Increased body weight and improved quality of life in AIDS patients following V-1 Immunitor administration.
OBJECTIVE
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.


METHODS
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.
Jirathitikal
V
V
Immunitor Corporation Co., Ltd, Bangpakong Industrial Park, Chachoengsao, Thailand.
Metadilogkul
O
O
Bourinbaiar
A S
AS
D016915:AIDS Vaccines / Q000627:therapeutic use*; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D005260:Female; D019247:HIV Wasting Syndrome / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012189:Retrospective Studies; D016896:Treatment Outcome; D019562:Viral Load; D015430:Weight Gain
D016915:AIDS Vaccines; C452261:V-1 Immunitor