Document 2862
 DOCN  M94A2862
 TI    Efficacy and toxicity of DDI and AZT monotherapy versus combined and
       alternating AZT/DDI regimens.
 DT    9412
 AU    Schlenzig C; Poppinger J; Wolf E; Jaeger H; KIS--Curatorium for
       Immunedeficiency, Munich, Germany.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):208 (abstract no. PB0261). Unique
       Identifier : AIDSLINE ICA10/94369713
 AB    OBJECTIVE: To compare the efficacy and toxicity of single agent ddI and
       AZT therapy versus combined and alternating AZT/ddI regimens in 100 AZT
       and ddI virgin patients with CD4+ counts 50-300 cells/ml. METHODS: At
       time of interim analysis 50 HIV AB positive males and females had been
       randomly assigned to one of the following arms of the trial and therapy
       was applied for a medium of 20 weeks (range 4-28): A: 400 mg ddI/d; B:
       500 mg AZT/d, C: 400 mg ddI/d + 500 mg AZT/d, D: 500 mg AZT/d for 4
       weeks, alternating with 400 mg ddI/d for 4 weeks. Monthly clinical and
       laboratory evaluations were done. RESULTS: There were no clinical signs
       for progression of HIV-infection according to CDC classification in
       patients treated with ddI, whereas at least one event of clinical
       progression was noted in all other regimens. Patients increasing more
       than 50 cells/ml from baseline were found more often in combination or
       alternating therapy scheme. As presumed there were no unexpected serious
       side-effects. Further differences in toxicity and efficacy including
       changes of p24 antigen will be discussed. CONCLUSIONS: Concerning the
       limiting progression of HIV progression in this study single agent ddI
       therapy seems to have the best benefit for patients. Nevertheless
       combination as well as alternative therapy regimens show increases of
       CD4 cells from baseline. Further results including virology and
       resistance data will be presented.
 DE    Comparative Study  Didanosine/ADMINISTRATION & DOSAGE/ADVERSE
       EFFECTS/*THERAPEUTIC  USE  Drug Administration Schedule  Drug Therapy,
       Combination  Female  Human  HIV Infections/*DRUG THERAPY  Male
       Treatment Outcome  Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE
       EFFECTS/*THERAPEUTIC  USE  CLINICAL TRIAL  MEETING ABSTRACT  RANDOMIZED
       CONTROLLED TRIAL

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