Document 2850
 DOCN  M94A2850
 TI    Design and implementation of a community based trial for the comparison
       of combination ZDV with ddC or ddI to ZDV monotherapy.
 DT    9412
 AU    Saravolatz L; Winslow D; Stein D; Dehlinger M; Collins G; Deyton L;
       Henry Ford Hospital, Detroit, MI 48202.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):210 (abstract no. PB0269). Unique
       Identifier : AIDSLINE ICA10/94369725
 AB    OBJECTIVE: This study compares ZDV alone with ZDV given in combination
       with either ddI or ddC with respect to efficacy and safety in HIV
       infected patients with CD4 counts of < or = 200 or AIDS in a
       community-based setting. METHODS: This randomized, modified double-blind
       trial has a target sample size of 1200, based on a 33% reduction in the
       primary outcome, progression to AIDS or death over 2 years, with 80%
       power for a global significance level of 5%. Data on progression of
       disease, survival, toxicity and CD4 counts are being collected for study
       endpoints. RESULTS: Fifteen centers enrolled 1,016 patients over 22
       months. Overall 43% of the patients are minorities, 22% intravenous drug
       users and 7.5% women. At baseline, the mean CD4 was 120, a mean duration
       of ZDV use of 12.1 months and 1/2 having had < 6 months of prior ZDV
       use. The mean Karnofsky was 91, 32% had previous AIDS defining
       opportunistic infections, and 61% were on trimethoprim/sulfamethoxazole.
       Results from other antiretroviral trials released during the recruitment
       period have not adversely affected patient enrollment or participation.
       CONCLUSION: The conduct of antiretroviral trials with clinical endpoints
       can be initiated in community-based settings with patient
       characteristics more consistent with the demographics of the HIV
       epidemic in the U.S. This study will help define the role of
       combination-nucleoside therapy in clinical practice in patients with
       moderate to advanced HIV infection with differing degrees of prior
       antiretroviral therapy.
 DE    Acquired Immunodeficiency Syndrome/PREVENTION & CONTROL  Community
       Medicine  Comparative Study  Didanosine/ADMINISTRATION & DOSAGE/ADVERSE
       EFFECTS/*THERAPEUTIC  USE  Double-Blind Method  Drug Therapy,
       Combination  Female  Human  HIV Infections/*DRUG THERAPY/MORTALITY  Male
       Research Design  Treatment Outcome  Zalcitabine/ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC  USE  Zidovudine/ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC  USE  CLINICAL TRIAL  MEETING
       ABSTRACT  MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

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