Document 2852
 DOCN  M94A2852
 TI    Zidovudine & alpha-interferon vs zidovudine alone in HIV infected
       persons with CD4+ cell counts of 150-500/mm3--results of the 'ZIDON'
       trial.
 DT    9412
 AU    Fernandez-Cruz E; Lang JM; Frissen PH; Chateauvert M; Furner V; Boucher
       CA; Dowd P; Stevens J
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):21 (abstract no. 059B). Unique
       Identifier : AIDSLINE ICA10/94369723
 AB    OBJECTIVE: To evaluate the efficacy and safety of zidovudine (ZDV) and
       lymphoblastoid interferon-alpha (IFN-alpha) combination therapy compared
       with ZDV monotherapy in HIV infected subjects with CD4+ T cell counts
       between 150 and 500/mm3. METHODS: Patients who had never received ZDV or
       IFN-alpha were randomised to ZDV 250 mg twice daily with or without 3MU
       IFN-alpha 3 times a week subcutaneously. Subjects were stratified by the
       Centers for Disease Control (CDC) 1986 HIV disease classification system
       (Group II/III or IV) and were monitored monthly for clinical and safety
       parameters, 12 weekly for CD4+ cell counts and serum p24 antigenaemia
       and at week 48 for mutations at codon 215 on the reverse transcriptase
       gene. The study was designed as a fixed sample size study but was
       amended to a sequential design to allow interim analyses after every 20
       end-points. End-points were: progression from CDC group II/III to IV,
       from group IV non-AIDS to AIDS, or from AIDS to a second AIDS defining
       condition. Two CD4+ cell counts of < 50/mm3 or death from an HIV
       associated condition were also considered as end-points irrespective of
       CDC group on entry. RESULTS: A total of 402 patients were recruited (209
       ZDV+IFN-alpha; 193 ZDV) with a median follow-up of 47 weeks. After the
       first 20 end-points (ZDV+IFN-alpha 11; ZDV 9), inspection of the data
       revealed that the difference between the two groups on the rate of
       progression was unlikely to ever be greater than or equal to the 50%
       reduction in end-points the study was powered to detect. No major
       differences between the treatment groups were seen for CD4+ cell counts
       or percentages, p24 antigenaemia or the frequency of 215 mutations. More
       adverse experiences, both haematological and subjective, were seen in
       the ZDV+IFN-alpha combination therapy group. DISCUSSION AND CONCLUSIONS:
       IFN-alpha when combined with ZDV at the dose regimen studied does not
       appear to confer any clinically worthwhile benefit compared with ZDV
       monotherapy.
 DE    Combined Modality Therapy  Comparative Study  Human  HIV/GENETICS  HIV
       Core Protein p24/ISOLATION & PURIF  HIV Infections/*DRUG
       THERAPY/*THERAPY  Interferon-alpha/*ADMINISTRATION & DOSAGE  Leukocyte
       Count  Reverse Transcriptase/GENETICS  T4 Lymphocytes
       Zidovudine/*ADMINISTRATION & DOSAGE  CLINICAL TRIAL  MEETING ABSTRACT
       RANDOMIZED CONTROLLED TRIAL

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