Document 2625
 DOCN  M94A2625
 TI    Paediatric European Network for Treatment of AIDS (PENTA). PENTA
       Steering Committee.
 DT    9412
 AU    Grosch-Woerner I; Castelli G; Rosado L; Debre M; Gibb DM
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):261 (abstract no. PB0472). Unique
       Identifier : AIDSLINE ICA10/94369950
 AB    The PENTA I Trial is a double blind, placebo controlled trial to
       determine the efficacy and toxicity of early compared with deferred use
       of zidovudine (ZDV) in children with early vertically acquired HIV
       disease. The trial is jointly co-ordinated by the MRC HIV Clinical
       Trials Centre and the Agence Nationale pour Recherches sur la SIDA,
       INSERM, France under the auspices of PENTA. Centres from each of 10
       countries link with one of the 2 Trials Centres; randomisation to ZDV
       syrup or placebo is performed centrally and follow-up forms are
       completed 3-monthly. Children may be transferred to open ZDV if they
       progress and all are followed to endpoints of AIDS or death. Over the
       first 18 months, 125 of the planned intake of 400 children have been
       enrolled from 32 centres in 9 countries. Age at trial entry ranged from
       4 months to 11 years and 13% were < 1 year. 27% had CD4 counts below the
       normal range at baseline and all but 12% had one or more HIV associated
       manifestations. Three children have developed AIDS and 7 have
       transferred to open ZDV for disease progression. Severe neutropenia
       resulting in dose modification developed in 3 children and in 17, minor
       gastrointestinal adverse events have occurred, 3 resulting in
       withdrawal. The Data and Safety Monitoring Committee (DSMC) recommended
       continuation of the trial in October 1993 and recruitment is being
       extended outside Europe to Canada and Brazil. The PENTA 3 Trial is a
       phase II trial comparing toxicity and tolerability of ZDV alone, with
       ZDV and Dideoxycytidine (ddC), in symptomatic antiretroviral naive
       HIV-infected children. It is due to start in 1994 with a planned intake
       of 100 children. Centres participating in these two trials will
       contribute to a European network for future studies on antiretroviral
       and other aspects for both treatment and prophylaxis in children with
       HIV infection.
 DE    Acquired Immunodeficiency Syndrome/*DRUG THERAPY/MORTALITY/
       TRANSMISSION  Child  Child, Preschool  Double-Blind Method
       Europe/EPIDEMIOLOGY  Female  Follow-Up Studies  Human  HIV
       Infections/*DRUG THERAPY/MORTALITY/TRANSMISSION  Infant  Male  Survival
       Rate  Zidovudine/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS  CLINICAL
       TRIAL  MEETING ABSTRACT  MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

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