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NCT03803605 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03803605: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT03803605 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03803605, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Adult participants (18-64 years old) with HIV-1 Infection on ART with a CD4 T cell count ≥ 350 cells/mm3 and viral suppression for ≥ 24 months will be enrolled on this study. Participants will receive two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-AB (VRC07-523LS) followed by 10 oral (PO) doses of Vorinostat (VOR) taken every 72 hours. Each series will last approximately 1 month and the two series will be separated by at least one month. Combination ART is maintained throughout the study. Participants will be on this study for approximately 28 weeks (or about 7 months). The purpose of this study is to: * Evaluate the safety of two series of a VRC07-523LS infusion followed by multiple oral doses of VOR * Determine if combining VRC07-523LS and VOR can have an impact on non-active HIV virus.
Primary Outcome
The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 was used to measure safety where Grade 3 is defined as severe and Grade 4 is defined as potentially life-threatening. Treatment-Related AEs assessments are considered related to study product as possible, probable, or definite as defined in the protocol.
Interventions
- BIOLOGICAL VRC07-523LS
- DRUG Vorinostat (VOR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-02-12 |
| Est. Completion | 2021-01-28 |
| Phase | Phase 1 |
What the finished NCT03803605 record still lists
NCT03803605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which VRC07-523LS is the first listed.
NCT03803605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03803605 about?
NCT03803605 is a clinical study titled "Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons". Adult participants (18-64 years old) with HIV-1 Infection on ART with a CD4 T cell count ≥ 350 cells/mm3 and viral suppression for ≥ 24 months will be enrolled on this study. Participants will receive two series of combination therapy consisting of one (1) intravenous (IV) dose of VRC-HIVMAB075-00-A...
What is the current status of trial NCT03803605?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-02-12. Estimated completion is 2021-01-28.
What interventions are being tested in trial NCT03803605?
The interventions under investigation include: VRC07-523LS (BIOLOGICAL), Vorinostat (VOR) (DRUG).
Who is sponsoring clinical trial NCT03803605?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03803605's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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