Date: Fri, 28 Jun 1996 15:45:11 -0400 From: "Flynn Mclean" Subject: New Protocol Records 06/28/96 June 28, 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: NIAID ACTG 285. TITLE: A Pilot Study of Stem Cell Mobilization and Harvesting From the Peripheral Blood Using Filgrastim. PHASE: Pilot Study. DISEASE STATUS: Patients have the following symptoms and conditions: 1. HIV infected or uninfected. 2. HIV infected patients with CD4 count > 500 cells/mm3 must be asymptomatic. Patients with CD4 count 200-500 cells/mm3 may be either asymptomatic or symptomatic but must not have AIDS. Patients with CD4 count < 200 cells/mm3 may or may not have AIDS-defining conditions. 3. No antiretroviral therapy within the past 30 days in patients with CD4 count > 500 cells/mm3. 4. Stable antiretroviral therapy for the past 60 days in patients with CD4 count <= 500 cells/mm3. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. HIV infected patients with CD4 count > 500 cells/mm3 must be asymptomatic. Patients with CD4 count 200-500 cells/mm3 may be either asymptomatic or symptomatic but must not have AIDS. Patients with CD4 count < 200 cells/mm3 may or may not have AIDS-defining conditions. 3. No antiretroviral therapy within the past 30 days in patients with asymptomatic disease and CD4 count > 500 cells/mm3. 4. Stable antiretroviral therapy for the past 60 days if CD4 count <= 500 cells/mm3. 5. Suitable venous access. AGE: 18 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test within 14 days of study entry. Abstinence or agree to use barrier methods of birth control / contraception during the study. PRIOR MEDICATION: Allowed: Prior antiretroviral therapy. CONCURRENT MEDICATION: Allowed: 1. PCP prophylaxis. 2. Antiretroviral therapy in patients with CD4 counts <= 500 cells/mm3. 3. Narcotic analgesics for grade 3/4 bone pain toxicity. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 9.1 g/dl. (men); >= 8.8 g/dl (women). Transfusion or ongoing erythropoietin not allowed. PLATELET COUNT: >= 75000 platelets/mm3. CD4 (T4 CELL) COUNT: Unspecified cells/mm3. SGOT (AST): <= 5 x ULN. (ULN = upper limit of normal). CREATININE: <= 1.5 x ULN. KARNOFSKY: >= 70. OTHER LABORATORY VALUES: Absolute neutrophils >= 1000 cells/mm3 without G-CSF. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions are excluded: 1. Prior malignancy. 2. Leukapheresis or lymphopheresis within the past 180 days. 3. Significant active CNS disease or seizures within the past year. AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test within 14 days of study entry. No abstinence or no agreement to use barrier methods of birth control / contraception during the study. RISK BEHAVIOR: Active alcohol or substance abuse. CONCURRENT TREATMENT: Excluded: Systemic radiation therapy. PRIOR MEDICATION: Excluded: 1. G-CSF or GM-CSF within the past 6 months. 2. Investigational antiretrovirals within the past 30 days. 3. Treatment for opportunistic infection within the past 14 days. CONCURRENT MEDICATION: Excluded: 1. Acute treatment for serious opportunistic infection. 2. Systemic cytotoxic chemotherapy. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: 1. Current malignancy. 2. Any medical condition that interferes with study evaluation. 3. Known hypersensitivity to E. coli-derived proteins (e.g., insulin, human growth hormones). GENERIC DRUG NAME ----------------- Drug 1: Filgrastim. Hematopoietic stimulant. DRUG TRADE NAME --------------- Drug 1: Neupogen. DRUG COMPANIES -------------- Drug 1: Amgen Incorporated 1840 Dehavilland Drive Thousand Oaks, CA 91320-1789 Contact: Roberta Wong (805) 447-8762. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Unacceptable toxicity. 2. Pregnancy. 3. Debilitation due to disease progression that precludes further participation on study. 4. Further participation deemed detrimental to well-being. 5. Study noncompliance or refusal of further treatment. 6. Requirement for prohibited medications. PARTICIPATING UNITS ------------------- 0000002265: University of Colorado Health Sciences Center 4200 East 9th Avenue / Colorado ACTU / Campus Box B-163 Denver, CO 80262 Contact: M Graham Ray (303) 372-5535 OPEN 960320 ACTU: 6101. *********************************************************************