Date: Thu, 25 Apr 1996 15:58:22 -0400 From: "Flynn Mclean" Subject: New Protocol Records 04/25/96 April 25, 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: NCI 95 C-144. TITLE: Pilot Study of the Combination of Tretinoin ( All-trans-Retinoic Acid ) and Interferon alfa-2a ( IFN alfa-2a ) for the Treatment of Lymphoproliferative Disorders in Children With Immunodeficiency Syndromes. PHASE: Pilot Study. DISEASE STATUS: Patients have the following symptoms and conditions: Lymphoproliferative disorder as a consequence of HIV infection, as part of another immunodeficiency, or post-transplant. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: Lymphoproliferative disorder. AGE: 01 Days - 17 Years. SEX: M. F. CONCURRENT MEDICATION: Required in HIV-infected patients: Concurrent approved antiretroviral therapy. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: Unspecified cells/mm3. GENERIC DRUG NAME ----------------- Drug 1: Tretinoin. Keratolytic. Drug 2: Interferon alfa-2a. Immunomodulator. DRUG COMPANIES -------------- Drug 1: Drugs are provided by each participating unit site . Drug 2: Drugs are provided by each participating unit site . 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. *********************************************************************** PROTOCOL NUMBER: NCI 95 C-163. TITLE: Phase I/II Study of the Protease Inhibitor Indinavir Sulfate ( MK-639 ) in Children With HIV Infection. PHASE: Phase I / Phase II. DISEASE STATUS: Patients have the following symptoms or 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: Indinavir sulfate. Protease inhibitor. Drug 2: Zidovudine. Antiretroviral. Drug 3: Lamivudine. Antiretroviral. DRUG TRADE NAME --------------- Drug 1: Crixivan. Drug 2: Retrovir. Drug 3: 3TC. DRUG COMPANIES -------------- Drug 1: Merck Research Laboratories 126 East Lincoln Avenue Rahway, NJ 07065 Contact: Unspecified (800) 379-1332 Contact: Dr Paul Beutsch (908) 594-5833. Drug 2: Burroughs Wellcome 3030 Cornwallis Road Research Triangle Park, NC 27709 Contact: Drug Information (800) 443-6763. Drug 3: Glaxo Incorporated 5 Moore Drive Research Triangle Park, NC 27709 Contact: Jennifer McMillan (919) 248-2100. 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. *********************************************************************