Date: Fri, 28 Feb 97 11:19:20 EST From: "David Radune" Subject: New Information from ACTIS: FDA 200E February 28, 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 200E. TITLE: An International, Double Blind, Randomized, Phase III Study to Evaluate the Tolerance, Safety, and Effectiveness of Viramune (Nevirapine) in Preventing Clinical AIDS Progression Events or Death When Used in Combination With Lamivudine (3TC) and Stable (>= 4 weeks) Background Nucleoside Therapy. PHASE: Phase III. DISEASE STATUS: Patients must have the following conditions and symptoms: 1. HIV infection documented by ELISA and confirmed by Western Blot or positive HIV-1 culture, antigen or HIV-1 RNA test. 2. CD4+ cell count <= 200 cells/mm33. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Documented HIV infection. 2. CD4+ cell count <= 200 cells/mm33. 3. Life expectancy > 3 months. 4. Written informed consent from parent or guardian for patients < 18 years of age. 5. Willingness and ability to follow protocol requirements. [Refer to Laboratory values for additional requirements.] AGE: 13 Years - 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 must be receiving stable nucleoside therapy with at least one agent for >= 4 weeks prior to study day 0. Zidovudine (ZDV), Zidovudine + Dideoxycytidine (ddC), or Zidovudine + Didanosine (ddI) must be used unless prior intolerance precludes ZDV use. Stable use means no change in dose > 50% for any background nucleoside within four weeks prior to study day 0. NOTE: If patient is ZDV intolerant, ddC, ddI or D4T monotherapy is allowed. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 9.5 g/dl. for men; >= 9.0 g/dl for women. PLATELET COUNT: >= 50000 platelets/mm3. CD4 (T4 CELL) COUNT: <= 200 cells/mm3. (0 - 100 - 200) BILIRUBIN: <= 1.5 X ULN mg/dl. (ULN = Upper limit of normal) SGOT (AST): <= 3 X ULN. SGPT (ALT): <= 3 X ULN. CREATININE: <= 1.5 X ULN. KARNOFSKY: >= 70. OTHER LABORATORY VALUES: Alkaline Phosphatase <= 2.5 X ULN for the patient's age. Absolute Neutrophil Count >= 1000 cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with any of the following prior conditions and symptoms are excluded: History of clinically important disease other than HIV-1 infection or related diseases that, in the opinion of the investigator, may put the patient at risk because of participation in this 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 barrier methods of birth control / contraception during the study. RISK BEHAVIOR: Excluded: Patient's who are active chronic alcohol or substance abusers or have an active psychiatric condition sufficient to impair compliance with protocol requirements. CONCURRENT TREATMENT: Excluded: Radiation therapy. PRIOR MEDICATION: Excluded: 1. Patient has received prior therapy with Viramune or any other non-nucleoside reverse transcriptase inhibitor. 2. Patient has received any immunosuppressive or cytotoxic drugs or any other experimental agent within 4 weeks prior to study day 1. 3. Patient has received treatment with erythromycin, coumadin/warfarin, phenobarbital, amoxyicillin/clavulanic acid, or ticarcillin/clavulanic acid within 2 weeks prior to study day 0. CONCURRENT MEDICATION: Excluded: 1. Patient is receiving therapy with an antiretroviral agent other than ZDV, d4T, ddI, ddC, or 3TC. 2. Patient is receiving acute therapy for a clinical AIDS progression event such as systemic chemotherapy. 