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M94A2855.TXT
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1994-10-25
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Document 2855
DOCN M94A2855
TI Comparative study of Ro 31-8959 and zidovudine (ZDV) vs. ZDV and
zalcitabine (ddC) vs. Ro 31-8959, ZDV, and ddC. The ACTG 229 Protocol
Team.
DT 9412
AU Collier AC; Coombs RW; Timpone J; Schoenfeld DA; Bassett R; Baruch A;
Corey L; University of Washington ACTU, Harborview Medical Center,
Seattle; 98104-2499.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):21 (abstract no. 058B). Unique
Identifier : AIDSLINE ICA10/94369720
AB OBJECTIVE: To evaluate the safety, tolerance, and antiviral efficacy of
the HIV proteinase inhibitor Ro 31-8959 and ZDV vs. ZDV and ddC vs. Ro
31-8959, ZDV and ddC. METHODS: The study was a phase II, multicenter,
double-blind, randomized, placebo-controlled study of 24 weeks duration
in patients with HIV-1, CD4+ cells 51-300/mm3 and > 4 months prior ZDV
therapy. Doses were: Ro 31-8959 600 mg TID, ZDV 200 mg TID, ddC 0.75 mg
TID, given orally. Study endpoints included CD4+ cell, HIV p24 antigen,
peripheral blood mononuclear cell HIV-1 titer, plasma viremia, and HIV
RNA trends, and toxicities. RESULTS: Three hundred and two subjects (91%
male, 9% female), mean age 38 years, with a median duration of prior
zidovudine of 25 months were enrolled. At entry, median CD4+ count was
158/mm3 and 22/155 (15%) tested to date had detectable HIV p24 antigen.
Two hundred and eighty-five (94%) subjects completed the study as of the
closure date of December 31, 1993. Of these, 37 (12%) terminated study
therapy before completing 24 weeks, with the major reason for early
discontinuation of study medication being toxicity. One hundred and
thirteen (37%) of patients had one or more adverse events, including
symptoms of disease progression and toxicity. The most common toxicities
were CPK elevation (N = 39), neutropenia (N = 16), and elevation of SGOT
(N = 12). Four patients died of AIDS related complications. Analyses of
the outcome is ongoing, and detailed results by treatment group will be
available by the summer of 1994. DISCUSSION AND CONCLUSIONS: This study
is the largest, completed, clinical trial to date of this oral HIV
proteinase inhibitor. The regimens were well tolerated, and the analysis
comparing the three regimens will be reported.
DE Adult Comparative Study Double-Blind Method Drug Therapy, Combination
Female Human HIV Protease Inhibitors/*ADMINISTRATION & DOSAGE
Isoquinolines/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Male
Quinolines/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS
Zalcitabine/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS
Zidovudine/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS CLINICAL TRIAL
CLINICAL TRIAL, PHASE II MEETING ABSTRACT MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).