Document 0488
 DOCN  M9650488
 TI    Response of CD4 lymphocytes and clinical consequences of treatment using
       ddI or ddC in patients with advanced HIV infection.
 DT    9605
 AU    Goldman AI; Carlin BP; Crane LR; Launer C; Korvick JA; Deyton L; Abrams
       DI; Division of Biostatistics, School of Public Health, University of;
       Minnesota, Minneapolis 55455-0392, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Feb 1;11(2):161-9.
       Unique Identifier : AIDSLINE MED/96147316
 AB    The value of CD4 lymphocyte counts as a surrogate marker in persons with
       advanced human immunodeficiency virus infection during antiretroviral
       treatment was assessed using longitudinal models and data from the Terry
       Beirn Community Programs for Clinical Research on AIDS
       didanosine/zalcitabine trial of 467 HIV-infected patients. Patients with
       AIDS or two CD4 counts of < or = 300 who fulfilled specific criteria for
       zidovudine intolerance or failure were randomized to receive either 500
       mg didanosine (ddl) daily or 2.25 mg zalcitabine (ddC) per day. Absolute
       CD4 counts were recorded at study entry and at as many as four visits.
       Patients were followed for clinical disease progression and survival. At
       2 months, the difference in mean CD4 count from baseline was +15.4
       cells/mm3 in the ddI group but -1.3 cells/mm3 in the ddC group. Patients
       assigned to ddI had a greater chance of a CD4 response at 2 months than
       those on ddC, yet only those in the ddC group with a response showed
       significant improvement in progression of disease or survival compared
       with ddC nonresponders, ddI responders, and ddI nonresponders (p =
       0.03). We conclude that a CD4 response does not necessarily correlate
       with improved outcome and is therefore not a useful surrogate marker in
       these patients.
 DE    Antiviral Agents/*THERAPEUTIC USE  Biological Markers  Comparative Study
       CD4 Lymphocyte Count  CD4-Positive T-Lymphocytes/*IMMUNOLOGY
       Didanosine/*THERAPEUTIC USE  Disease Progression  Follow-Up Studies
       Human  HIV Infections/*DRUG THERAPY/IMMUNOLOGY/MORTALITY/PHYSIOPATHOLOGY
       *HIV-1  Regression Analysis  Support, Non-U.S. Gov't  Support, U.S.
       Gov't, P.H.S.  Survival Rate  Treatment Outcome
       Zalcitabine/*THERAPEUTIC USE  CLINICAL TRIAL  JOURNAL ARTICLE
       MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

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