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Methods 138 subjects with mean CD4 of 336 cells/ul and mean HIV-RNA of 4.9 log were enrolled in this GCP, ICH-compliant study. Subjects were randomized to receive either VGV-1 monotherapy (bovine-derived thymus nuclear protein in alum, presumable immune modulator) or control via 16 biweekly i.m. injections and followed to 240 days. Effects of antiretrovirals, provided to disease progressors, were excluded from analysis.

retrovirology

Virological responses of treatment-naïve stage CDC-2 HIV-1 positive subjects receiving VGV-1 injections in a blinded, placebo-controlled, multi-centre clinical trial