Document 0254
 DOCN  M9590254
 TI    The d4T Australian Parallel Track program experience. Bristol-Myers
       Squibb d4T Parallel Track Program.
 DT    9509
 AU    Mijch A; Hoy J; Chuah J; Gold J; Spelman D; Fairfield Infectious
       Diseases Hospital.
 SO    Annu Conf Australas Soc HIV Med. 1994 Nov 3-6;6:269 (unnumbered poster).
       Unique Identifier : AIDSLINE ASHM6/95291845
 AB    Since November 1992, a new antiretroviral drug, stavudine (d4T), has
       been provided to eligible patients in USA and Canada and more recently
       in Australia and Europe through the FDA endorsed Parallel Track process.
       Stavudine (d4T) is a thymidine nucleoside analogue with in-vitro
       anti-viral activity against the HIV virus. The idea of Parallel Track
       programs is to make available investigational drugs which are in late
       phase clinical trials, to a wider group of patients who cannot take part
       in formal clinical trials but for whom a benefit may be gained from the
       new therapy. Patients eligible for the d4T Parallel Track Program are
       those who have clinically significant HIV-related illness or imminent
       health risk due to HIV and are intolerant of or failing alternative
       approved antiretroviral agents. Within the program, comparative data on
       the efficacy and safety of two dose levels (approximating 0.5mg/kg/day
       and 1.0mg/kg/day) of stavudine (d4T) are being collected in a double
       blind randomised evaluation. 12 centres around Australia have had access
       to stavudine (d4T) for their HIV patients since August 1993. To June
       1994, a total of 46 patients have enrolled in the program. This
       presentation details the demographic and interim safety data for these
       first 46 patients.
 DE    Australia  Dose-Response Relationship, Drug  Double-Blind Method  Drug
       Administration Schedule  Human  HIV Infections/*DRUG THERAPY
       Stavudine/*ADMINISTRATION & DOSAGE  CLINICAL TRIAL  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).