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 CTL Multi-Epitope Peptide Vaccine Formulated With RC529-SE and GM-CSF Given to HIV-1 Positive Adults on Stable HAART.

The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV.

A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.

Inclusion Criteria:

• 18 years of age diagnosed with HIV and on stable HAART for a minimum of six months
• CD4 T-cell count greater than and equal to 350/mm3 at screening
• No reported CD4 T-cell count less than 350/mm3 at any time before screening
• Viral load less than 50 copies/mL at screening and no viral load greater than 400 copies/mL for a minimum of six months prior to screening

Exclusion Criteria:

• Any chronic symptomatic infection other than HIV
• Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening
• Any malignancy that may require systemic therapy
• Use of any investigational treatment within six months before screening or planned during study enrollment, except for investigational retrovirals obtained through ACTG