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NCT02716675 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 2,699
- Enrollment target
NCT02716675: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02716675 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 2,699 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1929% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02716675, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,699 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG) persons who have sex with men, in North America, South America, and Switzerland.
Primary Outcome
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Interventions
- BIOLOGICAL VRC01
- BIOLOGICAL Placebo for VRC01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,699 participants |
| Start Date | 2016-04-06 |
| Est. Completion | 2020-12-01 |
| Phase | Phase 2 |
What the finished NCT02716675 record still lists
NCT02716675 is an interventional study that assigns participants to a tested intervention. Its 2,699 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1929% higher).
The record links to 0 conditions, and to 2 interventions - of which VRC01 is the first listed.
NCT02716675 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02716675 about?
NCT02716675 is a clinical study titled "Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men". This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG) persons who have sex with men, in North America, South America, and Switzerland.
What is the current status of trial NCT02716675?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,699 participants. The study started on 2016-04-06. Estimated completion is 2020-12-01.
What interventions are being tested in trial NCT02716675?
The interventions under investigation include: VRC01 (BIOLOGICAL), Placebo for VRC01 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02716675?
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 NCT02716675's enrollment target sits among peer trials
2,699 7th of 2000 higher than 1,994 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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