title: A randomized trial of interferon alpha therapy for HIV type 1 infection.
abstract: 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.
authors.affiliation: Vanderbilt University Medical Center, Nashville, Tennessee 37212, USA. david.w.haas@vanderbilt.edu
authors.forename: D W
authors.initials: DW
authors.lastname: Haas
authors.forename: J
authors.initials: J
authors.lastname: Lavelle
authors.forename: J P
authors.initials: JP
authors.lastname: Nadler
authors.forename: S B
authors.initials: SB
authors.lastname: Greenberg
authors.forename: P
authors.initials: P
authors.lastname: Frame
authors.forename: N
authors.initials: N
authors.lastname: Mustafa
authors.forename: M
authors.initials: M
authors.lastname: St Clair
authors.forename: R
authors.initials: R
authors.lastname: McKinnis
authors.forename: L
authors.initials: L
authors.lastname: Dix
authors.forename: M
authors.initials: M
authors.lastname: Elkins
authors.forename: J
authors.initials: J
authors.lastname: Rooney
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D004352:Drug Resistance, Microbial; D005260:Female; D016655:HIV Core Protein p24 / Q000097:blood; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood
chemical_list: D019380:Anti-HIV Agents; D016655:HIV Core Protein p24; D016898:Interferon-alpha; D012367:RNA, Viral