Date: Wed, 10 Jul 1996 13:29:38 -0400 From: "Flynn Mclean" Subject: New Clinical Trials Information 07/10/96 July 10, 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 ACTG 265. TITLE: Phast I/II Study of Safety and Immunogenicity of Live-Attenuated Varicella Vaccine (Varivax) in HIV-Infected Children. PHASE: Phase I / Phase II. DISEASE STATUS: Patients have the following symptoms and conditions: 1. ALL PATIENTS: Perinatally-acquired HIV infection that is asymptomatic or mildly symptomatic (category N1 or A1). 2. TREATMENT GROUP ONLY: No history of varicella ( chickenpox ) or herpes zoster ( shingles ) and no exposure to chickenpox or shingles within the past 4 weeks. 3. CONTROL GROUP ONLY: Clinically confirmed diagnosis of varicella infection within the past 12 months. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. ALL PATIENTS: Perinatally-acquired HIV infection that is asymptomatic or mildly symptomatic (category N1 or A1). 2. TREATMENT GROUP ONLY: No history of varicella ( chickenpox ) or herpes zoster ( shingles ) and no exposure to chickenpox or shingles within the past 4 weeks. 3. CONTROL GROUP ONLY: Clinically confirmed diagnosis of varicella infection within the past 12 months. AGE: 12 Months - 04 Years. SEX: M. F. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: > 8.9 g/dl. (if < two years of age); > 9.9 g/dl (if >= two years of age). (TREATMENT GROUP). PLATELET COUNT: > 75000 platelets/mm3. (TREATMENT GROUP). CD4 (T4 CELL) COUNT: Unspecified cells/mm3. BILIRUBIN: < 2 x ULN mg/dl. (ULN = upper limit of normal). (TREATMENT GROUP). SGPT (ALT): < 5 x ULN. (TREATMENT GROUP). CREATININE: < 0.9. (if age twelve to twenty-four months); < 1.1 mg/dl (if age twenty-four to forty-eight months). (TREATMENT GROUP). OTHER LABORATORY VALUES: Absolute neutrophils > 750 cells/mm3. (TREATMENT GROUP). PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: TREATMENT GROUP patients with the following prior conditions are excluded: 1. Active intercurrent infection within the past 72 hours. 2. Fever > 101 F within the past 72 hours. AGE: 01 Days - 11 Months. 05 Years - 99 Years. PRIOR TREATMENT: Excluded: Blood products within the past 5 months (or within 5 months prior to a primary varicella episode in Control Group subjects). PRIOR MEDICATION: Excluded in TREATMENT GROUP: 1. VZIG or IVIG within the past 5 months. 2. Another live vaccine within the past month. 3. Inactivated vaccine within the past 2 weeks. 4. Systemic steroids within the past month. 5. Anti-herpes antiviral drug (such as acyclovir, ganciclovir, interferon, foscarnet) within the past week. Excluded in CONTROL GROUP: VZIG or IVIG within 5 months prior to study entry or a primary episode of varicella. CONCURRENT MEDICATION: Excluded in TREATMENT GROUP: 1. Immunosuppressive therapy. 2. Aspirin. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: ALL PATIENTS - 1. Other known or suspected immune disease or TB. 2. Known hypersensitivity to vaccine components, including neomycin. 3. Other chronic medical or surgical condition or contraindication that would interfere with evaluation. TREATMENT GROUP ONLY - Have HIV-infected, indeterminate, or other immunocompromised household members who have no known history of varicella infection. GENERIC DRUG NAME ----------------- Drug 1: Varicella Virus Vaccine Live. Vaccine. DRUG TRADE NAME --------------- Drug 1: Varivax. DRUG COMPANIES -------------- Drug 1: Merck Research Laboratories 126 East Lincoln Avenue Rahway, NJ 07065 Contact: Unspecified (800) 379-1332 Contact: Dr Paul Deutsch (908) 594-5833. END POINT --------- Drug safety, immunogenicity. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Unacceptable toxicity. 2. Immunologic decline, e.g., progression to clinical category B or C or a decrease in CD4+ count of > 50 percent in patients whose CD4+ prior to immunization was > 2000 cells/mm3. PARTICIPATING UNITS ------------------- 0000002201: Children's Hospital of Denver 1056 East 19th Avenue / B-055 Denver, CO 80218-1088 Contact: Carol Salbenblatt (303) 861-6751 OPEN 960415 ACTU: 7001. 0000001363: Chicago Children's Memorial Hospital 2300 Children's Plaza / PO Box 20 Chicago, IL 60614-3394 Contact: Debbie Fonken (312) 880-3669 OPEN 960429 ACTU: 4001. 0000001359: University of Maryland at Baltimore / Univ Medical Center 120 Penn Street Baltimore, MD 21201 Contact: Sue Lovelace (410) 706-8220 OPEN 960603 ACTU: 3702. 0000001358: Johns Hopkins University Hospital 600 North Wolfe Street / Blalock 1140 Baltimore, MD 21287 Contact: Laura J Flautt (410) 955-9749 OPEN 960424 ACTU: 3701. 0000001341: Duke University Medical Center PO Box 3499 Durham, NC 27710 Contact: John Swetnam (919) 684-6335 OPEN 960510 ACTU: 4701. 0000001311: Bellevue Hospital / New York University Medical Center 550 First Avenue New York, NY 10016 Contact: Nagamah S Deygoo (212) 263-6426 OPEN 960606 ACTU: 4401. 0000001321: Columbia Presbyterian Medical Center 622 West 168th Street New York, NY 10032 Contact: Babette Tang (212) 305-7222 OPEN 960509 ACTU: 4101. 0000001458: Incarnation Children's Ctr / Columbia Presbyterian Med Ctr 622 West 168th Street New York, NY 10032 Contact: Babette Tang (212) 305-7222 OPEN 960509 ACTU: 4103. 0000001416: SUNY / Health Sciences Center at Stony Brook / Pediatrics HSC-T15 / Room 080 Stony Brook, NY 11794-8111 Contact: Michel Davi (516) 444-7809 OPEN 960515 ACTU: 5040. *******************************************************************