       Document 0522
 DOCN  M9640522
 TI    Zidovudine plus interferon-alpha versus zidovudine alone in HIV-infected
       symptomatic or asymptomatic persons with CD4+ cell counts > 150 x
       10(6)/L: results of the Zidon trial. Zidon Study Group.
 DT    9604
 AU    Fernandez-Cruz E; Lang JM; Frissen J; Furner V; Chateauvert M; Boucher
       CA; Dowd P; Stevens J; Department of Immunology, General Hospital
       Gregorio Maranon,; Madrid, Spain.
 SO    AIDS. 1995 Sep;9(9):1025-35. Unique Identifier : AIDSLINE MED/96085717
 AB    OBJECTIVE: To evaluate the efficacy and safety of zidovudine (ZDV) and
       lymphoblastoid interferon (IFN)-alpha combination therapy compared with
       ZDV monotherapy in HIV-infected subjects with CD4+ cell counts between
       150 and 500 x 10(6)/l. DESIGN: Open, randomized controlled trial with
       subjects stratified by the Centers for Disease Control and Prevention
       (CDC) 1986 classification of HIV disease (group II/III or IV). The study
       was amended to a sequential design in February 1992 to allow interim
       analyses to be conducted. SETTING: Outpatient clinics in 45 hospitals in
       Europe, Australia and Canada. PARTICIPANTS: A total of 402 previously
       untreated subjects with symptomatic HIV infection (CDC group IV) and
       CD4+ count 150-500 x 10(6)/l or asymptomatic HIV infection (CDC group
       II/III) with CD4+ count 150-350 x 10(6)/l. INTERVENTIONS: ZDV 250 mg
       twice daily with or without 3 MU subcutaneous injections of
       lymphoblastoid IFN-alpha three times per week. MAIN OUTCOME MEASURES:
       Time to development of a study endpoint defined as: progression from CDC
       group II/III to group IV, group IV non-AIDS to AIDS, or group IV AIDS to
       a second AIDS-defining condition; also CD4+ count to < 50 x 10(6)/l on
       two occasions at least 1 month apart or HIV-related death irrespective
       of CDC group on entry. RESULTS: There was no reduction in the rate of
       disease progression for patients receiving ZDV plus IFN-alpha compared
       with patients receiving ZDV alone. No major differences between the
       groups were seen for CD4+ counts or percentages, or p24 antigenaemia. In
       a subset of 70 patients, a similar proportion from both dose groups
       showed evidence of ZDV resistance after 48 weeks of treatment. More
       adverse experiences were seen in the ZDV/IFN-alpha group. CONCLUSIONS:
       Combination therapy with low dose lymphoblastoid IFN-alpha and ZDV
       revealed no clinical benefit compared with ZDV monotherapy.
 DE    Adolescence  Adult  Aged  Combined Modality Therapy  Comparative Study
       CD4 Lymphocyte Count/*DRUG EFFECTS  Dose-Response Relationship, Drug
       Drug Administration Schedule  Female  Human  HIV Core Protein p24/BLOOD
       HIV Infections/IMMUNOLOGY/*THERAPY  Injections, Subcutaneous
       Interferon-alpha/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  Male  Middle
       Age  Support, Non-U.S. Gov't  Treatment Outcome
       Zidovudine/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  CLINICAL TRIAL
       JOURNAL ARTICLE  MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

