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M94A2862.TXT
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1994-10-25
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).