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M94A2851.TXT
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1994-10-25
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Document 2851
DOCN M94A2851
TI Comparative evaluation of ZDV and ddI in AIDS patients with previous ZDV
treatment. A randomized multicenter study ISS-901. Italian AZT/DDI
Evaluation Group.
DT 9412
AU Tomino C; Floridia M; Chiesi A; Dally LG; Seeber A; Fragola V;
Sebastiani G; Vella S; Lab. of Virology, Istituto Superiore di Sanita,
Rome.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):210 (abstract no. PB0271). Unique
Identifier : AIDSLINE ICA10/94369724
AB OBJECTIVES: To evaluate in patients with AIDS the possible benefit of
switching to didanosine after 6-18 months of AZT treatment in terms of
survival and onset of new AIDS-defining diseases. METHODS: Multicenter,
open, randomized study. AIDS patients with at least 6 months of AZT
therapy, with no major intolerance, were randomly assigned to continue
AZT or be switched to DDI. Major end-points for efficacy were survival
and development of new AIDS-defining diseases. Major end-points for
toxicity were adverse events leading to discontinuation of treatment.
RESULTS: The study started in September 1990. Follow-up closure date was
July 31, 1993. Mean follow up was 16 months. Baseline characteristics of
patients enrolled are outlined below (Table 1): The results of a
survival analysis performed on an intention to treat approach are
reported below (Fig. 1). The CD4 response for the two groups is shown in
Fig.2. CONCLUSION: Results do not show significant benefit in terms of
survival in DDI-switched patients. Switching to DDI, however, seems to
delay the decrease in CD4+ count. TABULAR DATA, SEE ABSTRACT VOLUME.
DE Acquired Immunodeficiency Syndrome/*DRUG THERAPY/MORTALITY Adult
AIDS-Related Opportunistic Infections/PREVENTION & CONTROL Comparative
Study Didanosine/*THERAPEUTIC USE Female Human Leukocyte Count Male
Survival Analysis Treatment Outcome T4 Lymphocytes
Zidovudine/*THERAPEUTIC USE CLINICAL TRIAL MEETING ABSTRACT
MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).