Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06613685 · ClinicalTrials.gov registry record · Phase 2
Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
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
NCT06613685: Active Phase 2 study of HIV-1-infection, sponsored by Gilead Sciences.
NCT06613685 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 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06613685, 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 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), 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 in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly GS-1720 coadministered with GS-4182 versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive 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
- Midway Immunology and Research Center - Ft. Pierce
- Floridian Clinical Research, LLC - Miami Lakes
- Orlando Immunology Center - Orlando
- Triple O Research Institute, P.A. - West Palm Beach
Texas
- St Hope Foundation, Inc. - Bellaire
- Prism Health North Texas, Aids Arms - Dallas
- North Texas Infectious Diseases Consultants, PA - Dallas
- Texas Centers for Infectious Disease Associates - Fort Worth
- UT Health San Antonio - San Antonio
California
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
- Mills Clinical Research - West Hollywood
Georgia
- Emory University Hospital Midtown Infectious Disease Clinic - Atlanta
- Mercer University, Department of Internal Medicine - Macon
Alabama
- UAB 1917 Research Clinic - Birmingham
District of Columbia
- Georgetown University Medical School - Washington D.C.
Mississippi
- University of Mississippi Medical Center - Jackson
New Jersey
- Saint Michael's Medical Center - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2024-10-21 |
| Est. Completion | 2030-08 |
| Phase | Phase 2 |
What the registry record for NCT06613685 still lists
NCT06613685 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.
NCT06613685 names 20 study sites across 10 states, led by Florida, Texas, California.
Frequently Asked Questions
What is clinical trial NCT06613685 about?
NCT06613685 is a clinical study titled "Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated". The goal of this clinical study is to learn more about the experimental drugs GS-1720 (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and GS-4182 (a prodrug of Lenacapavir (LEN)); to compare the combination of GS-1720 and GS-4182 with the current standard-of-care treatment bictegr...
What is the current status of trial NCT06613685?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 675 participants. The study started on 2024-10-21. Estimated completion is 2030-08.
What conditions does trial NCT06613685 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT06613685?
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 NCT06613685?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06613685 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
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 NCT06613685'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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Improving Coronary Vascular Health in Women
RECRUITING · Phase 2
-
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
RECRUITING · Phase 2
-
PrEPsmart 2-1-1 Pilot
RECRUITING · Phase 2
-
A Clinical Trial of STP0404 in Adults With HIV-1 Infection
RECRUITING · Phase 2
-
Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1
RECRUITING · Phase 2
-
Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04788277 · 675 participants
Investigation Into Detection of Prostate Cancer Using Voided Urine (Prostate VPAC)
- NCT05356234 · 675 participants · NA
Ignite Study of the Jewish Family and Children's Service of the Suncoast, Inc.
- NCT06070870 · 675 participants · NA
Health Education Approach to Lung Screening
- NCT06357533 · 675 participants · Phase 3
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI