Pilot Trial of the Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection — VORVAX  

HIV-1 Infection Clinical Trial

Official title: IGHID 11424 - A Pilot Trial of the Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection (The VOR VAX Study)

Status Terminated

Clinical Trial Summary

The purpose of this research study is to 1) evaluate the safety of a series of injections with the AGS-004 product in combination with a series of Vorinostat doses and 2) to help scientists evaluate ways of reactivating latent (non-acting) HIV virus and determine if the immune system can be made stronger to eliminate the activated HIV virus.

Clinical Trial Description

Purpose: Phase I study to measure the potential of AGS-004 combined with Vorinostat to: 1) stimulate expression of persistent proviral HIV from resting CD4+ cells, 2) generate an HIV-specific immune response, and 3) when combined, clear persistent infection in HIV-infected participants in whom viral replication and spread is inhibited by uninterrupted antiretroviral therapy (ART).

This is a phase I, single-site, pilot study intended to evaluate the association of serial AGS-004 vaccinations in combination with serial VOR doses on the expression of persistent proviral HIV, HIV-specific immune responses, and the frequency of resting CD4+T cell infection. Twelve participants with durable viral suppression will be enrolled. All participants will receive the same treatment and doses of AGS-004 and VOR and continue their baseline ART regimen throughout the study. ;

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• HIV-1 Infection
• Infection

• NCT number: NCT02707900
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Terminated
• Phase: Phase 1
• Start date: March 2016
• Completion date: July 11, 2018