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NCT06544733 · ClinicalTrials.gov registry record · Phase 2
Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
A Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 2
- Development phase
- 675
- Enrollment target
- 20
- Study locations
NCT06544733: Active Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT06544733 is a Phase 2 study of HIV-1-infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 675 participants, above the 342-participant average among 71 other HIV-1-infection trials with a reported enrollment target (97% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06544733, a Phase 2 study of HIV-1-infection, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 675 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical study is to learn more about the experimental drugs GS-1720 and GS-4182; to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the combination of GS-1720 and GS-4182 is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection. This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of switching to oral weekly GS-1720 in combination with GS-4182 versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24. Phase 3: To evaluate the efficacy of switching to oral weekly GS-1720/GS-4182 Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.
Conditions Studied
Interventions
- DRUG GS-1720
- DRUG GS-4182
- DRUG Bictegravir/emtricitabine/tenofovir alafenamide
- DRUG GS-1720/GS-4182 FDC
- DRUG Placebo to Match BVY
Study Locations (20)
Florida
- Midland Florida Clinical Research Center, LLC - DeLand
- CAN Community Health - Fort Lauderdale
- Midway and Immunology Research Center - Ft. Pierce
- AIDS Healthcare Foundation - The Kinder Medical Group - Miami
- Floridian Clinical Research - Miami Lakes
- Orlando Immunology Center - Orlando
- CAN Community Health - Sarasota
- Triple O Research Institute, P.A. - West Palm Beach
California
- Pacific Oaks Medical Group - Beverly Hills
- Ruane Clinical Research Group - Los Angeles
- Mills Clinical Research - Los Angeles
- BIOS Clinical Research - Palm Springs
- UCSF Division of HIV, Infectious Diseases & Global Medicine - San Francisco
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Georgia
- Metro Infectious Disease Consultants, P.L.L.C. - Decatur
- Mercer University, Department of Internal Medicine - Macon
- Chatham County Health Department - Savannah
Alabama
- UAB 1917 Research Clinic - Birmingham
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Michigan
- Be Well Medical Center - Berkley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2024-08-20 |
| Est. Completion | 2029-06 |
| Phase | Phase 2 |
What the registry record for NCT06544733 still lists
NCT06544733 is an interventional study that assigns participants to a tested intervention. The registered 675 participants enrollment target is mid-sized for trials with a published cap, above the 342-participant average among 71 other HIV-1-infection trials with a reported enrollment target (97% higher).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 5 interventions - of which GS-1720 is the first listed.
NCT06544733 names 20 study sites across 6 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06544733 about?
NCT06544733 is a clinical study titled "Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed". The goal of this clinical study is to learn more about the experimental drugs GS-1720 and GS-4182; to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), to see if the combination of GS-1720 and GS...
What is the current status of trial NCT06544733?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 675 participants. The study started on 2024-08-20. Estimated completion is 2029-06.
What conditions does trial NCT06544733 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT06544733?
The interventions under investigation include: GS-1720 (DRUG), GS-4182 (DRUG), Bictegravir/emtricitabine/tenofovir alafenamide (DRUG), GS-1720/GS-4182 FDC (DRUG), Placebo to Match BVY (DRUG).
Who is sponsoring clinical trial NCT06544733?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06544733 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06544733's enrollment target sits among peer trials
675 5th of 71 higher than 66 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.
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