Date: Tue, 23 Apr 1996 13:12:09 +0500 From: "Flynn Mclean" Subject: New Protocol Records 04/23/96 april 23, 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. Descriptions of the two most recent clinical trials added to the ACTIS database are 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: NIAID DATRI 022. TITLE: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3. DISEASE STATUS: Patients have the following symptoms and conditions: 1. Documented symptomatic HIV infection. 2. CD4 count 50 - 350 cells/mm3 within the past month. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Symptomatic HIV infection. 2. CD4 count 50 - 350 cells/mm3. AGE: 13 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test within 7 days of study entry. Not breast-feeding. PRIOR MEDICATION: Allowed: 1. Prior antiretrovirals (dose must be stable for at least 6 weeks prior to study entry). 2. Maintenance therapy for a chronic condition. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: 50 - 350 cells/mm3. ( 100 - 200 - 300 ). PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior condition are excluded: Change in antiretroviral therapy within past 6 weeks. AGE: 01 Days - 12 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test within 7 days of study entry. Breast-feeding. PRIOR MEDICATION: Excluded: 1. Oral IFN-alpha or other immune-based therapy within the past month. 2. Therapy for any acute disease within the past week. GENERIC DRUG NAME ----------------- Drug 1: Interferon alfa-n3. Immunomodulator. DRUG TRADE NAME --------------- Drug 1: Alferon LDO; Veldona; Ferimmune. DRUG COMPANIES -------------- Drug 1: Interferon Sciences Incorporated 783 Jersey Avenue New Brunswick, NJ 08901 Contact: Hilary Helmrich (908) 249-3250. END POINT --------- Response as determined by changes in symptom burden. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Unacceptable toxicity. 2. Pregnancy. 3. Desire of patient to withdraw from study. PARTICIPATING UNITS ------------------- 0000003523: King - Drew Medical Center 12021 South Wilmington Avenue / OASIS Clinic Los Angeles, CA 90059 Contact: Laurie Tolbert (310) 668-4213 OPEN 960418. 0000003296: AIDS Community Research Consortium 1048 El Camino Real Redwood City, CA 94063 Contact: Brian Camp (415) 364-6563 OPEN 960418. 0000003509: Georgetown University Medical Center 3800 Reservoir Road NW / Kober - Cogan Building Washington, DC 20007 Contact: Irene Scanlon RN (202) 687-1079 Contact: (202) 687-2291 OPEN 960418. 0000003524: Abundant Life Clinic Foundation 3708 Hayes Street NW / Suite 101 Washington, DC 20019 Contact: Carol Fleary (202) 397-4000 OPEN 960418. 0000003526: Howard University Hospital 2112 Georgia Avenue Washington, DC 20059 Contact: Yvette Butler (202) 806-4200 OPEN 960418. 0000003528: Medical Center of Delaware / Wilmington Hospital 501 West 14th Street Wilmington, DE 19801 Contact: Karen Swanson (302) 428-2538 OPEN 960418. 0000001785: Henry Ford Hospital 2799 West Grand Boulevard Detroit, MI 48202 Contact: Diane Mastro-Polak (313) 876-2798 Contact: (313) 876-7644 OPEN 960418. 0000003527: University of Minnesota Hospital 420 Delaware Street Minneapolis, MN 55455 Contact: Carol Kumekawa (612) 625-1462 OPEN 960418. 0000003525: Dr Barbara Justice 457 West 141st Street New York, NY 10031 Contact: Angelo Crespo (212) 926-8557 OPEN 960418. 0000001714: Harlem Hospital Center 506 Lenox Avenue New York, NY 10037 Contact: Luis Fuentes (212) 939-4170 OPEN 960418. 0000003522: New York Medical College / Westchester County Medical Center Macy Pavilion / Room 209SE Valhalla, NY 10595 Contact: Kathleen O'Keefe (914) 285-7400 OPEN 960418. 0000002844: SUNY / Health Sciences Center at Brooklyn 450 Clarkson Avenue / Box 77 Brooklyn, NY 11203 Contact: Donald Smith (718) 270-3370 Contact: (718) 270-3372 OPEN 960418. 0000003356: University of Pennsylvania Medical Center 37th and Hamilton Walk / 536 Johnson Pavilion Philadelphia, PA 19104 Contact: Beth Kaniefski (215) 662-2473 OPEN 960418. 0000003529: Meharry Medical College 1005 D B Todd Boulevard Nashville, TN 37208 Contact: Pamela Emmons (615) 327-5830 OPEN 960418. ***************************************************************** PROTOCOL NUMBER: NCI 96 C-3. TITLE: A Phase I/II Study of the Protease Inhibitor Ritonavir ( ABT-538 ) in Children With HIV Infection. PHASE: Phase I / Phase II. DISEASE STATUS: Patients have the following symptoms and conditions: HIV infection. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: HIV infection. AGE: 06 Months - 21 Years. SEX: M. F. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: Unspecified cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- AGE: 01 Days - 05 Months. 22 Years - 99 Years. GENERIC DRUG NAME ----------------- Drug 1: Ritonavir. Protease inhibitor. Drug 2: Zidovudine. Antiretroviral. Drug 3: Didanosine. Antiretroviral. DRUG TRADE NAME --------------- Drug 2: Retrovir. Drug 3: Videx. DRUG COMPANIES -------------- Drug 1: Abbott Laboratories One Abbott Park Road Abbott Park, IL 60064 Contact: Ritonavir Information (800) 441-4987. Drug 2: Burroughs Wellcome 3030 Cornwallis Road Research Triangle Park, NC 27709 Contact: Drug Information (800) 443-6763. Drug 3: Bristol - Myers Squibb Company 2400 West Lloyd Expressway Evansville, IN 47721-0001 Contact: Information (800) 662-7999. PARTICIPATING UNITS ------------------- 0000001821: National Cancer Institute 9000 Rockville Pike / Clinical Center Bethesda, MD 20892 Contact: Susan Sandelli (301) 402-1391 Contact: (301) 402-1387 OPEN / USA accrual 951201. *****************************************************************