Safety & Immunogenicity of HIVAX in HIV-1 Infected Subjects

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

Status Recruiting

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

HIV Infections

Clinical Trial Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms