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NCT03739996 · ClinicalTrials.gov registry record · Phase 2
Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT03739996: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03739996 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03739996, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
The purpose of this study was to assess the safety, tolerability, antiviral activity, and pharmacokinetics of long-acting cabotegravir (CAB LA) plus the broadly neutralizing monoclonal antibody VRC-HIVMAB075-00-AB (VRC07-523LS), in adults living with HIV-1 with suppressed plasma viremia.
Primary Outcome
The proportion of participants reporting a grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event OR premature discontinuation due to an adverse event (regardless of grade) that the clinical management committee judged to be at least possibly related to the CAB LA plus VRC07-523LS combination. Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017
Interventions
- BIOLOGICAL VRC07-523LS
- DRUG Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
- DRUG Oral Cabotegravir (CAB)
- DRUG Long-Acting Injectable Cabotegravir (CAB LA)
- DRUG Standard of Care (SOC) ART
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2019-12-31 |
| Est. Completion | 2024-04-29 |
| Phase | Phase 2 |
What the finished NCT03739996 record still lists
NCT03739996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 5 interventions - of which VRC07-523LS is the first listed.
NCT03739996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03739996 about?
NCT03739996 is a clinical study titled "Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1". The purpose of this study was to assess the safety, tolerability, antiviral activity, and pharmacokinetics of long-acting cabotegravir (CAB LA) plus the broadly neutralizing monoclonal antibody VRC-HIVMAB075-00-AB (VRC07-523LS), in adults living with HIV-1 with suppressed plasma viremia.
What is the current status of trial NCT03739996?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2019-12-31. Estimated completion is 2024-04-29.
What interventions are being tested in trial NCT03739996?
The interventions under investigation include: VRC07-523LS (BIOLOGICAL), Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (DRUG), Oral Cabotegravir (CAB) (DRUG), Long-Acting Injectable Cabotegravir (CAB LA) (DRUG), Standard of Care (SOC) ART (DRUG).
Who is sponsoring clinical trial NCT03739996?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03739996's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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