Prolonged survival of end-stage AIDS patients immunized with therapeutic HIV vaccine V-1 Immunitor

Death, rather than surrogate markers, is a single and most straightforward clinical endpoint, defining unequivocally the merit of a therapeutic intervention. As there is still neither a cure for AIDS nor a vaccine to prevent HIV infection, an AIDS diagnosis remains associated with a death sentence. V-1 Immunitor (V1) is an experimental, oral, therapeutic AIDS vaccine licensed as a dietary supplement. As part of a charity program V1 has been offered at Wat Phra Baht Nam Phu-a Buddhist hospice for end-stage AIDS patients. Out of 117 approached individuals, 53 decided to take V1 and 64 declined the treatment. Patients in both groups did not differ in age, gender, or severity of disease. All patients were in WHO terminal stage 4 at study entry and had received similar palliative care. None of the patients had received conventional antiviral drugs. At 9 weeks the last two patients in the non-V1 group died. In contrast, 56.6% (30/53) in the V1 group remained alive. Kaplan-Meier survival analysis showed that median short-term survival time for non-treated and treated patients was 4 and 10 weeks, respectively. The difference was statistically significant by Wilcoxon signed rank test (P = 0.000089). Patients who remained alive were followed until the last patient died at 142 weeks. Based on the main outcome, i.e. time to death, patients on V1 had a 15.8 times longer life expectancy than the control group (P < 0.000001). Observed results are encouraging and V1 needs to be tested in controlled clinical trials as a life-saving immunotherapy.