Document 2867
 DOCN  M94A2867
 TI    Didanosine (DDI) vs zidovudine (ZDV) in HIV patients.
 DT    9412
 AU    Milini P; Casari S; Donisi A; Gregis G; Tomasoni D; Bergamasco A; Carosi
       G; Inst. of Infectious and Tropical Dis., Univ. of Brescia, Italy.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):207 (abstract no. PB0256). Unique
       Identifier : AIDSLINE ICA10/94369708
 AB    OBJECTIVE: To value efficacy and tollerability of DDI therapy versus ZDV
       in patients with HIV infection. METHODS: A case-control, randomized,
       open study. Patients (pts): ARC subjects (CDC '87) with CD4+ cell count
       < 500, naive for antiretroviral therapy, without haematological,
       hepatic, renal and pancreatic abnormalities. Drug dosage and schedule:
       DDI mg 500-750/day or ZDV mg 600-800/day in according to body weight.
       End points: Efficacy: progression to AIDS, death and trend of surrogate
       markers (CD4+, p24Ag, beta 2-microglobulin). Tollerability: bone marrow
       toxicity, liver, renal and pancreatic impairment. Statistical analysis:
       Anova/Kruskall Wallis test, Chi-square, Fisher test (cut off = 0.05).
       RESULTS: During the period 1990-1993, 21 pts were enrolled in the study
       (M. 71.4%, F. 28.6%; IVDU 76.2%, heterosexual 23.8%) (DDI 42.9% and ZDV
       57.1%). Both DDI and ZDV groups were homogeneous for sex, age, risk
       factor, mean CD4+ (DDI = 252/cmm, ZDV = 200/cmm), p24 Ag and beta
       2-microglobulin. In the two groups (DDI or ZDV) the median follow-up was
       84 wks, the median treatment period was 81 wks. AIDS progression was
       observed in 4 pts (19%) (3 pts in ZDV, 1 pt in DDI). Four pts died (2 in
       ZDV and 2 in DDI). Significant differences were observed in the mean of
       CD4+ at 72 wks (DDI = 532/cmm ZDV = 254/cmm; p = 0.02) and at 84 wks
       (DDI = 450/cmm ZDV = 218/cmm; p = 0.03). No differences were observed in
       p24 Ag titer and beta 2 microglobulin. We found a significant decrease
       in Hgb and neutrophils for the ZDV group and an increase in uric acid
       for the DDI group as signs of toxicity. CONCLUSIONS: Our data suggest a
       higher efficacy of DDI therapy on CD4+ cell count trend and confirm its
       better tollerability, in ARC patients.
 DE    Acquired Immunodeficiency Syndrome/PREVENTION & CONTROL  AIDS-Related
       Complex/*DRUG THERAPY  Case-Control Studies  Comparative Study
       Didanosine/ADVERSE EFFECTS/*THERAPEUTIC USE  Female  Human  Leukocyte
       Count  Male  Treatment Outcome  T4 Lymphocytes  Zidovudine/ADVERSE
       EFFECTS/*THERAPEUTIC USE  CLINICAL TRIAL  MEETING ABSTRACT  RANDOMIZED
       CONTROLLED TRIAL

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