Abstract
A randomized, controlled clinical trial was started in the pre-HAART era to compare the efficacy of zidovudine (AZT) and interferon-alpha (IFN-α) either alone or in combination to reduce HIV viremia, maintain CD4+ cell count, and decrease time to AIDS progression and death. The purpose of the current study was to compare the effects of AZT and IFN on HIV load using modern technology. One hundred and eighty patients with CD4+ counts above 500 cells/mm3 were randomized to receive AZT alone, IFN-α alone, or AZT and IFN-α in combination. CD4+ cell count and HIV load at baseline and at the last follow-up visit were compared, and time to AIDS or death was calculated by treatment group. At a mean follow-up of 45 weeks, the mean change in log HIV RNA was −0.06 for the AZT alone group, −0.47 for the AZT plus IFN-α group (P = 0.01 versus AZT group), and −0.35 for the IFN-α alone group (P = 0.02 versus AZT group). There was no significant difference among groups in change in total CD4+ count or in time to AIDS or death. Since treatment with IFN-α produces significant decreases in HIV load, additional studies of IFN-α as part of a combination regimen are warranted.
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