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- 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).
-
-