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NCT02256631 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
- 14
- Study locations
NCT02256631: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02256631 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 83 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (81% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02256631, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
Primary Outcome
The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Deaths from day 0 to 4 weeks after the participants' last immunization were included.
Conditions Studied
Interventions
- BIOLOGICAL VRC07-523LS
- BIOLOGICAL VRC01
- BIOLOGICAL VRC01LS
Study Locations (14)
Florida
- South Florida CDTC Ft Lauderdale NICHD CRS - Fort Lauderdale
- Univ. of Florida Jacksonville NICHD CRS - Jacksonville
- Pediatric Perinatal HIV Clinical Trials Unit CRS - Miami
New York
- Bronx-Lebanon Hospital Center NICHD CRS - The Bronx
- Jacobi Med. Ctr. Bronx NICHD CRS - The Bronx
Other
- University of Puerto Rico Pediatric HIV/AIDS Research Program CRS - San Juan
- Harare Family Care CRS - Harare
California
- David Geffen School of Medicine at UCLA NICHD CRS - Los Angeles
Colorado
- Univ. of Colorado Denver NICHD CRS - Aurora
Georgia
- Emory University School of Medicine NICHD CRS - Atlanta
Maryland
- Johns Hopkins Univ. Baltimore NICHD CRS - Baltimore
Texas
- Texas Children's Hospital CRS - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2015-06-30 |
| Est. Completion | 2021-12-16 |
| Phase | Phase 1 |
What the finished NCT02256631 record still lists
NCT02256631 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 446-participant average among 542 other HIV Infections trials with a reported enrollment target (81% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which VRC07-523LS is the first listed.
NCT02256631 lists 14 locations in 10 states (Florida, New York, Other).
Frequently Asked Questions
What is clinical trial NCT02256631 about?
NCT02256631 is a clinical study titled "Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants". The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
What is the current status of trial NCT02256631?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2015-06-30. Estimated completion is 2021-12-16.
What conditions does trial NCT02256631 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT02256631?
The interventions under investigation include: VRC07-523LS (BIOLOGICAL), VRC01 (BIOLOGICAL), VRC01LS (BIOLOGICAL).
Who is sponsoring clinical trial NCT02256631?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02256631 being conducted?
This trial has 14 study locations across California, Colorado, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02256631's enrollment target sits among peer trials
83 297th of 542 higher than 245 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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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