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M94A0689.TXT
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1994-10-21
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).