Keywords: Africa, CD4 T-cell counts, clinical endpoint, highly active antiretroviral therapy, HAART, Nigeria, surrogate markers, therapeutic AIDS vaccine, open label trial, HIV positive, blood donors, statistical analysis, immunotherapeutic modality, THIVAC
Preliminary evidence of efficacy from an open label trial of a therapeutic AIDS vaccine derived from the blood of HIV-positive donors
Two earlier reported studies indicated the beneficial clinical effects of THIVAC, a therapeutic HIV vaccine derived from the blood of HIV-positive donors. However, in those studies no stringent statistical analysis to support the beneficial clinical outcome was attempted. This report retrospectively analyses the effect of the therapy on the CD4 counts in 272 treated individuals who had at least one pair of T-cell tests carried out before and during treatment. Except for the earliest time point (median 25 days of treatment) when p = 0.11, the mean increase in CD4 counts was statistically significant at every discrete time point with peak at 112 days when p = 0.0000000000005. Despite the open label nature of this study, the results appear highly significant, supporting unequivocally the beneficial effects of THIVAC as a safe and promising immunotherapeutic modality for treating HIV.