       Document 0584
 DOCN  M9610584
 TI    Insights from monitoring the CPCRA didanosine/zalcitabine trial. Terry
       Beirn Community Programs for Clinical Research on AIDS.
 DT    9601
 AU    Fleming TR; Neaton JD; Goldman A; DeMets DL; Launer C; Korvick J; Abrams
       D; University of Washington, Department of Biostatistics, Seattle;
       98195, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10 Suppl 2:S9-18.
       Unique Identifier : AIDSLINE MED/96033807
 AB    The design, conduct, and analysis of clinical trials that evaluate the
       safety and efficacy of treatment interventions in patients with HIV
       infection provide many scientific challenges. A recently completed
       randomized trial of didanosine (ddI) and zalcitabine (ddC), sponsored by
       the Terry Beirn Community Programs for Clinical Research on AIDS
       (CPCRA), is an especially valuable resource for illustrating these
       challenging issues and for providing insights into how they might be
       properly addressed. Establishing equivalence of treatment effects on
       clinical efficacy end points is illustrated through the use of the
       confidence interval approach. The striking changes in treatment efficacy
       results that occurred during the course of the CPCRA trial provide
       important insights into how a data and safety monitoring board can
       reduce the risk of inappropriate early study termination. The trial also
       provides valuable insights into how treatment effects should be
       assessed, revealing inconsistencies between effects on the CD4 surrogate
       end point and effects on primary clinical efficacy end points and
       showing the incompleteness of the standardly employed definition of AIDS
       progression. Finally, the results of this ddI/ddC trial are used to
       examine the role of covariate adjustment.
 DE    Antiviral Agents/*THERAPEUTIC USE  Biological Markers  Confidence
       Intervals  CD4 Lymphocyte Count  Didanosine/*THERAPEUTIC USE  Disease
       Progression  Drug Monitoring  Human  HIV Infections/*DRUG THERAPY
       National Institutes of Health (U.S.)  Prognosis  Randomized Controlled
       Trials/*STANDARDS  Research Design/*STANDARDS  Severity of Illness Index
       United States  Zalcitabine/*THERAPEUTIC USE  JOURNAL ARTICLE

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

