ADVR Presents Final Results of Phase I/II Trial of AVR118 in AIDS Patients

Advanced Viral Research (ADVR) has presented final results of its Phase I/II clinical trial of AVR118 in patients with AIDS.

A total of 30 cachectic patients with AIDS wasting were enrolled in the trial, which was conducted in Israel at the Kaplan Medical Center. Three groups of 10 patients each received AVR118 subcutaneously at a dose of 0.4, 2 or 4 mL/day for 28 days (six days/week).

All patients were followed for 28 days after treatment was completed. Total weight, body mass index (BMI), fat percentage, strength, calf and arm circumference, and skin-fold thickness were measured for all patients. Spontaneous patient comments regarding quality-of-life parameters, including improvement in mood, appetite, alertness, activities of daily living, malaise, myalgia and power/energy were recorded. Adverse events were monitored.

All dose groups showed an improvement in weight, strength, BMI, and calf circumference, with more significant improvements in the two higher dose levels. The patients at the highest dose appeared to have the most benefit. Twenty-nine of the 30 patients had anorexia before beginning treatment with AVR118. Anorexia resolved in a dose-related fashion, with all patients at the highest dose becoming anorexia-free after three weeks of treatment. Benefit appeared to continue beyond the end of dosing, with all patients being free from anorexia four weeks after receiving the last dose of AVR118.

Spontaneous patient comments reflect widespread, dose-related improvements in quality of life. Many patients reported improvement in mood, decreased fatigue and increased activity level. More benefits were reported by patients on the highest dose level than at the lower two dose levels. AVR118 continues to show a favorable safety profile. Adverse events reported did not appear to be drug related, and there did not appear to be any relationship between the dose level and the appearance of any adverse event.