Date: Fri, 21 Feb 97 10:02:47 EST From: "David Radune" Subject: New Information from ACTIS: FDA 094 & FDA 200D February 21, 1997 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 a 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 094. TITLE: An Expanded Access Open Label Protocol of Remune (HIV-Immunogen) in HIV-1 Infected Adults With CD4 Count 550 Cells /ml and Greater DISEASE STATUS: Patients must have the following symptoms and conditions: 1. HIV-1 seropositive. 2. CD4 counts >= 550 cells/ml (or between 300 and 549 cells/ml for patients who do not qualify for ongoing Remune trials). NOTE: If a patient's CD4 count is 550 to 600 cells/ml, the patient must either rescreen within 30 days for Study 806, or wait 6 months before entering the expanded access program. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV-1 seropositive. 2. CD4 counts >= 550 cells/ml (or between 300 and 549 cells/ml for patients who do not qualify for ongoing Remune trials). NOTE: If a patient's CD4 count is 550 to 600 cells/ml, the patient must either rescreen within 30 days for Study 806, or wait 6 months before entering the expanded access program. 3. Patient must have failed or been intolerant to other comparable or alternative marketed therapies, or is not a candidate for such therapies. 4. Patient must not meet inclusion criteria for other Remune trials. 5. Patient must have laboratory tests within specified limits. [Refer to Laboratory values for additional requirements.] AGE: 18 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not breast-feeding. Negative pregnancy test. Abstinence or effective method of birth control / contraception including oral contraceptives during the study. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: >= 550 300 -549 cells/mm3. (550 - 600 - 700 - 800) (300 - 400 - 500) PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with any of the following prior conditions are excluded: Previous participation in a Remune study. [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Breast-feeding. Pregnant. No abstinence or no agreement to use effective method of birth control / contraception during the study. PRIOR MEDICATION: Excluded: 1. Previous participation in a Remune study. Excluded within 30 days of study entry: 2. Use of any immune-modulating drugs. 3. Induction therapy or initiation of new treatment regimen for an AIDS defining condition within 30 days of Day 1 visit. CONCURRENT MEDICATION: Excluded: 1. Use of any immune-modulating drugs. 2. Induction therapy or initiation of new treatment regimen for an AIDS defining condition. 3. Current participation in a Remune study. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms and conditions are excluded: 1. Clinically significant cardiac, hepatic, renal or gastrointestinal dysfunction. 2. Current participation in a Remune study. GENERIC DRUG NAME ----------------- Drug 1: HIV-1 Immunogen. Vaccine. DRUG TRADE NAME --------------- Drug 1: Remune. DRUG COMPANIES -------------- Drug 1: Immune Response Corporation 5935 Darwin Court Carlsbad, CA 92008 Contact: Trial Information (800) 684-8624. PARTICIPATING UNITS ------------------- 0000003766: The Graduate Hospital 1740 South Street Philadelphia, PA 19146 Contact: Joe Ondercin (215) 985-4448 OPEN 961001. 0000003769: ONCOL Medical Associates / PA 4140 SW Freeway Houston, TX 77027 Contact: Carol Thompson (713) 961-7100 OPEN 961001. 0000003772: Infectious Disease Physicians Incorporated 3289 Woodburn Road / Suite 140 Annandale, VA 22003 Contact: Kathy Wood (703) 560-4821 OPEN 961001. ***************************************************************** PROTOCOL NUMBER: FDA 200D. TITLE: An Open Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients with Progressive HIV Disease. PHASE: Phase III. DISEASE STATUS: Patients must have the following conditions and symptoms: 1. Patients > 18 months of age with history of positive serology for HIV-1 infection or patients <= 18 months of age with history of positive viral culture, detectable p24 antigen, or positive peripheral blood mononuclear cell macro culture. 2. Patients >= 13 years of age with a CD4+ cell count <= 200 cells/mm3 as determined by CD4+ cell count within 30 days prior to study day 0. Patients < 13 years of age with a CD4% <= 14% or a 50% decrease in CD4% in the past 6 months if the previous CD4% was >=20%. (PER AMENDMENT 1/29/97: Enrollment is closed to adults, as of Jan. 29th only pediatric patients will be enrolled). PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Patients > 18 months of age with history of positive serology for HIV-1 infection or patients <= 18 months of age with history of positive viral culture, detectable p24 antigen, or positive peripheral blood mononuclear cell macro culture. 2. Patients >= 13 years of age with a CD4+ cell count <= 200 cells/mm3. Patients < 13 years of age with a CD4% <= 14% or a 50% decrease in CD4% in the past 6 months if the previous CD4% was >=20%. 3. Patient has failed or is intolerant to currently approved treatments for HIV-1 infection and is unable to participate in a controlled viramune clinical trial. 4. Written and informed consent from a parent or guardian for patients < 18 years of age. 5. Patient or guardian is willing and able to follow protocol requirements. (PER AMENDMENT 1/29/97: Enrollment is closed to adults, as of Jan. 29th only pediatric patients will be enrolled). [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not breast-feeding. Not pregnant. Abstinence or agree to use barrier methods of birth control / contraception during the study. PRIOR MEDICATION: Required: Patient has failed or is intolerant to currently approved treatments for HIV-1 infection. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 8 g/dl. for men; >= 7.5 gm/dl for women PLATELET COUNT: >= 50000 platelets/mm3. CD4 (T4 CELL) COUNT: <= 200 cells/mm3. for >= 13 years of age; CD4% <= 14% for < 13 years of age. BILIRUBIN: <= 3 X ULN mg/dl. (ULN = Upper limit of normal) SGOT (AST): <= 7.5 X ULN. SGPT (ALT): <= 7.5 X ULN. CREATININE: <= 3 X ULN. OTHER LABORATORY VALUES: Alkaline phosphate <= 2.5 X ULN for the patient's age. Absolute neutrophil count > 700 cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] REPRODUCTIVE SPECIFICATION: Breast-feeding. Pregnant. No abstinence or no agreement to use barrier methods of birth control / contraception during the study. CONCURRENT MEDICATION: Excluded: 1. Dicumarol, Warfarin and other anticoagulant medications. 2. Tolbutamide. 3. Investigational drugs, all protease inhibitors and all other non-nucleoside transcriptase inhibitors. 4. Neurotoxic drugs. 5. Cimetidine. 6. Erythromycin. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms and conditions are excluded: Patient qualifies for participation in an actively accruing Viramune conrolled clinical trial. GENERIC DRUG NAME ----------------- Drug 1: Nevirapine. Antiretroviral. DRUG TRADE NAME --------------- Drug 1: Viramune. DRUG COMPANIES -------------- Drug 1: Boehringer Ingelheim Pharmaceuticals Incorporated 900 Ridgebury Road / PO Box 368 Ridgefield, CT 06877 Contact: Unspecified (203) 798-9988. END POINT --------- Tolerance and safety. DISCONTINUE TREATMENT --------------------- Patients may be discontinued for any of the following reasons: 1. Development of a toxicity or adverse event. 2. Continuation of study drug is medically contraindicated. 3. Patient is significantly noncompliant or wishes to withdraw from the trial. PARTICIPATING UNITS ------------------- 0000003816: Boegringer Ingelheim Pharmaceuticals Incorporated 900 Ridgebury Road / PO Box 368 Ridgefield, CT 06877 Contact: Unspecified (800) 243-7012 OPEN (Call for locations) 970131. *****************************************************************