Document 0370
 DOCN  M9550370
 TI    Human immunodeficiency virus type 1 quantitative cell microculture as a
       measure of antiviral efficacy in a multicenter clinical trial.
 DT    9505
 AU    Fiscus SA; DeGruttola V; Gupta P; Katzenstein DA; Meyer WA 3rd; LoFaro
       ML; Katzman M; Ragni MV; Reichelderfer PS; Coombs RW; Department of
       Microbiology and Immunology, University of North; Carolina, Chapel Hill.
 SO    J Infect Dis. 1995 Feb;171(2):305-11. Unique Identifier : AIDSLINE
       MED/95146775
 AB    A quantitative cell microculture assay (QMC) was used to measure the
       human immunodeficiency virus type 1 (HIV-1) peripheral blood mononuclear
       cell (PBMC)-associated titer in 109 subjects rolled in an open-label
       phase I/II study of didanosine monotherapy or combination therapy with
       zidovudine. The titer was inversely correlated with CD4+ cell count at
       baseline (r = .37, P = .001). After 12 weeks of therapy, subjects showed
       a significant decreases in virus titer and those with the highest
       baseline virus titers had the greatest increase in CD4+ cell number (r =
       .430, P = .002). The QMC assay was more sensitive (98%) for assessing
       the antiretroviral effect of therapy than was immune complex-dissociated
       HIV p24 antigen (32%) or plasma culture (3.4%). Estimated sample sizes
       for phase I/II clinical trials were derived using the within-subject QMC
       SD of .72 log10 infectious units per 10(6) PMBC.
 DE    CD4 Lymphocyte Count  Didanosine/*THERAPEUTIC USE  Drug Therapy,
       Combination  Human  HIV Core Protein p24/BLOOD  HIV Infections/*DRUG
       THERAPY/VIROLOGY  HIV-1/*DRUG EFFECTS/GROWTH & DEVELOPMENT  Leukocytes,
       Mononuclear/VIROLOGY  Support, U.S. Gov't, P.H.S.  Treatment Outcome
       Virus Cultivation/*METHODS  Zidovudine/*THERAPEUTIC USE  CLINICAL TRIAL
       CLINICAL TRIAL, PHASE I  CLINICAL TRIAL, PHASE II  JOURNAL ARTICLE
       MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

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