Augmentation of HIV-1-specific T helper cell responses in chronic HIV-1 infection by therapeutic immunization.

Objective: To determine whether therapeutic immunization with a whole inactivated HIV-1 immunogen augments HIV-1-specific T helper cell responses in chronically infected individuals receiving suppressive antiretroviral therapy (ART).

Design: An investigator-initiated, single center, double-blind, placebo-controlled, randomized trial.

Methods: Subjects selected for study were HIV-1-infected adults on ART with an HIV-1-RNA plasma viral load of less than 500 copies/ml for at least 6 months, and a CD4 cell count greater than 250 cells/mm3 before starting ART.