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M94A3011.TXT
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1994-10-25
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Document 3011
DOCN M94A3011
TI A randomized trial of 2 doses of alpha interferon (IFN) added to AZT for
the treatment of Kaposi's sarcoma.
DT 9412
AU Beaulieu R; Shepherd F; Murphy K; Gelmon K; Thuot C; Sawka C; Singer J;
Canadian HIV Trials Network.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):174 (abstract no. PB0122). Unique
Identifier : AIDSLINE ICA10/94369564
AB OBJECTIVES: Moderate to high-dose IFN induces clinical response in up to
40% of pts with KS, but, pts require frequent dose reduction or
discontinuation of treatment for toxicity, and high dose IFN may not be
given concurrently with AZT. This study was undertaken to compare the
efficacy and toxicity of IFN 8MU s.c./day or 1MU s.c./day added to AZT
100 mg p.o. q 4 h while awake (500 mg/day). METHODS: Pts had to be
HIV+ve with bx-proven or unequivocal clinical KS and free from active
opportunistic infection (OI). They had to have adequate hematology (Hgb
> or = 90 g/L, granulocytes > or = 1 x 10(9)/L, platelets > or = 130 x
10(9)/L) and adequate hepatic function (transaminases < or = to 2 x
normal). In the absence of drug toxicity, OI or KS progression, pts were
to remain on study for 4 cycles (16 wks). They were assessed monthly
while on IFN and every 3 mo post-therapy. Response was judged on lesion
number +/- size, +/- flattening. Between Oct. '90 and Feb. '93, 118 pts
(117 male) were randomized. RESULTS: The overall response rate (CR+PR)
was higher in the 8MU than the 1MU group (29% vs 15%; p = 0.07) with a
shorter mean time to onset of response (2.94 mo vs 5.9 mo; p = 0.004)
and longer response duration (7.13 mo vs 2.86 mo; p = 0.03). More pts on
8MU required interruption or reduction of IFN for adverse events
(hematologic 17 vs 7; liver dysfunction 4 vs 2; flu-like symptoms 13 vs
4). Only 10 pts completed 4 mo of IFN 8MU/day without needing dose
reduction. CONCLUSION: In summary IFN 8MU/day may be combined safely
with AZT 500 mg/day, and results in a higher rate of response of more
rapid onset, and longer duration than low dose IFN.
DE Acquired Immunodeficiency Syndrome/*THERAPY Administration, Oral Adult
Combined Modality Therapy Comparative Study Dose-Response
Relationship, Drug Drug Administration Schedule Female Human
Injections, Subcutaneous Interferons/*ADMINISTRATION & DOSAGE/ADVERSE
EFFECTS Male Sarcoma, Kaposi's/*THERAPY Support, Non-U.S. Gov't
Zidovudine/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS CLINICAL TRIAL
MEETING ABSTRACT RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).