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NCT02165267 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Safety and Drug Levels of an Antibody Against HIV in Healthy, HIV-Uninfected Adults
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
- 6
- Study locations
NCT02165267: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02165267 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 88 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (80% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02165267, 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
- 88 participants
- Enrollment target
- 6
- Study locations
Study Summary
Antibodies are natural proteins that the body makes to fight infections. Antibodies can also be manufactured like a drug and infused or injected into the body to prevent or treat a disease. The purpose of this study is to test the safety of and the body's response to an antibody against HIV in healthy, HIV-uninfected adults.
Primary Outcome
Assessment occurs at each product administration and for 3 days after administration.
Conditions Studied
Interventions
- BIOLOGICAL VRC01
- BIOLOGICAL SC placebo for VRC01
- BIOLOGICAL IV placebo for VRC01
Study Locations (6)
Massachusetts
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS) - Boston
- Fenway Health (FH) CRS - Boston
New York
- Columbia P&S CRS - New York
- New York Blood Center CRS - New York
Ohio
- Case Clinical Research Site - Cleveland
Pennsylvania
- Penn Prevention CRS - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2014-08 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT02165267 record still lists
NCT02165267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (80% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which VRC01 is the first listed.
NCT02165267 lists 6 locations in 4 states (Massachusetts, New York, Ohio).
Frequently Asked Questions
What is clinical trial NCT02165267 about?
NCT02165267 is a clinical study titled "Evaluating the Safety and Drug Levels of an Antibody Against HIV in Healthy, HIV-Uninfected Adults". Antibodies are natural proteins that the body makes to fight infections. Antibodies can also be manufactured like a drug and infused or injected into the body to prevent or treat a disease. The purpose of this study is to test the safety of and the body's response to an antibody against HIV in healt...
What is the current status of trial NCT02165267?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2014-08. Estimated completion is 2016-02.
What conditions does trial NCT02165267 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT02165267?
The interventions under investigation include: VRC01 (BIOLOGICAL), SC placebo for VRC01 (BIOLOGICAL), IV placebo for VRC01 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02165267?
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 NCT02165267 being conducted?
This trial has 6 study locations across Massachusetts, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
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 NCT02165267's enrollment target sits among peer trials
88 293rd of 542 higher than 250 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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