The effects of an HIV‐1 immunogen (Remune) on viral load, CD4 cell counts and HIV‐specific immunity in a double‐blind, randomized, adjuvant‐controlled subset study in HIV infected subjects regardless of concomitant antiviral drugs

Objective  We examined the activity of an HIV‐1 immunogen (Remune) on viral load, CD4 cells and HIV‐1 specific immunity.Methods  Plasma and peripheral blood mononuclear cells were obtained in a predefined random subset of subjects (n = 252) from a multicentre, double‐blind, adjuvant‐controlled phase III clinical endpoint study.Results  The subjects treated with the HIV‐1 immunogen had a significantly greater decline in viral load at multiple time points (P < 0.05), a trend towards increased CD4+ T cell counts and significantly enhanced HIV‐1 specific immune responses as measured by HIV‐1 lymphocyte proliferation (P < 0.001) compared to the adjuvant control group. Furthermore, in the HIV‐1 immunogen treated group, enhanced HIV‐1 specific lymphocyte proliferative immune responses were associated with decreased HIV‐1 plasma RNA.Conclusion  These results suggest that, in a predefined, random subset of subjects, a beneficial effect of the HIV‐1 immunogen was observed on viral load, CD4+ T cells, and HIV‐specific immunity. These differences were observed in a background of multiple drug therapies. Ongoing trials are evaluating the effect of the combination of this HIV‐1 specific, i