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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 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 15 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03803605
The ClinicalTrials.gov registry entry for NCT03803605 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which VRC07-523LS is the first listed.
NCT03803605 reports 0 study locations.
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.
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