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NCT02471326 · ClinicalTrials.gov registry record · Phase 1
VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02471326: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02471326 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02471326, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: \- A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV) very low for a long time. But cART can lose effectiveness and cause permanent side effects. If treatment stops, HIV levels go up again. Researchers want to see if a new product can control HIV levels when a person is off cART. Objective: \- To see if the new product VRC01 is safe and can control the HIV level in the blood when a person is not taking cART. Eligibility: \- Adults ages 18-65 with HIV who are willing to interrupt their treatment for at least 24 weeks. Design: * Participants will be screened with: * Physical exam * Medical history * Heart tests * Blood and urine tests. * Their HIV drugs may be switched. They will keep taking them until a few days after Visit 1. * Visit 1: Repeat screening procedures. * Participants will also have genetic testing and leukapheresis. For this, blood will be removed through a needle in one arm and circulated through a machine that removes white blood cells. The rest of the blood is returned through a needle in the other arm. * They will get the first study drug dose through a thin tube in an arm vein for about 1 hour. * For 24 weeks, participants will have 16 visits. They will have blood drawn every visit. At some visits they will repeat the screening procedures and get another VRC01 dose. They may have another leukapheresis. * Four weeks after the last dose, participants will restart their cART. For 20 weeks, they will have monthly visits to repeat the screening procedures and discuss new symptoms.
Primary Outcome
The primary endpoint was the number of grade 3 or higher adverse events, including serious adverse events, that were possibly related to VRC-HIVMAB060-00-AB (VRCO1).
Interventions
- BIOLOGICAL VRC-HIVMAB060-00-AB (VRC01)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-07-13 |
| Est. Completion | 2017-04-07 |
| Phase | Phase 1 |
What the finished NCT02471326 record still lists
NCT02471326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which VRC-HIVMAB060-00-AB (VRC01) is the first listed.
NCT02471326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02471326 about?
NCT02471326 is a clinical study titled "VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption". Background: \- A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV) very low for a long time. But cART can lose effectiveness and cause permanent side effects. If treatment stops, HIV levels go up again. Researchers want to see if a new product can control HIV leve...
What is the current status of trial NCT02471326?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2015-07-13. Estimated completion is 2017-04-07.
What interventions are being tested in trial NCT02471326?
The interventions under investigation include: VRC-HIVMAB060-00-AB (VRC01) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02471326?
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 NCT02471326's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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