Date: Fri, 21 Jun 1996 11:56:41 -0400 From: "Flynn Mclean" Subject: New Protocols 06/21/96 (1 of 3) June 14, 1996 1 of 3 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. Descriptions of the 4 most recent clinical trials added to the ACTIS database are 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: NCI 95 C-184. TITLE: Phase I Study of Levamisole in Children and Adolescents With Advanced Human Immunodeficiency Virus Infection. PHASE: Phase I. DISEASE STATUS: Patients have the following symptoms and conditions: Advanced HIV infection. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: Advanced HIV infection. AGE: 02 Years - 21 Years. SEX: M. F. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: Unspecified cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- AGE: 01 Days - 01 Years. 22 Years - 99 Years. GENERIC DRUG NAME ----------------- Drug 1: Levamisole hydrochloride. Immunomodulator. Drug 2: Zidovudine. Antiretroviral. Drug 3: Didanosine. Antiretroviral. DRUG TRADE NAME --------------- Drug 1: Ergamisol. Drug 2: Retrovir. Drug 3: Videx. DRUG COMPANIES -------------- Drug 1: Janssen Research Foundation 1125 Trenton-Harbourton Road Titusville, NJ 08560-0200 Contact: Professional Services Depart (800) 253-3682. Drug 2: Glaxo Wellcome 5 Moore Drive / PO Box 13398 Research Triangle Park, NC 27709 Contact: Department of Consumer Affairs (800) 437-0992 X 7900. Drug 3: Bristol - Myers Squibb Company 2400 West Lloyd Expressway Evansville, IN 47721-0001 Contact: Information (800) 662-7999. PARTICIPATING UNITS ------------------- 0000001821: National Cancer Institute 9000 Rockville Pike / Clinical Center Bethesda, MD 20892 Contact: Susan Sandelli (301) 402-1391 Contact: (301) 402-1387 OPEN / USA accrual 951201. ************************************************************************ PROTOCOL NUMBER: NCI 95 C-192. TITLE: Phase I Protocol for the Administration of 2'-beta-Fluoro-2',3'-Dideoxyadenosine ( F-ddA ) to Patients With HIV-Associated Diseases. PHASE: Phase I. DISEASE STATUS: Patients have the following symptoms and conditions: 1. Symptomatic HIV infection or AIDS. 2. CD4 count 100-400 cells/mm3. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Symptomatic HIV infection or AIDS. 2. CD4 count 100-400 cells/mm3. 3. Ambulatory status. 4. Life expectancy greater than 3 months. AGE: 18 Years - 65 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test. Not breast-feeding. Abstinence or effective method of birth control /contraception during the study and for 60 days after. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 9.0 g/dl. (men); >= 8.8 g/dl (women). PLATELET COUNT: >= 75000 platelets/mm3. CD4 (T4 CELL) COUNT: 100 - 400 cells/mm3. ( 100 - 200 - 300 - 400 ). BILIRUBIN: <= 2 x ULN mg/dl. (ULN = upper limit of normal). SGOT (AST): <= 2 x ULN. CREATININE: <= 1.5 mg/dl. CREATININE CLEARANCE: >= 50 ml/min. /1.73 m2. OTHER LABORATORY VALUES: Absolute neutrophils: >= 1000 cells/mm3. Alkaline phosphatase: <= 2 x ULN. Amylase <= 1.5 x ULN (unless predominantly salivary amylase upon fractionation). Lipase <= 1.5 x ULN. Triglycerides <= 750 mg/dl. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions are excluded: 1. Prior hepatic cirrhosis. 2. Prior cardiomyopathy or other significant cardiac disease. 3. Prior pancreatitis. AGE: 01 Days - 17 Years. 66 Years - 99 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test. Breast-feeding. No abstinence or no agreement to use effective method of birth control during study and for 60 days after. PRIOR MEDICATION: Excluded within the past 3 weeks: Antiretrovirals. Excluded within the past 2 weeks: Acute treatment for a serious infection or for any AIDS-defining opportunistic infection. Excluded within the past 4 weeks: 1. Cytotoxic chemotherapy. 2. Steroids. 3. Interferon. 4. Immunomodulators. 5. Any investigational drugs. CONCURRENT MEDICATION: Excluded: 1. Foscarnet. 2. Ganciclovir. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms and conditions are excluded: 1. Hepatic dysfunction. 2. Evidence of cardiomyopathy or other significant cardiac disease. 3. Grade 2 peripheral neuropathy. 4. Active life-threatening infection (other than HIV). 5. Kaposi's sarcoma or other tumor that is likely to require cytotoxic anti-tumor therapy within the next 6 months. 6. Severe malabsorption. GENERIC DRUG NAME ----------------- Drug 1: 2-Fluoro-2',3'-dideoxyadenosine. Antiviral. DRUG TRADE NAME --------------- Drug 1: F-ddA. DRUG COMPANIES -------------- Drug 1: Drugs are provided by each participating unit site . END POINT --------- MTD or plateau of drug activity. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the followings reasons: 1. Unacceptable toxicity. 2. General debilitation or mental incapacity that would preclude informed consent. PARTICIPATING UNITS ------------------- 0000003536: National Cancer Institute 9000 Rockville Pike / Clinical Center Bethesda, MD 20892 Contact: Jill Lietzau (800) 772-5464 X 607 OPEN / USA accrual 960517. ********************************************************************* PROTOCOL NUMBER: NCI 96 C-4. TITLE: Phase II Study of Oral Thalidomide for Patients With HIV Infection and Kaposi's Sarcoma. PHASE: Phase II. DISEASE STATUS: Patients have the following symptoms and conditions: 1. HIV infection. 