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).