Date: Wed, 6 Mar 1996 12:26:19 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: New Information from ACTIS 03/06/96 March 6, 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: NIAID VEU 026. TITLE: A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers. PHASE: Phase I. DISEASE STATUS: Volunteers have the following conditions: 1. Normal history and physical exam. 2. Negative for HIV by ELISA and Western blot within 8 weeks prior to study entry. 3. Absolute CD4 count >=400 cells/mm3. 4. Normal urine dipstick with esterase and nitrite. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Volunteers must have: 1. Normal history and physical exam. 2. ELISA and Western blot negative for HIV. 3. CD4 count >= 400 cells/mm3. 4. Normal urine dipstick with esterase and nitrite. 5. Lower risk sexual behavior. AGE: 18 Years - 60 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test. Not breast-feeding. Abstinence or effective method of birth control/contraception including oral contraceptives during the study. LABORATORY VALUES AT ENTRY -------------------------- HEMATOCRIT: >= 34 percent. (women); >= 38 percent (men). PLATELET COUNT: 150000 - 550000 platelets/mm3. CD4 (T4 CELL) COUNT: >= 400 cells/mm3. (400 - 500 - 600 - 700 -800 - plus). SGPT (ALT): <= 1.5 x ULN. (ULN = upper limit of normal). CREATININE: <= 1.6 mg/dl. OTHER LABORATORY VALUES: WBC >= 3500 cells/mm3 with normal differential. Total lymphocytes >= 800 cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Subjects with the following prior conditions are excluded: 1. History of immunodeficiency, chronic illness, automimmune disease, or use of immunosuppressive medications. 2. History of anaphylaxis or other serious adverse reactions to vaccines. 3. Prior immunization against rabies. 4. History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Steven-Johnson syndrome, bronchospasm, or hypotension). 5. Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance. 6. History of cancer unless there has been surgical excision that is considered to have achieved cure. AGE: 01 Days - 17 Years. 61 Years - 99 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test. Breast-feeding. No abstinence or no agreement to use effective method of birth control/contraception during the study. RISK BEHAVIOR: Identifiable high-risk behavior for HIV infection, such as - injection drug use within past 12 months. - higher or intermediate risk sexual behavior. PRIOR TREATMENT: Excluded: Blood products or immunoglobulin within 6 months prior to study entry. PRIOR MEDICATION: Excluded: 1. Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations. 2. Experimental agents within 30 days prior to study entry. 3. Prior HIV vaccines. 4. Prior rabies immunization. CO-EXISTING CONDITIONS OR DISEASES: Subjects with the following symptoms or conditions are excluded: 1. Positive hepatitis B surface antigen. 2. Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance. 3. Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible. 4. Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible. 5. Allergy to egg products or neomycin. AVAILABILITY: Unavailable for 24 months of follow-up. GENERIC DRUG NAME ----------------- Drug 1: rgp120/HIV-1SF2. Vaccine. Drug 2: ALVAC-HIV MN120TMGNP ( vCP300 ). Vaccine. Drug 3: ALVAC-RG rabies glycoprotein ( vCP65 ). Vaccine. DRUG COMPANIES -------------- Drug 1: BIOCINE Company 4560 Horton Street Emeryville, CA 94608-2916 Contact: Dr Anne-Marie Duliege (510) 601-2715. Drug 2: Pasteur Merieux Serums et Vaccins 3 Avenue Pasteur / BP 10 Marnes la Coquette, FR 92430 Contact: Dr Jean-Louis Excler 011-33-147-417-922. Drug 3: Pasteur Merieux Serums et Vaccins 3 Avenue Pasteur / BP 10 Marnes la Coquette, FR 92430 Contact: Dr Jean-Louis Excler 011-33-147-417-922. PARTICIPATING UNITS ------------------- 0000003328: University of Alabama at Birmingham 908 20th Street South / CCB 178 / AVEU Clinic Birmingham, AL 35294-2050 Contact: James Raper (205) 975-2840 OPEN 960131 ACTU: 6009. 0000001429: St Louis University School of Medicine 1402 South Grand Boulevard St Louis, MO 63104 Contact: Dr Robert B Belshe (314) 577-8648 OPEN 960216 ACTU: 6007. 0000001453: University of Rochester Medical Center 601 Elmwood Avenue / Box 689 Rochester, NY 14642 Contact: Shirley Erb (716) 275-5871 OPEN 960131 ACTU: 6005. 0000002222: Vanderbilt University Hospital 21st & Garland Avenue / Medical Center North / Room C3210 Nashville, TN 37232 Contact: Lois Wagner (615) 343-6260 OPEN 960122 ACTU: 6006. 0000002195: University of Washington / Pacific Medical Center 1200 12th Avenue South / Room 9301 Seattle, WA 98144 Contact: David Berger (206) 621-4179 OPEN 960220 ACTU: 6008. *****************************************************************