Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons
Status:
Completed
Trial end date:
2021-01-28
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)