Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons

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.

Timeline

Start

2019-02-12

Primary completion

2021-01-28

Completion

2021-01-28

Publications

• Gay CL, James KS, Tuyishime M, Falcinelli SD, Joseph SB, Moeser MJ, Allard B, Kirchherr JL, Clohosey M, Raines SLM, Montefiori DC, Shen X, Gorelick RJ, Gama L, McDermott AB, Koup RA, Mascola JR, Floris-Moore M, Kuruc JD, Ferrari G, Eron JJ, Archin NM, Margolis DM. Stable Latent HIV Infection and Low-level Viremia Despite Treatment With the Broadly Neutralizing Antibody VRC07-523LS and the Latency Reversal Agent Vorinostat. J Infect Dis. 2022 Mar 2;225(5):856-861. doi: 10.1093/infdis/jiab487.
• Day S, Mathews A, Blumberg M, Vu T, Rennie S, Tucker JD. Broadening community engagement in clinical research: Designing and assessing a pilot crowdsourcing project to obtain community feedback on an HIV clinical trial. Clin Trials. 2020 Jun;17(3):306-313. doi: 10.1177/1740774520902741. Epub 2020 Feb 3.

Drugs

Indications