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).