Clinical Research Group, Inc - Los Angeles
- Mills Clinical Research - Los Angeles
- BIOS Clinical Research - Palm Springs
- Optimus Medical Group - San Francisco
Colorado
- Vivent Health - Denver
- University of Colorado- Anschutz Medical Campus - PPDS - Denver
District of Columbia
- Georgetown University - Washington D.C.
- Whitman-Walker Health - Washington D.C.
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Pueblo Family Physicians - Phoenix
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 609 participants |
| Start Date | 2024-10-09 |
| Est. Completion | 2030-08 |
| Phase | Phase 3 |
What the registry record for NCT06630286 still lists
NCT06630286 is an interventional study that assigns participants to a tested intervention. The registered 609 participants enrollment target is mid-sized for trials with a published cap, above the 343-participant average among 71 other HIV-1-infection trials with a reported enrollment target (78% higher).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 4 interventions - of which B/F/TAF is the first listed.
NCT06630286 names 20 study sites across 7 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06630286 about?
NCT06630286 is a clinical study titled "Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1". The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH)...
What is the current status of trial NCT06630286?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 609 participants. The study started on 2024-10-09. Estimated completion is 2030-08.
What conditions does trial NCT06630286 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT06630286?
The interventions under investigation include: B/F/TAF (DRUG), ISL/LEN (DRUG), PTM B/F/TAF (DRUG), PTM ISL/LEN (DRUG).
Who is sponsoring clinical trial NCT06630286?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06630286 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV-1-infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06630286's enrollment target sits among peer trials
609 8th of 71 higher than 64 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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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A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)
ACTIVE NOT RECRUITING · Phase 3
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Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
ACTIVE NOT RECRUITING · Phase 3
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