REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study

REMUNE + AMPLIVAX IR103 HIV/AIDS Phase III Safety & Efficacy Study

The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load changes in the Remune + Amplivax group vs the Amplivax placebo groups. Additional objectives include changes in WBC White Blood Cell counts & CD4+ & CD8+ T cell counts along with increased HIV immunity.

This is a 500 subject Multi Center double-blind randomized, Safety & Efficacy, HIV/AIDS Phase III study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen & Amplivax compared to placebo group Amplivax in viral load, and secondarily to examine changes in CD4+ & CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen + Amplivax on viral replication in adults with HIV-1 infection & to examine immunogenicity of Remune + Amplivax in a Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune + Amplivax.

Inclusion Criteria:

• Are HIV-positive and started anti-HIV drugs soon after tests showed the presence of HIV.
• Are at least 16 years old (consent of parent or guardian required if under 18 years).

Exclusion Criteria:

• Healthy Subjects
• Currently abuse alcohol or drugs.