3. Dicumarol, Warfarin and other anticoagulant medications. 4. Tolbutamide. 5. Investigational drugs (unless included in opportunistic infection clinical trial) and all antiretroviral agents (excluding ZDV, ddC, ddI, d4T and 3TC). 6. Neurotoxic drugs. 7. Cimetidine. 8. Erythromycin. CO-EXISTING CONDITIONS OR DISEASES: Patients with any of the following conditions or symptoms are excluded: Patient is enrolled or plans enroll during the course of this study in another clinical study of an antiretroviral or other agent used to treat HIV-1 infection. NOTE: Patients are allowed to participate in opportunistic infection clinical studies if the investigational agent is not contraindicated for the study. GENERIC DRUG NAME ----------------- Drug 1: Nevirapine. Antiretroviral. Drug 2: Lamivudine. Antiretroviral. DRUG TRADE NAME --------------- Drug 1: Viramune. Drug 2: 3TC. DRUG COMPANIES -------------- Drug 1: Boehringer Ingelheim Pharmaceuticals Incorporated 900 Ridgebury Road / PO Box 368 Ridgefield, CT 06877 Contact: Unspecified (203) 798-9988. Drug 2: Glaxo Wellcome 5 Moore Drive / PO Box 13398 Research Triangle Park, NC 27709 Contact: Dept. of Consumer Affairs (800) 437-0992 X 7900. END POINT --------- First occurence of a confirmed clinical AIDS progression event or death. DISCONTINUE TREATMENT --------------------- Patients may be discontinued for any of the following reasons: 1. Patient refuses to participate further. 2. Patient is lost to follow-up. 3. Subsequent follow up of the patient is impossible (i.e., patiente died). PARTICIPATING UNITS ------------------- 0000003777: Drug Research and Analysis Corporation 303 South Ripley Street / Number 11 Montgomery, AL 36104 Contact: Carolyn Stanley (334) 265-2700 OPEN 970130. 0000003021: Dr G Michael Wool 2080 Century Park East / Century City Plaza / Suite 1006 Los Angeles, CA 90067 Contact: Andrew Miranda (310) 556-7991 OPEN 970130. 0000003791: UCLA School of Medicine / Center for Research and Education 10833 Le Conte / BH - 412 CHS Los Angeles, CA 90095 Contact: Margrit Carlson (310) 206-6414 OPEN 970130. 0000002720: Harbor - UCLA Medical Center 1124 West Carson Street / Building N-24 Torrance, CA 90502 Contact: Sally Kruger (310) 222-2365 OPEN 970130. 0000003296: AIDS Community Research Consortium 1048 El Camino Real Redwood City, CA 94063 Contact: Lori Greulich (415) 364-6563 OPEN 970130. 0000003798: ViRx Incorporated 1375 Sutter Street / Suite 407 San Francisco, CA 94109 Contact: Teri Galindo (415) 474-4440 OPEN 970130. 0000003794: San Francisco General Hospital / AIDS Program 995 Potrero Avenue / Building 80 / Ward 84 San Francisco, CA 94110 Contact: Anne Smith (415) 476-4082 X 84150 OPEN 970130. 0000003792: AIDS Research Center / Palo Alto VA Health Care System 3801 Miranda / Mail Code 111 - 1D Palo Alto, CA 94304 Contact: Unspecified (415) 493-5000 X x64694 OPEN 970130. 0000003809: Denver Public Health 605 Bannock Denver, CO 80204 Contact: Unspecified (303) 436-7000 OPEN 970130. 0000003800: Dr Miguel Mogyoros / Clinical Research Department Midtown 1 / Suite B010 Denver, CO 80205 Contact: Unspecified (303) 764-2270 OPEN 970130. 