Document 2866
 DOCN  M94A2866
 TI    Effects of combined treatment with zidovudine and dideoxyinosine in 104
       HIV+ patients with prior zidovudine therapy.
 DT    9412
 AU    de Saint Martin L; Pialoux G; Tuppin P; Gonzalez-Canali G; Feuillie V;
       Dupont B; Institut Pasteur Hospital, Paris, France.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):207 (abstract no. PB0258). Unique
       Identifier : AIDSLINE ICA10/94369709
 AB    OBJECTIVES: 104 HIV infected patients with infection progressing in
       spite of ongoing AZT were enrolled into a longitudinal retrospective
       study of safety and impact on disease course of combined therapy with
       zidovudine (AZT) and dideoxyinosine (ddI). METHODS: All patients of our
       AIDS clinical unit who had been treated with zidovudine alone and who
       received subsequently a combination therapy between November 17, 1990
       and December 1, 1992 were included in this study. The analysis of
       clinical manifestations was based on any significant clinical event.
       Biological evaluation included CD4+/CD8+ count and HIV p24 antigen
       level. The number of clinical events and the number of serious
       biological events, before and after onset of combined therapy was
       compared using Chi square or Fischer exact tests. Comparisons between
       pretreatment characteristics of responders and no responders were made
       using a Fischer exact test or a Kruskal Wallis test. RESULTS: the mean
       of follow up was 190 days (range 32-849). All patients were treated with
       daily doses of AZT between 200 and 600 mg (mean = 396) and daily doses
       of ddI between 100 and 600 mg (mean = 359). Study medication was
       discontinued in 34 patients, related in 17 cas to adverse reactions. The
       increase of mean slope of CD4+ lymphocytes count was significant but not
       the decrease of the mean slope of HIV p24 antigen level. Statistical
       limits of this longitudinal retrospective study do not permit to
       conclude but the efficacy at this stage of the decrease is probably
       slight. DISCUSSION AND CONCLUSION: Combined therapy with AZT and ddI
       following AZT therapy alone among patients with HIV disease progression
       showed disappointing results. The increase of the toxicity is smaller.
       The improvement of laboratory parameters of HIV infection is small
       (CD4+) or nonexistent (Ag p24). Further investigations must be performed
       to establish a long-term efficacy of antiretroviral combination.
 DE    Didanosine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC  USE
       Drug Therapy, Combination  Human  HIV Core Protein p24/BLOOD  HIV
       Infections/*DRUG THERAPY  Leukocyte Count  Longitudinal Studies
       Retrospective Studies  Safety  Treatment Outcome  T4 Lymphocytes
       Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC  USE
       CLINICAL TRIAL  MEETING ABSTRACT

       SOURCE: National Library of Medicine.  NOTICE: This material may be
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