Safety and Efficacy of ADAPTAVIR's Ability to Eliminate Treatment-Resistant Infectious Virus in Peripheral Blood Mononuclear Cells (PBMCs)

A primary objective of this study is to assess the safety and toxicity of mDAPTA (Adaptavir) in HIV infected individuals with suppressed viral loads with HAART treatment and assess the proportion of study participants achieving PMBC viral culture negative status at 24weeks. PMBC viral culture status is a direct measurement of treatment resistant, residual, active HIV replication in the peripheral blood mononuclear cells. We hypothesize this proportion will be significantly greater in the treatment arm relative to the placebo arm (the odds of achieving this endpoint are significantly greater in mDAPTA- than in placebo-treated participants). Secondary Endpoints (all analyzed as odds ratios) are to determine * The proportion of study participants achieving (0.5 log10) decrease in quantitative viral mRNA in PBMCs will be significantly greater in the treatment arm relative to the placebo arm. * The proportion of study participants achieving (0.5 log10) decrease in quantitative viral DNA in PBMCs will be significantly greater in the treatment arm relative to the placebo arm. * The proportion of study participants whose plasma viral loads were greater than 200 copies/ml on two successive measurements 6 weeks apart will be significantly greater in the placebo arm relative to the treatment arm. Immunological outcome hypotheses, based on 24-week data * The proportion of study participants achieving at least greater than 50% decrease in the inflammatory cytokines TNFa, IL-10, IL-8 or IL-6 will be significantly greater in the treatment arm relative to the placebo arm. * The proportion of study participants achieving at least greater than 50% increase in the cytokines IL-2, IL-10, IL-12, IL-13 and IFNa will be significantly greater in the treatment arm relative to the placebo arm. * The proportion of study participants achieving at least an increase in CD4 T cells will be significantly greater in the treatment arm relative to the placebo arm. * The proportion of study participants whose viral load becomes greater than 200 copies/ml will be significantly greater in the placebo arm relative to the treatment arm.