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

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       protected by Copyright Law (Title 17, U.S.Code).