Date: Wed, 19 Feb 97 13:16:13 EST From: "David Radune" Subject: New Information from ACTIS: NIAID CPCRA 039 February 19, 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 039. TITLE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil (bis-POM PMEA) in Prolonging Survival of HIV-Infected Individuals With a CD4+ Cell Count of <= 100/mm3. PHASE: Phase III. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. A working diagnosis of HIV infection based on the patients's medical history, behavioral history, clinical signs and symptoms, or results of other laboratory tests. 2. CD4+ cell count <= 100 cells/mm3 within 60 days prior to randomization. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1.HIV infection. 2. CD4+ cell sount <= 100 cells/mm3. 3. Reasonably good health. 4. Life expectancy of at least 6 months. 5. Access to a refrigerator for the storage of adefovir dipivoxil. 6. Signed informed consent from parent or legal guardian for patients less than 18 years of age. [Refer to Laboratory values for additional requirements.] AGE: 13 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not breast-feeding. Not pregnant. CONCURRENT MEDICATION: Allowed: 1. Chronically administered concomitant therapies for HIV and opportunistic diseases, including chemotherapy for cutaneous Kaposi's sarcoma, must be on these therapies for at least 30 days prior to study entry. 2. Short courses of oral antibiotics or other therapies given for a limited period of 3 weeks. 3. Episodic use of IV acyclovir or oral acyclovir > 1g/day for treatment of acute illness is permitted at the clinician's discretion. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 8 g/dl. PLATELET COUNT: >= 50000 platelets/mm3. CD4 (T4 CELL) COUNT: <= 100 cells/mm3. (0 - 100) SGOT (AST): <= 5 X ULN. (ULN = Upper limit of normal) SGPT (ALT): <= 5 X ULN. CREATININE: <= 1.5 mg/dl. KARNOFSKY: >= 60. OTHER LABORATORY VALUES: Absolute neutrophil count >= 750/mm3. Amylase <= 2 X ULN. For patients enrolled in the safety-virology cohort: CMV serology (IgG) positive. For patients not enrolled in the safety-virology cohort: CMV serology (IgG) positive, or CMV serology (IgG) negative test result within 30 days prior to randomization. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions are excluded: History of CMV end organ disease. [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Breast-feeding. Pregnant. PRIOR MEDICATION: Excluded within 2 weeks of randomization: 1. Any investigational anti-CMV agent. 2. Adenine arabinoside (vidarabine). 3. Amantadine hydrochloride (Symmetrel). 4. Cidofovir (Vistide). 5. CMV hyperimmune globulin. 6. Cytosine arabinoside (cytarabine). 7. Famciclovir. 8. Foscarnet (phosphonoformic acid). 9. Ganciclovir (Cytovene). 10. GW 1263W94 (Benzamidazole). 11. Idoxuridine. 12. Intravenous acyclovir. 13. ISIS 2922 (Anti-sense). 14. Lobucavir. 15. MSL109. 16. Oral acyclovir > 1 g/day. 17. Valaciclovir. CONCURRENT MEDICATION: Excluded: 1. Any investigational anti-CMV agent. 2. Adenine arabinoside (vidarabine). 3. Amantadine hydrochloride (Symmetrel). 4. Cidofovir (Vistide). 5. CMV hyperimmune globulin. 6. Cytosine arabinoside (cytarabine). 7. Famciclovir. 8. Foscarnet (phosphonoformic acid). 9. Ganciclovir (Cytovene). 10. GW 1263W94 (Benzamidazole). 11. Idoxuridine. 12. Intravenous acyclovir. 13. ISIS 2922 (Anti-sense). 14. Lobucavir. 15. MSL109. 16. Oral acyclovir > 1 g/day. 17. Valaciclovir. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms and conditions are excluded: 1. Evidence of active CMV disease at screening. 2. Conditions that would require use of medications listed in exclusion concurrent medications. GENERIC DRUG NAME ----------------- Drug 1: Adefovir dipivoxil. Antiretroviral. Drug 2: Levocarnitine. Antihyperlipoproteinemic. DRUG TRADE NAME --------------- Drug 2: L-carnitine. DRUG COMPANIES -------------- Drug 1: Gilead Sciences Incorporated 353 Lakeside Drive Foster City, CA 94404 Contact: Medical Information (800) 445-3235. Drug 2: Gilead Sciences Incorporated 353 Lakeside Drive Foster City, CA 94404 Contact: Medical Information (800) 445-3235. END POINT --------- Death, unacceptable toxicity and progression of disease. DISCONTINUE TREATMENT --------------------- Patients may be discontinued for any of the following reasons: Temporary Discontinuation 1. Pregnancy. 2. Breastfeeding. 3. Drug toxicity requiring discontinuation of adefovir dipivoxil. 4. Temporary discontinuation of L-carnitine. Permanent Discontinuation 5. Intercurrent illness which, in the judgement of the clinician, would affect assessments of clinical status to a significant degree. 6. Drug toxicity requiring permanent discontinuation of adefovir dipivoxil. 7. Permanent discontinuation of L-carnitine. 8. Patient and/or physician request. 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 961230. 0000001933: Denver Public Health Department 605 Bannock Street Denver, CO 80204-4507 Contact: Jack Rouff (303) 436-7184 OPEN 961230. 0000001919: George Washington University Medical Center 2150 Pennsylvania Avenue NW Washington, DC 20037 Contact: Charlotte Quinlan (202) 994-3076 OPEN 970123. 0000001916: Veterans Administration Medical Ctr / Regional AIDS Program 50 Irving Street NW / Room 151B Washington, DC 20422 Contact: Barbara Standridte (202) 745-8695 OPEN 970123. 0000001870: AIDS Research Consortium of Atlanta 131 Ponce de Leon Avenue / Suite 130 Atlanta, GA 30308 Contact: Terri Creagh (404) 876-2317 OPEN 961231. 0000001864: AIDS Research Alliance - Chicago 711 West North Avenue / Suite 201 Chicago, IL 60610 Contact: Rita Verheggen (312) 266-0227 OPEN 970205. 0000003677: AIDS Research Alliance - Chicago 2800 North Sheridan Road / Suite 108 Chicago, IL 60657 Contact: Rita Verheggen (773) 244-5800 OPEN 970102. 0000001785: Henry Ford Hospital 2799 West Grand Boulevard Detroit, MI 48202 Contact: Diane Mastro-Polak (313) 876-2798 Contact: (313) 876-7644 OPEN 970128. 0000003345: Community Research Initiative of North Jersey 393 Central Avenue / Suite 301 Newark, NJ 07103 Contact: Vicki Taylor (201) 483-3444 OPEN 961220. 0000003376: Southern New Jersey AIDS Clinical Trials 3 Cooper Plaza / Suite 220 Camden, NJ 08103 Contact: Maryann LiVolsi (609) 963-6890 OPEN 970106. 0000001714: Harlem Hospital Center 506 Lenox Avenue New York, NY 10037 Contact: Luis Fuentes (212) 939-4170 OPEN 970108. 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 970109. 0000003324: Philadelphia FIGHT 201 North Broad Street / 6th Floor Philadelphia, PA 19107 Contact: Carol Graeber (215) 557-8265 OPEN 970204. ******************************************************************