NCT00195312

Study Evaluating Vaccine in Adults With HIV

A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Gag DNA Vaccine Administered Alone or With Escalating Doses of IL-12 DNA or IL-15 DNA Molecular Adjuvants to HIV-1 Positive Adults Receiving Stable HAART.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to learn whether the study vaccine and the adjuvants(drugs that are used to help immune response) have an acceptable safety profile in treating individuals with HIV. A second purpose for this study is to understand how your immune system responds to the study vaccine with the adjuvants. Understanding these differences could be useful in several ways. First, it might help identify people whose disease is likely to respond to the study vaccine with the study adjuvants. Second, the information might be useful in developing other treatments for people whose disease does not respond to the study vaccine with the adjuvants.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	HIV-1 gag DNA (formulated with bupivacaine)
BIOLOGICAL	IL-15 DNA (formulated with bupivacaine)
BIOLOGICAL	IL-12 DNA (formulated with bupivacaine)
BIOLOGICAL	Sodium chloride injection USP (0.9%)

Timeline

• Start date: 2005-08-01
• Completion: 2007-08-01
• First posted: 2005-09-19
• Last updated: 2007-12-05

Locations

13 sites across 3 countries: United States, Germany, Sweden