Date: Tue, 7 May 1996 17:27:23 -0400 From: "Flynn Mclean" Subject: New Protocol Database Records 05/07/96 May 7, 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: NCI 95 C-183. TITLE: A Pilot Study of Recombinant Interleukin-2 ( IL-2 ) in Children and Adolescents With Human Immunodeficiency Virus Infection. PHASE: Pilot Study. DISEASE STATUS: Patients have the following symptoms and conditions: 1. Documented HIV infection. 2. No new or active opportunistic infection at study entry requiring acute intervention. 3. CD4 count 500-1000 cells/mm3 if 2-5 years of age or 200-500 cells/mm3 if 6 years or older. 4. Either asymptomatic with CD4 count that renders them at risk for AIDS-related opportunistic infection OR mild to moderately symptomatic. NOTE: Previously treated patients may have progressive disease or intolerance to prior therapy. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. No new or active opportunistic infection. 3. CD4 count 500-1000 cells/mm3 if 2-5 years of age or 200-500 cells/mm3 if 6 years or older. 4. Consent of parent or guardian unless over the age of consent or an emancipated minor. AGE: 02 Years - 21 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test within 14 days of study entry. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: 500 - 1000 cells/mm3. if two-five years old. ( 500 - 600 - 700 - 800 - 900 - 1000 ). OR 200 - 500 cells/mm3 if six years or older. ( 200 - 300 - 400 - 500 ). PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions are excluded: 1. Prior intolerance to AZT at 90 mg/m2 every 6 hours or ddI at 60 mg/m2 every 12 hours. 2. Prior need for therapy to maintain hemoglobin > 8.0 g/dl or neutrophils > 1000 cells/mm3 while on antiretrovirals. AGE: 01 Days - 01 Years. 22 Years - 99 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test within 14 days of study entry. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: 1. Critically ill or medically unstable. 2. Current clinical HIV disease progression on combination AZT/ddI. 3. Allergic symptoms to AZT or ddI. 4. Active peripheral neuropathy. 5. Static or progressive encephalopathy. 6. Seizure disorder. 7. Concurrent malignancy or significant autoimmune disease. 8. Concurrent participation in an HIV vaccine trial. 9. Lymphoid interstitial pneumonitis ( LIP ) requiring treatment with systemic corticosteroids. 10. Pancreatitis. GENERIC DRUG NAME ----------------- Drug 1: Aldesleukin. Immunomodulator. Drug 2: Zidovudine. Antiretroviral. Drug 3: Didanosine. Antiretroviral. DRUG TRADE NAME --------------- Drug 1: Proleukin. Drug 2: Retrovir. Drug 3: Videx. DRUG COMPANIES -------------- Drug 1: Chiron Corporation 4560 Horton Street Emeryville, CA 94608 Contact: Professional Services (510) 601-3440. Drug 2: Glaxo Wellcome 5 Moore Drive / PO Box 13398 Research Triangle Park, NC 27709 Contact: Department of Consumer Affairs (800) 437-0992 X 7900. Drug 3: Bristol - Myers Squibb Company 2400 West Lloyd Expressway Evansville, IN 47721-0001 Contact: Information (800) 662-7999. END POINT --------- Toxicity, pharmacokinetic profile. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Cessation of antiretroviral treatment. 2. Unacceptable toxicity. 3. Development of infection that delay IL-2 therapy. 4. HIV disease progression after 12 weeks of IL-2. 5. Development of malignancy that requires systemic therapy. 6. Pregnancy. 7. Patient noncompliance or desire to withdraw from study. 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. **********************************************************************