Document 0532
 DOCN  M9490532
 TI    [Controlled, clinical trial of isoprinosine administration to
       HIV-infected patients. Results of a Danish/Swedish multicenter study.
       The Scandinavian Isoprinosine Study Group]
 DT    9411
 AU    Thorsen S; Pedersen C; Sandstrom E; Petersen CS; Norkrans G; Gerstoft J;
       Karlsson A; Christensen KC; Hakansson C; Pehrson PO; et al;
       Infektionsmedicinsk afdeling, Hvidovre Hospital, Kobenhavn.
 SO    Ugeskr Laeger. 1994 May 30;156(22):3314-8. Unique Identifier : AIDSLINE
       MED/94345841
 AB    The safety and efficacy of isoprinosine in HIV-infected individuals were
       assessed in a multicentre, randomized, double-blind, 24-week study
       phase, followed by an optional 24-week open treatment phase. The results
       of the double-blind phase have been reported separately. Of 866
       HIV-seropositive individuals randomized, 832 were eligible for efficacy
       analysis. On completion of the double-blind phase, 596 patients started
       open treatment. All patients were evaluated with regard to progression
       to AIDS. Within 48 weeks, 10/412 patients (2.4%) assigned isoprinosine
       and 27/420 (6.4%) assigned placebo progressed to AIDS (p = 0.005; odds
       ratio: 2.8, 95% CI: 1.3-6.2). Intention-to-treat analysis showed
       identical results. No severe adverse reactions or toxicities were
       observed. We conclude that HIV-infected individuals without AIDS may be
       safely and effectively treated with isoprinosine.
 DE    Acquired Immunodeficiency Syndrome/ETIOLOGY/*PREVENTION & CONTROL
       Denmark  Double-Blind Method  English Abstract  Human  HIV
       Infections/*DRUG THERAPY  Isoprinosine/*ADMINISTRATION & DOSAGE  Sweden
       CLINICAL TRIAL  JOURNAL ARTICLE  MULTICENTER STUDY  RANDOMIZED
       CONTROLLED TRIAL

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