A Randomized Trial of Interferon alpha Therapy for HIV Type 1 Infection

Abstract

The immunologic and virologic efficacy and safety of interferon alpha (IFN-alpha) administered in combination with zidovudine (ZDV) and zalcitabine (ddC) was evaluated in HIV-infected subjects with CD4⁺ cell counts between 300 and 500 cells/ml and no more than 14 weeks of prior antiretroviral therapy. A total of 256 subjects enrolled in an open-label, randomized controlled trial. Subjects were randomized equally into treatment groups. All subjects received ZDV and ddC, while half also receive IFN-alpha (3 MU subcutaneously every 24 hr). At 48 weeks the median average area under the curve minus baseline(AAUCMB) for plasma HIV-1 RNA for the two-drug group was -0.68 versus -0.75 log₁₀ copies/ml for the IFN-alpha group (p = 0.046). Mean HIV-1 RNA changes from baseline to 48 weeks for these groups were -0.65 and -1.12 log₁₀ copies/ml, respectively (p = 0.010). The median AAUCMB for CD4 + cell count for the two-drug group was 28 versus -1 cells/mm³ for the IFN-alpha group (p = 0.011). Neutropenia, anemia, and drug intolerance were more common in the IFN-alpha group. This study demonstrates that IFN-alpha inhibits HIV-1 replication but attenuates the CD4⁺ cell response to dual therapy with ZDV and ddC.