A randomized trial of interferon alpha therapy for HIV type 1 infection

The immunologic and virologic efficacy and safety of interferon alpha (IFN- alpha) administered in combination with zidovudine (ZDV) and zalcitabine (d dC) 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 ther apy. A total of 256 subjects enrolled in an open-label, randomized controll ed trial. Subjects were randomized equally into treatment groups. All subje cts received ZDV and ddC, while half also receive IFN-alpha (3 MU subcutane ously every 24 hr), At 48 weeks the median average area under the curve min us baseline (AAUCMB) for plasma HIV-1 RNA for the two-drug group was -0.68 versus -0.75 log(10) copies/ml for the IFN-alpha group (p = 0.016). Mean HI V-1 RNA changes from baseline to 48 weeks for these groups were -0.65 and - 1.12 log(10) copies/ml, respectively (p = 0.010). The median AAUCMB for CD4 (+) cell count for the two-drug group was 28 versus -1 cells/mm(3) 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.