Date: Thu, 20 Feb 97 11:29:41 EST From: "David Radune" Subject: New Information from ACTIS: NIAID CPCRA 041 & FDA 093 February 20, 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: NIAID CPCRA 041. TITLE: A Randomized Trial of Immediate Versus Deferred Indinavir in Addition to Background Antiretroviral Therapy in HIV-Infected Patients With CD4+ Cell Counts Between 200 and 500/mm3 and Plasma HIV RNA Levels >= 10,000 Copies/mL DISEASE STATUS: Patients must have the following symptoms and conditions: 1. A working diagnosis of HIV infection based on their medical history, behavioral history, clinical signs and symptoms, or results of other laboratory tests. 2. A CD4+ count between 200 and 500 cells/mm3 within 45 days prior to randomization. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. A working diagnosis of HIV infection. 2. A CD4+ count between 200 and 500 cells/mm3. 3. Signed, informed parental consent if patient is less than 18. NOTE: The DAIDS Clinical Science Committee (CSRC) has deemed this protocol appropriate for prisoner enrollment. [Refer to Laboratory values for additional requirements.] AGE: 16 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not breast-feeding. Not pregnant. Negative pregnancy test. Abstinence or agree to use barrier methods of birth control / contraception during the study. CONCURRENT MEDICATION: Allowed: 1. Topical and/or antifungal agents, except ketoconazole. 2. Treatment, maintenance, or chemoprophylaxis with approved agents for OIs will be given as clinically indicated. 3. Clinically indicated antibiotics, unless excluded. 4. Systemic corticosteroid use for <21 days for acute problems is permitted as clinically indicated. However, chronic systemic corticosteroid use should be avoided. 5. Recombinant erythropoietin (rEPO) and granulocyte-colony stimulating factor (G-CSF, filgastrim). 6. Didanosine (ddI). 7. Regularly prescribed medications, such as antipyretics, antidepressants, oral contraceptives, megestrol acetate, testosterone, or any other medication. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: 200 - 500 cells/mm3. (200 - 300 - 400 - 500) BILIRUBIN: <= 2.5 mg/dl. CREATININE: <= 2.5 mg/dl. OTHER LABORATORY VALUES: Plasma HIV RNA level >= 10000 copies/ml PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with any of the following prior conditions are excluded: 1. History of prior saquinavir (SQV) therapy for more than 14 days. 2. History of any prior protease inhibitor therapy other than SQV. 3. History of serious opportunistic infection. [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Breast-feeding. Pregnant. Positive pregnancy test. No abstinence or no agreement to use barrier methods of birth control / contraception during the study. CONCURRENT MEDICATION: Excluded: 1. Nonnucleoside reverse transcriptase inhibitors. 2. Protease inhibitors except IDV. 3. Rifabutin and rifampin. 4. Ketoconazole. 5. Terfenadine, astemizole, cisapride, triazolam and midazolam. 6. NNRTIs. CO-EXISTING CONDITIONS OR DISEASES: Patients with any of the following conditions or symptoms are excluded: 1. Febrile illness with temperature > 38.5 degrees C (101.3 degrees F) within 3 days prior to study entry. GENERIC DRUG NAME ----------------- Drug 1: Indinavir sulfate. Protease inhibitor. DRUG COMPANIES -------------- Drug 1: Merck and Company Incorporated Professional Services West Point, PA 19486 Contact: Professional Information (215) 661-7300 Contact: Prof Info / Call Collect (215) 652-3298. END POINT --------- Time to disease progression or death, survival and unacceptable toxicity. DISCONTINUE TREATMENT --------------------- Patients may be discontinued from the study for any of the following reasons: Temporary Discontinuation: 1. Patient develops a study drug toxicity. 2. Patient requires treatment for an acute opportunistic infection, acute bacterial infection or opportunistic malignancy. Permanent Discontinuation: 3. Patient develops a toxicity severe enough to warrant permanent discontinuation. 4. Patient reaches a switchpoint, but has exhausted switchover alternatives. 5. Patient refuses further therapy. 6. Primary physician judges that it is no longer in the patient's best interest to continue study therapy. 7. Pregnancy. 8. Termination of the study. PARTICIPATING UNITS ------------------- 0000002072: Community Consortium of San Francisco 3180 18th Street / Suite 201 San Francisco, CA 94110 Contact: Carroll C Child (415) 476-5433 OPEN 961211. 0000001933: Denver Public Health Department 605 Bannock Street Denver, CO 80204-4507 Contact: Jack Rouff (303) 436-7184 OPEN 961211. 0000001916: Veterans Administration Medical Ctr / Regional AIDS Program 50 Irving Street NW / Room 151B Washington, DC 20422 Contact: Barbara Standridte (202) 745-8695 OPEN 961210. 0000001870: AIDS Research Consortium of Atlanta 131 Ponce de Leon Avenue / Suite 130 Atlanta, GA 30308 Contact: Terri Creagh (404) 876-2317 OPEN 961213. 0000001864: AIDS Research Alliance - Chicago 711 West North Avenue / Suite 201 Chicago, IL 60610 Contact: Rita Verheggen (312) 266-0227 OPEN 961202. 0000001859: Louisiana Community AIDS Research Program 1430 Tulane Avenue / HC28 New Orleans, LA 70112 Contact: Janice Walker (504) 584-1971 OPEN 970124. 0000001785: Henry Ford Hospital 2799 West Grand Boulevard Detroit, MI 48202 Contact: Diane Mastro-Polak (313) 876-2798 Contact: (313) 876-7644 OPEN 970204. 0000003345: Community Research Initiative of North Jersey 393 Central Avenue / Suite 301 Newark, NJ 07103 Contact: Vicki Taylor (201) 483-3444 OPEN 961211. 0000003376: Southern New Jersey AIDS Clinical Trials 3 Cooper Plaza / Suite 220 Camden, NJ 08103 Contact: Maryann LiVolsi (609) 963-6890 OPEN 961203. 0000001714: Harlem Hospital Center 506 Lenox Avenue New York, NY 10037 Contact: Luis Fuentes (212) 939-4170 OPEN 961230. 0000001657: Portland Veterans Adm Medical Center / Rsch & Education Grp 2701 Northwest Vaughn Street / Suite 840 Portland, OR 97210-9951 Contact: Robert Forrest (503) 229-8428 OPEN 961220. 0000002215: Richmond AIDS Consortium PO Box 980049 Richmond, VA 23298 Contact: Susan DePew (804) 828-6471 OPEN 970128. ***************************************************************** PROTOCOL NUMBER: FDA 093. TITLE: An Expanded Access Open Label, Compassionate Use Protocol of Remune in HIV-1 Infected Adults With CD4 Count Less Than 300 cells/ml. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. HIV-1 seropositive. 2. CD4 counts < 300 cells/ml. NOTE: If a patient's CD4 count is 275 to 300 cells/ml, the patient must either rescreen 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 < 300 cells/ml. NOTE: If a patient's CD4 count is 275 to 300 cells/ml, the patient must either rescreen 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: < 300 cells/mm3. (0 - 100 - 200 - 300) PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with any of the following prior conditions are excluded: 1. 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. Use of any immune-modulating drugs within 3 months of day 1 visit. 2. 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. 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. *****************************************************************