REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study

REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study

The primary objective is to compare & evaluate between the treatment groups the changes in decline/reduction of HIV viral load & increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune placebo groups. Additional objectives include changes in CD4+ & CD8+ T cell counts along with increased HIV immunity.

This is a 26 subject Multi Center double-blind randomized, Safety & Efficacy, pediatric HIV/AIDS Phase II study, to primarily to evaluate the safety and efficacy of HIV-1 immunogen and secondarily to examine changes in CD4+ & CD8+ T cell counts, determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen on viral replication in children with HIV-1 infection & immunogenicity of Remune. Multi-center, randomized , double-blind, placebo-controlled, two arm parallel design study of Remune.

Inclusion Criteria:

• Children clinically diagnosed with HIV that are 3 months of age to the age 16 years old
• Subjects on any approved FDA antiviral medication except triple cocktail HAART drugs

Exclusion Criteria:

• Truvada
• Triple cocktail HAART drugs
• Healthy subjects