Phase II placebo-controlled study of V-1 Immunitor as a therapeutic modality for treatment of HIV

Background: V-1 Immunitor (V1) is an oral AIDS vaccine containing heat- and chemically-in activated viral antigens derived from pooled blood of HIV-positive donors. V1 has a pending status as an investigational drug but is currently marketed as a dietary supplement. Earlier published, uncontrolled studies of V1 demonstrated body weight gain, increase in T-lymphocyte numbers, decrease in viral load, and improved survival of end-stage AIDS patients. Objectives and study design: In order to substantiate prior observations we have undertaken a placebo-controlled phase II clinical trial involving 47 antiviral therapy naive, asymptomatic individuals who had over 350 mm(3) CD4 T-cells (mean/median 538/480) at study entry. Both placebo and treatment arms were identical demographically and by every clinical parameter measured at baseline. Results and conclusions: At the end of 6-month follow-up 29 volunteers who received V1 b.i.d. had gained on average 43 CD4 T-cells (540 versus 583). This gain was statistically significant (p = 0.01) while changes in T-cell numbers in placebo group failed to reach the significance threshold (p = 0.33). The clinical potential of V1 is further supported by an elevation in CD4/CD8 ratio among V1 recipients and decline in CD4/CD8 ratio in patients on placebo (0.575 versus 0.524; p = 0.02). The average weight gain among patients on V1 was 1.8 kg while placebo group lost 0.5 kg. These results suggest that V1 may delay or reverse the disease progression without any concurrent toxicity and support our prior open-label studies indicating that V1 confers clinical benefit. A phase III clinical study is required to confirm these findings and to allow us to seek license for V1 as a therapeutic AIDS vaccine. (C) 2004 Elsevier B.V. All rights reserved.