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).