Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05729568 · ClinicalTrials.gov registry record · Phase 2
A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
A Phase 2 study of HIV Infection, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
- 20
- Study locations
NCT05729568: Active Phase 2 study of HIV Infection, sponsored by Gilead Sciences.
NCT05729568 is a Phase 2 study of HIV Infection that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 83 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05729568, a Phase 2 study of HIV Infection, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection. The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, TAB and ZAB, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.
Primary Outcome
Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study d
Conditions Studied
Interventions
- DRUG Lenacapavir Injection
- DRUG Lenacapavir Tablet
- DRUG Teropavimab
- DRUG Zinlirvimab
- DRUG Antiretroviral Therapy
Study Locations (20)
Florida
- Midland Florida Clinical Research Center, LLC - DeLand
- Can Community Health Care - Fort Lauderdale
- Midway Immunology and Research Center - Ft. Pierce
- Orlando Immunology Center - Orlando
- Triple O Research Institute, P.A. - West Palm Beach
California
- Ruane Clinical Research Group, Inc. - Los Angeles
- Mills Clinical Research - Los Angeles
- UC San Diego (UCSD) AntiViral Research Center (AVRC) - San Diego
- Optimus Medical Group - San Francisco
North Carolina
- NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill - Chapel Hill
- Duke University Health Center - Durham
- Regional Center for Infectious Disease Research - Greensboro
Georgia
- Emory University Hospital Midtown Infectious Disease Clinic - Atlanta
- Infectious Disease Specialists of Atlanta - Decatur
Colorado
- University of Colorado Clinical and Translational Research Center - Aurora
Connecticut
- Yale University; School of Medicine; AIDS Program - New Haven
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Missouri
- Southhampton Healthcare, Inc - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
What the registry record for NCT05729568 still lists
NCT05729568 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (66% lower).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 5 interventions - of which Lenacapavir Injection is the first listed.
NCT05729568 names 20 study sites across 10 states, led by Florida, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05729568 about?
NCT05729568 is a clinical study titled "A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection". The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection. The purpose of this...
What is the current status of trial NCT05729568?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2023-05-15. Estimated completion is 2029-12.
What conditions does trial NCT05729568 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT05729568?
The interventions under investigation include: Lenacapavir Injection (DRUG), Lenacapavir Tablet (DRUG), Teropavimab (DRUG), Zinlirvimab (DRUG), Antiretroviral Therapy (DRUG).
Who is sponsoring clinical trial NCT05729568?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05729568 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV 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 NCT05729568's enrollment target sits among peer trials
83 29th of 73 higher than 45 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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
-
Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer
RECRUITING · Phase 2
-
Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV Infection
ACTIVE NOT RECRUITING · Phase 2
-
The Role of Ampligen in Strategic Therapeutic Intervention (STI) of HAART
COMPLETED · Phase 2
-
Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women
COMPLETED · Phase 2
-
Thalidomide to Treat Oral Lesions in HIV-Infected Patients
COMPLETED · Phase 2
-
A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
COMPLETED · 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
- NCT02974647 · 83 participants · Phase 2
Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
- NCT03919292 · 83 participants · Phase 1
Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
- NCT04626674 · 83 participants · Phase 1
A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
- NCT05277168 · 83 participants · Phase 1
A Trial TO Evaluate THE Safety, Tolerability, Pharmacokinetics, AND Efficacy OF Shr-a1904 IN Subjects With Advanced Solid Tumors
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