       Document 0746
 DOCN  M9640746
 TI    Continuous low-dose interferon-alpha therapy for HIV-related immune
       thrombocytopenic purpura.
 DT    9604
 AU    Northfelt DW; Charlebois ED; Mirda MI; Child C; Kaplan LD; Abrams DI;
       Department of Medicine, University of California, San Francisco;
       94143-1270, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Jan 1;8(1):45-50.
       Unique Identifier : AIDSLINE MED/96142199
 AB    Our objective was to examine the efficacy and toxicity of continuous,
       low-dose interferon-alpha therapy for human immunodeficiency
       virus-related immune thrombocytopenic purpura (HIV-ITP) in a Phase II
       clinical trial overseen by a community-based consortium of physicians
       conducting clinical trials in HIV-related diseases. Sixteen patients
       with HIV-ITP defined by prospective clinical criteria were enrolled; the
       majority had failed other therapies for HIV-ITP. Baseline and serial
       measurements were made of platelet counts, complete blood counts, serum
       chemistries, platelet-associated immunoglobulin, and CD4+ T-lymphocyte
       counts; subjective symptoms and bleeding were recorded. Three million
       units of interferon-alpha 2b were self-administered by subcutaneous
       injection every Monday, Wednesday, and Friday for 16 weeks. Thirteen
       participants were evaluable for response. One obtained a complete
       response, eight had partial responses, and four had no response to
       interferon-alpha therapy. The mean absolute platelet count of the group
       rose from 15.5 x 10(9)/L at baseline to 47.3 x 10(9)/L at 2 weeks and
       remained in this range for the duration of the study. CD4+ T-lymphocyte
       counts and serum chemistries did not change significantly during
       therapy. Ability to detect platelet-associated immunoglobulin did not
       change in a predictable manner in relation to platelet count response.
       Hematologic toxicity was limited to one episode of granulocytopenia,
       which resolved after a lowering of zidovudine dosage. Subjective
       toxicities were mild and tolerable, and minor bleeding problems improved
       in all participants so affected. Low-dose, continuous therapy with
       interferon-alpha resulted in meaningful increases in the platelet counts
       of the majority of study participants with HIV-ITP. Interferon-alpha was
       safe and tolerable for most participants with HIV-ITP at the dosage and
       schedule employed in this study. Interferon-alpha for clinically
       significant thrombocytopenia and who have failed to respond to
       zidovudine.
 DE    Adult  Antiviral Agents/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/
       *THERAPEUTIC USE  Cohort Studies  CD4 Lymphocyte Count  CD4-Positive
       T-Lymphocytes/IMMUNOLOGY  Female  Human  HIV
       Infections/*COMPLICATIONS/IMMUNOLOGY  *HIV-1  Injections, Subcutaneous
       Interferon Alfa-2b/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/
       *THERAPEUTIC USE  Male  Platelet Count  Purpura, Thrombocytopenic,
       Idiopathic/ETIOLOGY/*THERAPY  Self Administration  Support, Non-U.S.
       Gov't  CLINICAL TRIAL  CLINICAL TRIAL, PHASE II  JOURNAL ARTICLE

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

