16 research outputs found
Safety and efficacy trial of adipose-tissue derived oral preparation V-6 Immunitor (V-6): results of open-label, two-month, follow-up study
<p>Abstract</p> <p>Background</p> <p>Chronic inflammations, atherosclerosis and obesity, are major risk factors for cardiovascular diseases. Immune modulation of the inflammatory response has shown promise in animal models of atherogenesis and metabolic disease. Tableted dietary supplement, V-6, containing pooled antigens derived from pig adipose tissue has been administered daily to 12 volunteers for 2 months.</p> <p>Results</p> <p>No significant changes were observed in liver ALT and AST enzymes, i.e., 28 vs 23.8 IU and 22.6 vs 24.8 IU, with p = 0.07 and p = 0.49, respectively. Creatinine decreased; 0.88 vs 0.84 mg/dL (p = 0.05) while BUN moved upward; 14.5 vs 17.5 mg/dL (p = 0.01), but both values remained within normal range. Blood glucose remained within normal range; 96.1 vs 101.1 mg/dL (p = 0.04). Complete blood cell analysis has not revealed any change except slight increase in hemoglobin; 13.13 to 13.96 g/dL (p = 0.0002); hematocrit and red blood cells count 40.3 to 42.3% (p = 0.02) and 5.15 to 5.35 × 10<sup>6 </sup>cells/mm<sup>3 </sup>(p = 0.03) respectively. Blood pressure systolic and diastolic values were not affected, i.e., 116.1 vs 116.3 (p = 0.12) and 76.8 vs 76.6 (p = 0.99). Body weight and body mass index (BMI) remained same; 66.4 vs 66.3 kg (p = 0.47) and 25.7 vs 25.6 kg/m<sup>2 </sup>(p = 0.2). Body fat deposit indices, such as abdomen; mid-arm; and thigh circumferences declined by 3.5 cm (p = 0.008); 1.2 cm (p = 0.004); and 3.0 cm (p = 0.0007) respectively. The total cholesterol and LDL levels did not change; 195.5 vs 195.1 (-0.2%; p = 0.8) and 113.4 vs 120.3 (6.1%; p = 0.08) respectively. Triglycerides have been reduced but not statistically significant; 168.1 vs 118 mg/dL (-29.8%; p = 0.2). In contrast, HDL content had risen by 29.7% from 39.4 to 51.1 mg/dL in all 12 patients (p = 0.000003). TG/HDL ratio - a marker of insulin resistance - was reduced from 4.78 to 2.56 (-46.5%; p = 0.04).</p> <p>Conclusions</p> <p>These results demonstrate that V-6 is safe and has a potential as an anti-atherogenic and overweight/obesity immune intervention.</p
Serodeconversion of HIV Antibody-Positive AIDS Patients Following Treatment with V-1 Immunitor
It is extremely rare when HIV seropositive adult patients experience spontaneous loss
of antibodies, that is, seroreversion. The disappearance of HIV antibodies was occasionally
attributed to iatrogenic intervention—serodeconversion. Such interventions include:
HAART; oral interferon; Chinese herbal remedies; and therapeutic AIDS vaccines
derived from pooled blood. Oral therapeutic, alloimmune AIDS vaccine, V-1 Immunitor
(V1), was administered to 60000 HIV-positive Thai patients. The administration of V1
resulted in serodeconversion among 23 individuals. The patient group consisted of 9
females (39%) and 14 males (61%) including two 2-year-old boys. The age range was
2–58 years with mean/median 29/29.3 years. Patients were tested seropositive for HIV
at least once before being enrolled on V1. The duration of treatment until discovery of
seronegative status ranged between 2 weeks and 15 months with average/median 7.2/8
months. Time to seronegativity was correlated with baseline disease stage (R = 0.62; P = .002). The seronegative status was positively associated with V1-induced
undetectable or low viral load (R = 0.65; P = .0008). The odds ratio analysis comparing
the outcome of our study with published surveys of diagnostic accuracy of laboratory
tests suggested that the probability of HIV antibody testing error was remote
(P < .000001). The possible causes responsible for this unusual phenomenon are
discussed
Pilot trial of oral therapeutic HIV vaccine, V-1 Immunitor, on HIV and HIV/HCV patients in Russia
Normalization of elevated liver enzymes due to V-1 Immunitor therapy
V-1 Immunitor (V1) is an oral AIDS vaccine currently being used as a
therapeutic modality by HIV-positive patients. Upon interim analysis of
phase I safety trial it has been discovered that patients who had
elevated liver enzymes aspartate (AST/SGOT) and alanine (ALT/SGPT)
aminotransferases have experienced the reduction of enzyme levels back
to normal. Two other hepatitis markers alkaline phosphatase and
bilirubin have also decreased. V1's effect may be hepatitis-specific
since liver enzymes in normal patients treated with V1 have not changed
and three patients who were Hepatitis B antigen positive at baseline
became negative after therapy. The results suggest that V1
supplementation reduces hepatic damage caused by hepatitis viral
infection
Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB
Placebo-controlled, randomized, phase 2b trial was conducted in 34 adults comprising 18 first-diagnosed (52.9%), 6 relapsed (17.6%), and 10 MDR-TB (29.4%) cases to investigate the safety and efficacy of an oral immune adjunct (V5). The immunotherapy (N = 24) and placebo (N = 10) arms received once-daily tablet of V5 or placebo for one month in addition to conventional anti-TB therapy (ATT) administered under directly observed therapy (DOT)
SHORT COMMUNICATION - Normalization of elevated liver enzymes due to V-1 Immunitor therapy
V-1 Immunitor (V1) is an oral AIDS vaccine currently being used as a therapeutic modality by HIV-positive patients. Upon interim analysis of phase I safety trial it has been discovered that patients who had elevated liver enzymes aspartate (AST/SGOT) and alanine (ALT/SGPT) aminotransferases have experienced the reduction of enzyme levels back to normal. Two other hepatitis markers alkaline phosphatase and bilirubin have also decreased. V1's effect may be hepatitis-specific since liver enzymes in normal patients treated with V1 have not changed and three patients who were Hepatitis B antigen positive at baseline became negative after therapy. The results suggest that V1 supplementation reduces hepatic damage caused by hepatitis viral infection