Objectives: Development of affordable and safe therapy to reverse the loss of body mass is of critical importance since AIDS-related wasting is associated with increased mortality.
Method: We have demonstrated earlier that oral therapeutic HIV vaccine, V-1 Immunitor (V1), tested in a small group of AIDS patients in Thailand not only increases T-cell counts and decreases the viral load but also results in weight gain and prolonged survival. To further expand this observation, we retrospectively analyzed 650 HIV-positive patients who were followed for an average of 23 weeks.
Results: The treatment with V1 resulted in a sustained and statistically significant increase in body mass across the whole population (mean+/-s.e.; 1.5+/-0.4 kg; P=6.5E-015). Among them, 384 (59%) patients gained an average of 4.2+/-0.2 kg; 107 (17%) had unchanged weight; and 159 (24%) had lost 3.8+/-0.3 kg. Thus, the prevailing majority of patients (76%) were able to gain or maintain weight. Treatment was well tolerated; in a survey of health status in a comparable but separate group of 382 patients, about 85% reported subjective improvement after V1 treatment, 6% reported no difference, and 9% of the patients reported minor adverse reactions, which did not last more than 1 week. Subjective improvement coincides with the reduction or clearance of oral thrush or mucocutaneous candidiasis in 87.5% of the patients.
Conclusions: In an open label setting, V1 increases body weight, subjective assessment of quality of life, and is safe and effective for HIV patients with weight loss. These data provide the impetus of using V-1 Immunitor as an affordable and easy-to-administer means of treating AIDS-associated wasting and opportunistic infections.