EFFECT OF IMMUNIZATION WITH INACTIVATED GP120-DEPLETED HUMAN-IMMUNODEFICIENCY-VIRUS TYPE-1 (HIV-1) IMMUNOGEN ON HIV-1 IMMUNITY, VIRAL-DNA, AND PERCENTAGE OF CD4 CELLS

A 1-year study measured the effect of administration of an inactivated human immunodeficiency virus type 1 (HIV-1) immunogen in incomplete F reund's adjuvant (IFA) on HIV-1-specific immunity and viral burden in asymptomatic HIV-1-infected patients. A total of 103 patients were enr olled in this double-blind, randomized study comparing immunogen in ad juvant with adjuvant alone. This study was conducted at nine medical c enters throughout the United States. Significant differences in cell-m ediated immune responses to HIV-1 and p24 core antigen were observed b etween the treated and control groups (P <.01). Compared with controls , treated patients as a group had a significantly lower rate of increa se in viral DNA as determined by quantitative HIV-1 DNA-polymerase cha in reaction (P =.016). Significant differences in the rate of percent CD4 cell decline were also observed between the 2 groups (P =.024). Th ese data suggest that augmentation of HIV-1-specific immunity via immu notherapy may alter the rate of increase of HIV-1 DNA in peripheral bl ood mononuclear cells and stabilize the percent of CD4 cell decline in relatively healthy HIV-1-infected persons.