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M9470085.TXT
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1994-07-02
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Document 0085
DOCN M9470085
TI Zidovudine and interferon-alpha combination therapy versus zidovudine
monotherapy in subjects with symptomatic human immunodeficiency virus
type 1 infection.
DT 9409
AU Frissen PH; van der Ende ME; ten Napel CH; Weigel HM; Schreij GS;
Kauffmann RH; Koopmans PP; Hoepelman AI; de Boer JB; Weverling GJ; et
al; Department of Internal Medicine, Academic Medical Center,;
Amsterdam, Netherlands.
SO J Infect Dis. 1994 Jun;169(6):1351-5. Unique Identifier : AIDSLINE
MED/94253599
AB Forty-five subjects with symptomatic human immunodeficiency virus type 1
(HIV-1) infection, CD4+ lymphocyte counts of > or = 150 x 10(6)/L, and
Karnofsky scores > or = 60 were enrolled in a multicenter, randomized,
controlled trial that compared zidovudine monotherapy and combination
therapy for 48 weeks with zidovudine and interferon-alpha (IFN-alpha).
Zidovudine with IFN-alpha (n = 25) had a favorable effect on CD4+ cell
counts compared with zidovudine alone (n = 20). At all time points
analyzed, the mean change from baseline was higher, reaching
significance at week 24 (+10% versus -21%; P = .029). At week 48 the
difference was -12% versus -45% (P = .07). Anti-CD3 monoclonal
antibody-induced T cell reactivity improved temporarily in both groups.
Serum HIV p24 antigen levels decreased maximally during the first 12
weeks of treatment. At weeks 0 and 48, polymerase chain reaction
analysis for mutations at codons 67 and 215 of the HIV-1 reverse
transcriptase gene conferring zidovudine resistance was conducted in 10
subjects receiving zidovudine and in 8 subjects receiving combination
therapy. At week 48, 1 of 8 and 4 of 6 samples from the groups receiving
zidovudine only or combination therapy, respectively, contained wild
type virus at codon 215. Grade 3 or 4 toxicity was uncommon.
Drug-related malaise and anorexia were observed more frequently in
patients receiving both zidovudine and IFN-alpha.
DE Adult Drug Therapy, Combination Female Human HIV Infections/*DRUG
THERAPY/IMMUNOLOGY/PHYSIOPATHOLOGY HIV-1/*DRUG EFFECTS
Interferon-alpha/ADVERSE EFFECTS/*THERAPEUTIC USE Male Polymerase
Chain Reaction Support, Non-U.S. Gov't T4 Lymphocytes/IMMUNOLOGY
Zidovudine/ADVERSE EFFECTS/*THERAPEUTIC USE CLINICAL TRIAL JOURNAL
ARTICLE RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).