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M9490532.TXT
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1994-09-24
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).