       Document 0582
 DOCN  M9610582
 TI    Survival effects of ZDV, ddI, and ddC in patients with CD4 < or = 50
       cells/mm3.
 DT    9601
 AU    Kazempour K; Kammerman LA; Farr SS; Division of Biometrics, USFDA,
       Rockville, MD 20857, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10 Suppl 2:S97-106.
       Unique Identifier : AIDSLINE MED/96033819
 AB    Seven major clinical trials for the treatment of HIV-infected
       individuals are investigated. The treatments used in these trials were
       zidovudine, dideoxyinosine, dideoxycytosine, and one combination for
       patients with CD4 cell counts < 500 cells/mm3. Patients in each trial
       are partitioned into two subgroups based on their baseline CD4 cell
       counts: patients with CD4 < or = 50 cells/mm3 and patients with CD4 > 50
       cells/mm3. The difference between treatment effects, using survival as a
       measure of effect, within each subgroup is calculated separately for
       each trial; this difference is referred to as subgroup response. For
       each trial the difference between the subgroup responses is calculated
       and standardized. A meta-analysis is conducted over all seven trials for
       the differences between subgroup responses; the consistency of responses
       is evaluated across all trials among patients within baseline CD4
       subgroups. Based on the result of this meta-analysis we conclude that
       there is no evidence that the treatment effects in patients with CD4 <
       or = 50 cells/mm3 are different from those among patients with CD4 > 50
       cells/mm3. This result is observed in patients with different antiviral
       experience and different baseline characteristics. Risk ratios as well
       as chi 2 statistics are used to quantify the response rates in different
       subgroups. Kaplan-Meier curves of survival for these trials are depicted
       for all patients and each subgroup separately. In most of the trials the
       Kaplan-Meier curves for the patients with CD4 < or = 50 cells/mm3
       resemble those for all patients.(ABSTRACT TRUNCATED AT 250 WORDS)
 DE    Antiviral Agents/*THERAPEUTIC USE  Clinical Trials, Phase II  Clinical
       Trials, Phase III  CD4 Lymphocyte Count  Didanosine/*THERAPEUTIC USE
       Double-Blind Method  Human  HIV Infections/*DRUG THERAPY/*MORTALITY
       Randomized Controlled Trials  Risk Assessment  Survival Analysis
       Zalcitabine/*THERAPEUTIC USE  Zidovudine/*THERAPEUTIC USE  JOURNAL
       ARTICLE  META-ANALYSIS

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

