Document 0333 DOCN M9590333 TI The safety and efficacy of sorivudine (BV-araU) for the treatment of zoster in HIV-infected adults: results of a multinational acyclovir controlled trial. DT 9509 AU Boag F; Bodsworth NJ; Burdge D; Genereux M; Barleffs JC; Evans B; Colebunders R; Modai J; Thomas M; Marcoccia J; et al; Kobler Centre, London. SO Annu Conf Australas Soc HIV Med. 1994 Nov 3-6;6:166 (unnumbered abstract). Unique Identifier : AIDSLINE ASHM6/95291766 AB Sorivudine (BV-araU) 40mg once daily was compared in a randomised double-blind trial to acyclovir 800mg five times daily for seven days for the treatment of acute localised zoster in HIV infected adults. Patients were seen daily until 100% crusting and on days 7,10,14 and 28 for assessment of lesion evolution and acute neuritis. In August 1993, accrual to the trial was stopped at 137 subjects (of a planned 160) when the second interim analysis of the first 112 patients revealed that the primary efficacy endpoint (cessation of new lesion formation) had been met at p < 0.0151 according to the stopping rules of O'Brien and Fleming. TABULAR DATA, SEE ABSTRACT VOLUME. Sorivudine treatment was also associated with less frequent analgesic use (p = 0.023) and activity impairment (p = 0.042) during the acute phase (Wei-Lachin test). All significant differences remained so following adjustment for differences in baseline variables and when only evaluable subjects (n = 113) were included. 12 month follow-up data on PHN remains blinded. Sorivudine therapy was safe and well tolerated in this population. When compared to acyclovir significant advantages were observed in time to cessation of new vesicle formation; 100% crusting; analgesia use and activity impairment. DE Acyclovir/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Adult Antiviral Agents/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Arabinofuranosyluracil/*ANALOGS & DERIVATIVES/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS AIDS-Related Opportunistic Infections/*DRUG THERAPY Comparative Study Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Herpes Zoster/*DRUG THERAPY Human Pain Measurement Treatment Outcome 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).