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Safety and Immunogenicity of HIVAX in HIV-1 Infected Subjects — GCHT01  

HIV Infections Clinical Trial

Official title:
A Phase I Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Replication-defective HIV-1 Vaccine (HIVAX™) in HIV-1 Infected Subjects Receiving Highly Active Antiretroviral Therapy

Clinical Trial Summary

This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The safety and immune responses will be studied in vaccine recipients. The anti-viral effect of HIVAX vaccine will be monitored during a 12-week treatment interruption phase.

Clinical Trial Description

This is a randomized, placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of two doses of a replication defective HIV-1 vaccine (HIVAX™) in subjects receiving stable highly active antiretroviral therapy (HAART) who have an HIV-1 RNA <50 copies/ml and CD4 cell count >500 cells/mm3. Following the randomized placebo-controlled vaccination phase subjects who received active vaccine and who meet eligibility will undergo a 12-week analytical antiretroviral treatment interruption followed by reinstitution of antiretroviral therapy (or continued interruption) with follow up through week 48. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01428596
Study type Interventional
Source GeneCure Biotechnologies
Contact Margaret A. Fischl, MD
Phone 305-243-3847
Email mfischl@med.miami.edu
Status Recruiting
Phase Phase 1
Start date September 2010
Completion date December 2017
View Details
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