Date: Wed, 20 Mar 1996 13:42:09 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: New Protocol Database Records 03/20/96 March 20, 1996 NEW INFORMATION FROM ACTIS The AIDS Clinical Trials Information Service (ACTIS) is a central resource providing current information on federally and privately sponsored clinical trials for AIDS patients and others infected with HIV. This service is a Public Health Service project produced collaboratively by the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases, and the National Library of Medicine. NAC ONLINE, the computerized information service of the CDC National AIDS Clearinghouse, will alert you to any new information collected by ACTIS. A description of the most recent clinical trial added to the ACTIS database is provided below. For more information, call the ACTIS toll-free number to talk with a health specialist. On request, you can also obtain a printout of a customized search of the clinical trials databases. The information can also be accessed directly by subscribers through two online databases, AIDSTRIALS and AIDSDRUGS, available through the National Library of Medicine. AIDS CLINICAL TRIALS INFORMATION SERVICE 1-800-TRIALS-A (1-800-874-2572) FAX: 1-301-738-6616 TTY/TDD: 1-800-243-7012 International Line: 1-301-217-0023 ***************************************************************** PROTOCOL NUMBER: FDA 255A. TITLE: Treatment of Pediatric HIV-Infected Patients With Cutaneous, Visceral, or Ocular Varicella-Zoster Viral Disease Who Have Failed or Are Intolerant of Standard Therapy. (Participation is available through personal physician.) PHASE: Phase III. DISEASE STATUS: Patients have the following symptoms and conditions: 1. HIV infection. 2. Clinical history consistent with cutaneous, visceral, or ocular varicella-zoster virus disease. 3. VZV infection documented within 7 days prior to study entry. 4. Failed or intolerant of acyclovir or foscarnet therapy. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. Cutaneous, visceral, or ocular varicella-zoster viral infection. 3. Refractory or intolerant to acyclovir or foscarnet therapy. 4. Consent or parent or guardian. AGE: 02 Years - 17 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test within 2 days of study entry. Abstinence or effective method of birth control / contraception including oral contraceptives during the study. PRIOR MEDICATION: Required: Prior acyclovir or foscarnet. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: Unspecified cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior condition are excluded: History of immediate hypersensitivity to nucleoside analogues. AGE: 01 Days - 01 Years. 18 Years - 99 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test within 2 days of study entry. No abstinence or no agreement to use effective method of birth control/contraception during the study. PRIOR MEDICATION: Excluded: 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry. CONCURRENT MEDICATION: Excluded: 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: Inability to take oral capsules or tolerate liquids. GENERIC DRUG NAME ----------------- Drug 1: Sorivudine. Antiviral. DRUG COMPANIES -------------- Drug 1: Bristol - Myers Squibb Company 5 Research Parkway Wallingford, CT 06492 Contact: Scott Oshana (203) 284-7658. PARTICIPATING UNITS ------------------- 0000002708: Bristol - Myers Squibb Company 5 Research Parkway Wallingford, CT 06492 Contact: Scott Oshana (203) 284-7658 OPEN / USA accrual 960208. ******************************************************************