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1996-03-04
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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).