A double-blind, adjuvant-controlled trial of human immunodeficiency virus type 1 (HIV-1) immunogen (Remune) monotherapy in asymptomatic, HIV-1-infected Thai subjects with CD4-Cell counts of > 300

We examined the effect of a human immunodeficiency virus (HIV)-specific imm une-based therapy in Thailand, where access to antiviral drug therapy is li mited. A 40-week trial was conducted with 297 asymptomatic, HIV-infected Th ai subjects with CD4-cell counts greater than 300 mu l/mm(3). Subjects were randomized to receive either HIV type 1 (HIV-1) immunogen (Remune; inactiv ated HIV-1 from which gp120 is depleted in incomplete Freund's adjuvant or adjuvant control at 0, 12, 24, and 36 weeks at five different clinical site s in Thailand. Neither group received antiviral drug therapy. The a priori primary endpoint for the trial was changes in CD4-cell counts with secondar y parameters of percent changes in CDS cell counts (percent CD4, CD8, and C D4/CD8) and body weight. Subsets of subjects were also examined for changes in plasma HN 1 RNA levels, Western blot immunoreactivity, and HIV-1 delaye d-type hypersensitivity (DTH) skin test reactivity. There was a significant difference in changes in CD4-cell counts that favored the HIV-1 immunogen- treated group compared to those for the adjuvant-treated control group (P < 0.05). On average, for HIV-1 immunogen-treated subjects CD4-cell counts in creased by 84 cells by week 40, whereas the increase for the control group was 38 cells by week 40. This increase in CD4-cell count was associated wit h increased HIV-specific immunogenicity, as shown by Western blotting and e nhanced HIV-1 DTH skin reactivity. No significant differences in adverse ev ents were observed between the groups. The results of this trial suggest th at HIV-1 immunogen is safe and significantly increases CD4-cell counts and HIV-specific immunity compared to those achieved with the adjuvant control in asymptomatic HIV-l-infected subjects not taking antiviral drugs.