AEGiS-15IAC: Phase 2 placebo-controlled trial of V-1 immunitor as a therapeutic modality.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Phase 2 placebo-controlled trial of V-1 immunitor as a therapeutic modality.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. A10105)

Bourinbaiar AS, Jirathitikal V, Metadilogkul O
Immunitor Corp., Co., Ltd., Chachoengsao , Thailand

BACKGROUND: V-1 Immunitor (V1) is an oral AIDS vaccine containing heat- and chemically-inactivated 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.

METHODS: In order to substantiate prior observations we have undertaken a placebo-controlled phase II clinical trial involving 47 asymptomatic individuals who had over 350/mm³ 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: 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 vs 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 vs 0.524; p=0.02). The average weight gain among patients on V1 was 1.8 kg while placebo group lost 0.5 kg.

CONCLUSIONS: 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 seek license for V1 as a therapeutic AIDS vaccine.

Keywords: AEGIS, AIDS Vaccines, Viral Load, Acquired Immunodeficiency Syndrome, Placebos, HIV Seropositivity, Disease Progression, Humans, therapy

040711
A10105