Document 0980
 DOCN  M9470980
 TI    A phase I study of subcutaneous recombinant interleukin-2 in patients
       with advanced HIV disease while on zidovudine.
 DT    9409
 AU    McMahon DK; Armstrong JA; Huang XL; Rinaldo CR Jr; Gupta P; Whiteside
       TL; Pazin GJ; Tripoli C; Ho M; Department of Infectious Diseases and
       Microbiology, Graduate; School of Public Health, University of
       Pittsburgh, Pennsylvania; 15261.
 SO    AIDS. 1994 Jan;8(1):59-66. Unique Identifier : AIDSLINE MED/94280705
 AB    OBJECTIVE: A Phase I study of subcutaneous recombinant interleukin-2
       (rIL-2). DESIGN: Sixteen patients with advanced HIV infection receiving
       600-1200 mg zidovudine per day were divided into three groups, which
       received sequentially 0.2 x 10(6), 0.7 x 10(6) or 2 x 10(6) units/m2 per
       day of rIL-2 subcutaneously 5 consecutive days. SETTING: Five-day
       admission to an academic tertiary care hospital. PATIENTS, PARTICIPANTS:
       Sixteen unblinded, non-randomized volunteers. INTERVENTIONS:
       Subcutaneous rIL-2. MAIN OUTCOME MEASURES: Tolerance, toxicity,
       hematologic, immunologic and antiviral responses. RESULTS: rIL-2 was
       well-tolerated at the highest dosage, except in two patients who
       developed significant lymphopenia by the second day of rIL-2
       administration, with rebound within 48 h after rIL-2 therapy. The number
       of eosinophils, CD4+ and CD8+ cells, and percentage of CD16+ (natural
       killer) cells, remained elevated above baseline for up to 10 weeks.
       Circulating rIL-2 receptor levels increased transiently during and
       immediately following rIL-2 administration. A twofold increase in
       natural killer cell activity against uninfected and HIV-infected targets
       was observed, but did not persist beyond 10 weeks following rIL-2
       administration. There was a transient decrease in blastogenesis to
       phytohemagglutinin of patients receiving the highest dose of r-IL-2, but
       no significant change in viral burden. CONCLUSIONS: Subcutaneous rIL-2
       in advanced HIV-infected patients on zidovudine was tolerated with
       side-effects similar to intravenous IL-2.
 DE    Adult  Drug Therapy, Combination  Human  HIV Infections/*DRUG
       THERAPY/MICROBIOLOGY  Injections, Subcutaneous
       Interleukin-2/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/  *THERAPEUTIC USE
       Killer Cells/DRUG EFFECTS/IMMUNOLOGY  Leukocytes/DRUG EFFECTS
       Lymphocyte Transformation/DRUG EFFECTS/IMMUNOLOGY  Male  Middle Age
       Receptors, Interleukin-2/ANALYSIS  Recombinant Proteins/ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS/  THERAPEUTIC USE  Support, U.S. Gov't, P.H.S.
       Zidovudine/*THERAPEUTIC USE  CLINICAL TRIAL  CLINICAL TRIAL, PHASE I
       JOURNAL ARTICLE

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