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

The immunologic and virologic efficacy and safety of interferon a (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...

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Published inAIDS research and human retroviruses Vol. 16; no. 3; p. 183
Main Authors Haas, D W, Lavelle, J, Nadler, J P, Greenberg, S B, Frame, P, Mustafa, N, St Clair, M, McKinnis, R, Dix, L, Elkins, M, Rooney, J
Format Journal Article
LanguageEnglish
Published United States 10.02.2000
Subjects
Adolescent
Adult
Anti-HIV Agents - adverse effects
Anti-HIV Agents - therapeutic use
CD4 Lymphocyte Count
Drug Resistance, Microbial
Female
HIV Core Protein p24 - blood
HIV Infections - blood
HIV Infections - drug therapy
HIV Infections - immunology
HIV Infections - virology
HIV-1
Humans
Interferon-alpha - adverse effects
Interferon-alpha - therapeutic use
Male
Middle Aged
RNA, Viral - blood
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Summary:The immunologic and virologic efficacy and safety of interferon a (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.
ISSN:0889-2229
DOI:10.1089/088922200309278