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NCT01319383 · ClinicalTrials.gov registry record · Phase 1
The Effect of Vorinostat on HIV RNA Expression in the Resting CD4+ T Cells of HIV+ Pts on Stable ART
A Phase 1 study of HIV-1-infection, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT01319383: Completed Phase 1 study of HIV-1-infection, sponsored by University of North Carolina, Chapel Hill.
NCT01319383 is a Phase 1 study of HIV-1-infection that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 25 participants, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01319383, a Phase 1 study of HIV-1-infection, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare HIV RNA expression and infection within resting (CD4)+ cells in HIV-infected patients on stable ART before and after a single exposure to Vorinostat (VOR), after exposure to short intervals of VOR, and after repeated short interval exposure to VOR dosed over several weeks. Hypotheses: 1. The frequency of resting CD4+ T cell- associated HIV RNA (RCVL) will be increased following single and repeated exposure to VOR when given at appropriate intervals, and 2. That repeated exposure to VOR will reduce the frequency of HIV infection within resting CD4+ T cells (RCI)
Primary Outcome
Participants in Arm 1 and 2 were analyzed in Step 2 for an in vivo increase in resting CD4+ T cell- associated HIV RNA (RCVL) after administration of a single dose of VOR 400 mg PO
Conditions Studied
Interventions
- DRUG Vorinostat
Study Locations (1)
North Carolina
- The University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-02 |
| Est. Completion | 2016-03-31 |
| Phase | Phase 1 |
What the finished NCT01319383 record still lists
NCT01319383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 351-participant average among 71 other HIV-1-infection trials with a reported enrollment target (93% lower).
The record links to 1 condition, with HIV-1-infection appearing as the primary indexed condition, and to 1 intervention - of which Vorinostat is the first listed.
NCT01319383 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01319383 about?
NCT01319383 is a clinical study titled "The Effect of Vorinostat on HIV RNA Expression in the Resting CD4+ T Cells of HIV+ Pts on Stable ART". The purpose of this study is to compare HIV RNA expression and infection within resting (CD4)+ cells in HIV-infected patients on stable ART before and after a single exposure to Vorinostat (VOR), after exposure to short intervals of VOR, and after repeated short interval exposure to VOR dosed over s...
What is the current status of trial NCT01319383?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2011-02. Estimated completion is 2016-03-31.
What conditions does trial NCT01319383 study?
This clinical trial studies the following conditions: HIV-1-infection.
What interventions are being tested in trial NCT01319383?
The interventions under investigation include: Vorinostat (DRUG).
Who is sponsoring clinical trial NCT01319383?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01319383 being conducted?
This trial has 1 study location across North Carolina. 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 NCT01319383's enrollment target sits among peer trials
25 61st of 71 higher than 9 of 71 other HIV-1-infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV-1-infection 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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