Low dose oral interferon alpha 2a in HIV-1 seropositive patients: A double-blind, placebo-controlled trial

Low dose oral interferon alpha has been shown to be of benefit in viral dis ease in animals. In a double-blind, placebo-controlled trial, 177 patients seropositive for HIV-1 were randomly assigned to receive placebo or recombi nant human interferon alpha 2a (rIFN alpha). Endpoints were survival? alter ation of disease classification? performance, and changes in CD4(+) T cell numbers. There was a trend for improved survival in the group receiving rIF N alpha at the dose of 1.0 IU/lb. The changes in disease classification or in weight were not significantly different. Performance was improved to a g reater extent (p=0.1) in the patients who received the two higher rIFN alph a dosages (1.0 IU/lb and 10.0 IU/lb) at 6 months. In addition, the CD4(+) T cell count was improved only in the 1.0 IU/lb dose treatment group at 6 mo nths. Treatment with low dose oral interferon at 1.0 IU/lb was associated w ith improved CD4(+) T cell count, performance and a trend toward enhanced s urvival in HIV seropositive patients. These differences were, however, not statistically significant. A larger study, with better return rate, will be needed to determine whether low dose, oral interferon alpha is actually be neficial for these patients.