0000003813: Infectious Disease Specialists 721 North Tejon Colorado Springs, CO 80903 Contact: Unspecified (719) 576-5176 OPEN 970130. 0000003808: Novum Incorporated 2311 M Street NW / Suite 402 Washington, DC 20037 Contact: Mary Reed (202) 466-8049 OPEN 970130. 0000002941: Wilmington Hospital 501 West 14th Street Wilmington, DE 19801 Contact: Arlene Bincsik (302) 428-2538 OPEN 970130. 0000003780: P Andrew Coley 1842 Hickman Road Jacksonville, FL 32216 Contact: Patricia Jackson (904) 725-6300 OPEN 970130. 0000002600: Goodgame Medical Group 340 North Maitland Avenue Maitland, FL 32751 Contact: Chuck DeMarzo (407) 647-3960 OPEN 970130. 0000003797: Dr Anthony LaMarca 4011 North Federal Highway Fort Lauderdale, FL 33308 Contact: Denise LaMarca (954) 564-4222 OPEN 970130. 0000003295: North Broward Hospital District 300 Southeast 17th Street Fort Lauderdale, FL 33316 Contact: Tim Palmer-Pattison (954) 467-3006 Contact: (954) 355-5560 OPEN 970130. 0000003776: Palm Beach Pharmaceuticals Research Center 1897 Palm Beach Lakes Boulevard / Suite 213 West Palm Beach, FL 33409 Contact: Jennifer Burke (407) 698-0606 OPEN 970130. 0000002995: Infectious Disease Research Institute Incorporated 4728 North Habana Avenue / Suite 303 Tampa, FL 33614 Contact: Kalliope Halkias (813) 875-4374 OPEN 970130. 0000003783: McGregor Clinic / Lee County Public Health Unit 2241 McGregor Boulevard Fort Myers, FL 33901 Contact: Janet Busch (941) 334-9555 OPEN 970130. 0000003812: Dr Robert Schwartz 3677 Central Avenue / Suite D Fort Myers, FL 33919 Contact: Debbie Jardine (941) 936-1700 OPEN 970130. 0000003788: Dr Daniel H Gervich 1601 NW 114th Street / Suite 347 Des Moines, IA 50325 Contact: Deb Foshe (515) 224-1777 OPEN 970130. 0000002992: University of Iowa 200 Hawkins Drive / SW54-GH Iowa City, IA 52242 Contact: Julie Katreres (319) 356-3168 OPEN 970130. 0000003806: Dr John Pottage 404 North State Street / 27th Floor Chicago, IL 60610 Contact: Jane Burdgick (312) 494-2330 OPEN 970130. 0000003801: Northwestern University / Division of Infectious Diseases 303 East Superior Street / 8E Passivant Pavillion / Room 828 Chicago, IL 60611 Contact: Unspecified (312) 908-8358 OPEN 970130. 0000003796: Rush Presbyterian / Saint Luke's Medical Center / Infect Dis 600 South Pauling / Suite 143 AcFac Chicago, IL 60612 Contact: Lisa Pitler (312) 942-5865 OPEN 970130. 0000003789: Indiana University Medical School 550 North University Boulevard / Room 5550 Indianapolis, IN 46202 Contact: Beth Zwickl (317) 630-6262 OPEN 970130. 0000003790: University of Kentucky Med Cntr / Dept of Med / Div of ID 800 Rose Street / MN 633 Lexington, KY 40563 Contact: Karen Meekins (606) 323-6327 OPEN 970130. 0000003781: Medical Research Center 1020 Gravier Street / Suite 100 New Orleans, LA 70112 Contact: Unspecified (504) 523-3600 OPEN 970130. 0000002857: New England Medical Center 750 Washington Street / PO Box 67 Boston, MA 02111 Contact: Christine Sullivan (617) 636-7008 OPEN 970130. 0000003793: Beth Israel Hospital / Virology Research Clinic 330 Brookline Avenue / Room 325 Boston, MA 02215 Contact: Shelie Huffey (617) 667-5890 OPEN 970130. 0000003814: New England Deaconess Hospital One Autumn Street AK6 Boston, MA 02215 Contact: Helen Fitch (617) 632-7635 OPEN 970130. 