Document 0689
 DOCN  M94A0689
 TI    The Delta Study: one year later.
 DT    9412
 AU    Rawlinson M; National Centre in HIV Epidemiology & Clinical Research,;
       Darlinghurst NSW.
 SO    Annu Conf Australas Soc HIV Med. 1993 Oct 28-30;5:37 (abstract no. SC6).
       Unique Identifier : AIDSLINE ASHM5/94348966
 AB    STUDY OBJECTIVES AND METHODS: International randomised placebo
       controlled study comparing zidovudine (AZT) to combination AZT +
       dideoxycytidine(ddC) or AZT + didanosine(ddI), in terms of efficacy and
       tolerability. Stratified prior AZT exposure (naive = Dl, > 3 months =
       D2). RESULTS: 290 patients entered in Aust/NZ by July 30 1993, male =
       96%, mean age 39, mean AZT = 17.4 months, mean CD4 count at baseline =
       215 cells/mm3 = 15%. 58% asymp, 31% ARC, 11% AIDS. 24% of subjects have
       ceased study meds. 7% adverse incl. serious events. 16 subjects (6%)
       progressed to study end points. Week 24, mean increase Dl CD4 count =
       102 cells/mm3 and D2 mean decrease of 5 cells/mm3. Overall, baseline
       factors assoc. with a greater CD4 rise incl. higher CD4 count, less
       prior AZT, asymptomatic disease (p < 0.001). Only sig. predictor of
       toxicity defined by discontinuation of study medication is baseline CD4
       count (50 < CD4 < 200 cells/mm3) having significantly lower risk (p =
       0.049). CONCLUSIONS: Delta & ACTG 175 study will likely represent the
       definitive studies comparing nucleoside combinations to AZT monotherapy.
       Accrual of 290 subjects in Aust/NZ in 12 months reaffirms the benefits
       of multicentre studies within the local context. Preliminary analysis
       suggests greater CD4 increases and better tolerance in asymptomatic
       subjects with little/no prior AZT exposure and with higher baseline CD4
       counts.
 DE    Adult  Comparative Study  Didanosine/ADVERSE EFFECTS/*THERAPEUTIC USE
       Drug Therapy, Combination  Female  Human  HIV Infections/*DRUG
       THERAPY/MICROBIOLOGY  HIV-1/*DRUG EFFECTS/GENETICS  Leukocyte Count/DRUG
       EFFECTS  Male  T4 Lymphocytes/DRUG EFFECTS  Zalcitabine/ADVERSE
       EFFECTS/*THERAPEUTIC USE  Zidovudine/ADVERSE EFFECTS/*THERAPEUTIC USE
       CLINICAL TRIAL  MEETING ABSTRACT  MULTICENTER STUDY  RANDOMIZED
       CONTROLLED TRIAL

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