Objective: We hypothesized that treatment of HIV-1-seropositive study subjects receiving potent antiviral therapy with an HIV-specific immune-based therapy would increase HIV-1-specific T-helper immune function.

Design: 10 HIV-1-seropositive study subjects receiving antiretroviral therapy were treated with an inactivated, gp120-depleted immunogen in IFA (HIV-1 immunogen, Remune) at baseline, week 12, and week 24.

Methods: The frequency of HIV-1 antigen-stimulated interferon-[gamma](IFN-[gamma]) producing cells was determined by the ELISPOT assay.

Results: Study subjects significantly increased their frequency of HIV-1-stimulated (p<. 001) or p24 antigen-stimulated (p<. 01) IFN-[gamma]-producing cells after one, two, and three treatments of HIV-1 immunogen. Depletion of CD4 cells resulted in the strongest abrogation of the IFN-[gamma] response. The frequency of HIV-1 (r= 0.64; p=. 0002) and p24 (r= 0.72; p<. 001) antigen-stimulated IFN-[gamma]-producing cells in the CD8-depleted population before and after treatment was associated with the lymphocyte-proliferative response.

Conclusions: Treatment with HIV-1 immunogen significantly enhanced the frequency of HIV-1-specific IFN-[gamma]-producing cells. Studies are ongoing to determine the relationship between this reversal of HIV-specific anergy and virologic outcomes.