0000003810: International Medicine and Infectious Disease 800 East 28th Street / Abbott Northwestern CL42 Minneapolis, MN 55407 Contact: Joanne Armstrong (612) 824-1772 OPEN 970130. 0000003803: Trinity Lutheran Hospital / HIV Program 3030 Ballerman Kansas City, MO 64108 Contact: Julie Macaulay (816) 752-2925 OPEN 970130. 0000003802: Infectious Disease Associates of Central New Jersey 411 Courtyard Drive Somerville, NJ 08876 Contact: Helen Ferlazzo (908) 725-2552 OPEN 970130. 0000003795: Dr David Kaufman 314 West 14th Street New York, NY 10014 Contact: Pat Costello (212) 620-0144 OPEN 970130. 0000003782: Saint Vincent Medical Center 355 Bard Avenue Staten Island, NY 10310 Contact: Unspecified (718) 876-2300 OPEN 970130. 0000001334: SUNY / Erie County Medical Center at Buffalo 462 Grider Street / Suite 35 Buffalo, NY 14215 Contact: Holly Ingelfinger-Lopez (716) 898-4119 OPEN 970130 ACTU: 1102. 0000003775: Associates in Medical and Mental Health 2325 South Harvard / Suite 600 Tulsa, OK 74114 Contact: Dan Rhodes (918) 743-1000 OPEN 970130. 0000003601: The Research and Education Group 2701 NW Vaughn / Suite 840 Portland, OR 97210-5311 Contact: Norma Martinez (503) 229-8428 OPEN 970130. 0000000966: Novum Incorporated 5900 Penn Avenue Pittsburgh, PA 15206-3817 Contact: Kathy Opel (412) 363-3300 OPEN 970130. 0000003784: Hershey Medical Center / Dept of Med / Div of Hematology 500 University Drive / Room C6606 Hershey, PA 17033 Contact: Fran Damianos (717) 531-8399 OPEN 970130. 0000003785: University of Pennsylvania / Division of Infectious Diseases 536 Johnson Pavillion / 36th Street and Hamilton Walk Philadelphia, PA 19104 Contact: Unspecified (215) 662-2473 OPEN 970130. 0000003799: Omega Medical Research 400 Reservoir Avenue Providence, RI 02987 Contact: Johanna Pezzullo (401) 467-7760 OPEN 970130. 0000003778: Dr Alfred Burnside 14 Calendar Court Columbia, SC 29206 Contact: John Windham (803) 787-1113 OPEN 970130. 0000003779: Medical University of South Carolina / Div of Infect Dis 171 Ashley Avenue / Room 807 CSB Building Charleston, SC 29425 Contact: Carol Reed (803) 792-4542 OPEN 970130. 0000003811: Dr Susie Sargent 956 Court Avenue / Suite H308 Memphis, TN 38163 Contact: Michael Herr (901) 448-5770 OPEN 970130. 0000003786: Dr Walter Gaman 4301 North MacArthur Boulevard / Suite 200 Irving, TX 75038 Contact: Leslie Davis (214) 257-3724 OPEN 970130. 0000003807: Nelson Tebedo Clinic 4012 Cedar Springs Dallas, TX 75219 Contact: Larry Stone (214) 528-2336 OPEN 970130. 0000003804: U of Texas / Southwestern Medical Center at Dallas 5323 Harry Hines Boulevard / Gen Internal Medicine K1 900 Dallas, TX 75235 Contact: Unspecified (214) 648-3880 OPEN 970130. 0000003787: Houston Clinical Research Network / Div of Montrose Clinic 215 Westheimer Houston, TX 77006 Contact: Barbara Burkehart (713) 520-2000 OPEN 970130. 0000003805: University of Texas Medical Branch / Div of Infectious Dis 301 University Boulevard / Route 0835 Galveston, TX 77555 Contact: Unspecified (409) 772-4979 OPEN 970130. 0000003075: Hampton Roads Medical Specialists 2112 Executive Drive Hampton, VA 23666 Contact: Lois Ullman (804) 838-8677 OPEN 970130. 0000003507: Advanced Research Management 600 Broadway Seattle, WA 98122-5314 Contact: Becky Dyer (206) 726-9465 OPEN 970130. *****************************************************************