A multicenter, randomized, controlled trial of three preparations of low-dose oral alpha-interferon in HIV-infected patients with CD4(+) counts between 50 and 350 cells/mm(3)

To evaluate the effectiveness of low-dose oral alpha-interferon (alpha-IFN) , 247 HIV-infected study subjects received placebo, Alferon LDO, Veldona, o r Ferimmune in a randomized, double-blind trial. Subjects had CD4(+) counts between 50 and 350 cells/mm(3) and HIV-related symptoms at entry. Study su bjects rated the severity of eight symptoms using a symptom burden index (S BI). Study endpoints included changes in SBI, weight, CD4(+) count, and Kar nofsky score between baseline and the 24-week visit. The SBI outcome and we ight were measured in 99 and 106 study subjects, respectively, at both the baseline and 24-week visits. Baseline SBI scores ranged from 5.4 to 7.9 in the four arms. No clinically important or statistically significant differe nces were found among the four arms with regard to SBI or weight change ove r the 24-week period. There were also no significant differences among the arms for CD4(+) cell count and Karnofsky score. Few adverse reactions were noted in any arm, and there were no significant differences between arms. A lthough the trial was designed to enroll 560 study subjects and was prematu rely terminated because of slow accrual and discontinuations of participant s, the small differences among the arms in the primary and secondary endpoi nts do not support claims of efficacy for the measures studied.