       Document 1016
 DOCN  M9621016
 TI    In vivo effects of interleukin 3 in HIV type 1-infected patients with
       cytopenia.
 DT    9602
 AU    Scadden DT; Levine JD; Bresnahan J; Gere J; McGrath J; Wang Z; Resta DJ;
       Young D; Hammer SM; Division of Hematology/Oncology, New England
       Deaconess Hospital,; Harvard Medical School, Boston, Massachusetts
       02215, USA.
 SO    AIDS Res Hum Retroviruses. 1995 Jun;11(6):731-40. Unique Identifier :
       AIDSLINE MED/96078234
 AB    OBJECTIVE: To determine the safety, tolerance, and hematological and
       virological effects of the recombinant hematopoietic growth factor
       interleukin 3 (IL-3) in HIV-1-infected individuals with cytopenia.
       DESIGN AND METHODS: A phase I single-center trial was conducted with
       patients in cohorts of three receiving one of four dose levels of
       self-administered, subcutaneously injected IL-3 (0.5, 1.0, 2.5, or 5.0
       micrograms/kg/day). Toxicities, hematological effects, and virological
       effects were recorded. Viral studies included serum HIV p24 antigen
       levels, quantitative plasma and peripheral blood mononuclear cell
       cultures, and quantitative, competitive polymerase chain reaction of
       patient plasma. RESULTS: Increases in white blood cell counts (WBC) and
       absolute neutrophil counts (ANC) were noted at the higher dose levels
       while absolute eosinophil counts (AEC) increased in all patients. The
       percent changes in WBC from baseline ranged from 52 to 309 and in ANC
       from 20 to 262 in the 2.5- and 5.0-micrograms/kg/day groups. The mean
       AEC change was 17-fold (range, 2- to 59-fold). Hemoglobin, hematocrit,
       platelets, and CD4 and CD8 counts were generally unaffected although
       individual patients demonstrated increases in hemoglobin and platelet
       levels. Toxicities were generally mild, but one patient developed a
       transient local erythematous rash at the sites of IL-3 injection which
       pathologically demonstrated hypersensitivity vasculitis. Of note, viral
       studies did not demonstrate any consistent changes in HIV-1 activity.
       CONCLUSION: These data demonstrate limited hematological effects of IL-3
       monotherapy in HIV-1-infected patients with cytopenia. However, should
       IL-3 be incorporated into combination cytokine therapies for HIV
       disease, these data suggest that IL-3 does not enhance in vivo HIV-1
       activity.
 DE    Adult  Blood Cell Count  Cohort Studies  Human  HIV Core Protein
       p24/ANALYSIS  HIV Infections/*COMPLICATIONS  *HIV-1
       Interleukin-3/ADVERSE EFFECTS/*THERAPEUTIC USE  Leukocytes,
       Mononuclear/VIROLOGY  Leukopenia/COMPLICATIONS/*DRUG THERAPY  Male
       Middle Age  Polymerase Chain Reaction/METHODS  Recombinant
       Proteins/ADVERSE EFFECTS/THERAPEUTIC USE  RNA, Viral/BLOOD  Virus
       Cultivation  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).

