We assessed,over 51/2 year,whether anti-retroviral therapy (ART) exposure could be diminished with therapeutic vaccination (Remune) initiated after targeting the HIV reservoirs and diminishing the immune activation.Ten adults with chronic HIV infection (5 AIDS; 5 CDC C-2),HIV-1 RNA (VL) <1.7 log10 copies/ml and median (range) CD4+-T cell count of 385/1 (230-990) were enrolled into this intensive,pathogenesis-based trial.After ART intensification with ddI + GM-CSF + hydroxyurea [HU] and a first Remune vaccine dose,ART was stopped but Remune was continued every 3 months for 3 years.ART was resumed if rebound VL did not decrease to < 4.7 logl0 in 3 months or ifCD4+ counts decreased to <200 cells/1 and stopped again when CD4+ 200 and viral load 1.7.Intensive clinical,virologic,and immunologic evaluations were undertaken.Ten unmatched patients on continuos ART were followed as a concurrent comparison group.