       Document 0600
 DOCN  M95A0600
 TI    Clinical characteristics of children enrolled into a randomized,
       double-blind trial of antiretroviral therapy (ACTG 152). American
       Pediatric Society 104th annual meeting and Society for Pediatric
       Research 63rd annual meeting; 1994 May 2-5; Seattle.
 DT    9510
 AU    Englund JA; Baker CJ; McKinney RE Jr; Raskino CL; Schoenfeld DA; Petrie
       BL; Lifschitz MC; O'Donnel K; Wara DW; Fowler MG; Baylor College of
       Medicine, Houston, TX, USA.
 SO    Pediatr AIDS HIV Infect. 1994 Oct;5(5):322 (unnumbered abstract). Unique
       Identifier : AIDSLINE AIDS/95330444
 AB    The first comparative antiretroviral trial in symptomatic, HIV-infected
       children evaluates the efficacy of zidovudine (ZDV) vs didanosine (DDI)
       vs ZDV plus DDI. From 8/91 to 8/93, 839 infants and children were
       enrolled from 77 sites in 20 states and Puerto Rico. All received either
       no or < 6 wks of ZDV before randomization. The age distribution was 3-12
       mo, 29% (245), > 12-30 mo, 25% (207), > 30 mo-6 yr, 24% (198) and > 6-18
       yr, 22% (189); 51% were male and 86% were from ethnic minorities.
       Clinical parameters measured at baseline included weight for age/gender
       standardized Z-scores (WAZ), head circumference (OFC), cortical atrophy
       (by CT or MRI), neurocognitive function (MDI or IQ score) and neurologic
       exam. The results are summarized below as % of subjects in each age
       group: TABULAR DATA, SEE PUBLISHED ABSTRACT. Younger children had higher
       rates of abnormalities, especially those relating to growth and
       neurological/neurocognitive function. When WAZ scores were compared to
       MDI/IQ scores, these were significantly (P < 0.01) lower for patients
       with MDI scores < 70 in all but the oldest group. These entry
       characteristics provide a description of the status of symptomatic,
       HIV-infected US children at initiation of first antiretroviral therapy.
 DE    Child  Child, Preschool  Comparative Study  Didanosine/*THERAPEUTIC USE
       Double-Blind Method  Female  Human  HIV Infections/*DRUG THERAPY  Infant
       Male  Zidovudine/*THERAPEUTIC USE  CLINICAL TRIAL  MEETING ABSTRACT
       RANDOMIZED CONTROLLED TRIAL  JOURNAL ARTICLE

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