2. Extra-pulmonary, non-life-threatening Kaposi's sarcoma that has progressed over the past 2 months. 3. Evaluable disease by noninvasive methods. 4. At least 5 measurable lesions that have never received local therapy. (Actively bleeding or critically located lesions must not pose an immediate risk.) 5. On a stable dose of antiretroviral therapy unless considered not medically indicated. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. Extra-pulmonary, non-life-threatening, progressive, Kaposi's sarcoma. 3. Evaluable disease with at least 5 lesions that have not received local therapy. 4. Stable antiretroviral therapy unless considered not medically indicated. 5. Life expectancy greater than 3 months. AGE: 18 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test. Abstinence or agree to use both barrier and hormonal methods of birth control / contraception until 4 weeks after study. PRIOR MEDICATION: Required (unless not medically indicated): stable dose of antiretroviral therapy for the past 2 weeks. CONCURRENT MEDICATION: Required (unless not medically indicated): stable dose of antiretroviral therapy. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 8.0 g/dl. (or transfusion within past month). PLATELET COUNT: >= 70000 platelets/mm3. CD4 (T4 CELL) COUNT: Unspecified cells/mm3. BILIRUBIN: <= 2.0 mg/dl. SGOT (AST): <= 125 units/l. CREATININE: <= 1.5 mg/dl. CREATININE CLEARANCE: >= 70 ml/min. /1.73 m2. OTHER LABORATORY VALUES: Absolute neutrophils: > 750 cells/mm3. APTT or PT: <= 120 percent of control. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions are excluded: 1. History of hepatic cirrhosis. 2. History of tumors or malignancies other than KS, except for malignancies that have been in complete remission for at least 1 year or completely resected basal cell carcinoma of the skin. 3. Underlying severe or life-threatening infection within the past 2 weeks. 4. Fever (39 C or greater) within the past 10 days unless not caused by a severe, underlying infection. AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test. No abstinence or no agreement to use both barrier and hormonal methods of birth control / contraception. RISK BEHAVIOR: Unwilling to refrain from unprotected sexual contact or other activities that may cause re-infection with HIV. Unwilling to refrain from sedating recreational drugs or alcohol. PRIOR TREATMENT: Excluded within past month: 1. Radiation therapy. 2. Intralesional injections or other local treatment modalities. PRIOR MEDICATION: Excluded within the past 6 months: suramin. Excluded since the onset of KS: thalidomide. Excluded within the past month: 1. Cytotoxic chemotherapeutic agents. 2. Interferon. 3. Other systemic anti-KS agents or regimens. 4. Systemic steroids (except for physiologic replacment doses of corticosteroids). CONCURRENT MEDICATION: Excluded: 1. Other specific KS therapy during the first 6 months of study. 2. Drugs with sedating activity, unless taken in minimal doses. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: 1. Grade 2 or worse peripheral neuropathy, except for localized neuropathy due to a mechanical cause or trauma. 2. Current tumors or malignancies other than KS. 3. Grade 3 or worse toxicity other than lymphopenia or neutropenia. 4. Known hypersensitivity to thalidomide or related compounds. GENERIC DRUG NAME ----------------- Drug 1: Thalidomide. Immunomodulator. DRUG COMPANIES -------------- Drug 1: Drugs are provided by each participating unit site . DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Number of lesions doubles. 2. New or progressive visceral disease requiring standard therapy. 3. Tumor-associated edema or effusions that appear or worsen and require standard therapy. 4. Other changes in condition that preclude further thalidomide therapy. 5. Irreversible grade 3 or any grade 4 nonhematologic toxicity, unless deemed unrelated to thalidomide. 6. Pregnancy or lack of willingness to use recommended contraception. PARTICIPATING UNITS ------------------- 0000003539: National Cancer Institute 9000 Rockville Pike / Clinical Center Bethesda, MD 20892 Contact: Kathy Wyvill (800) 772-5464 X 507 OPEN / USA accrual 960213. ************************************************************************ PROTOCOL NUMBER: NIAID 96 HG-51. TITLE: Gene Therapy for AIDS Using Retroviral Mediated Gene Transfer to Deliver HIV-1 Antisense TAR and Transdominant Rev Protein Genes to Syngeneic Lymphocytes in HIV-1 Infected Identical Twins. PHASE: Phase I / Phase II. DISEASE STATUS: Patients have the following symptoms and conditions: 1. HIV seropositive, with a healthy, HIV seronegative identical twin. 2. CD4 count > 50 cells/mm3 in the HIV-infected patient. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV seropositivity. 2. CD4 count > 50 cells/mm3. 3. A healthy, HIV seronegative identical twin donor who is available for apheresis throughout the study. AGE: 18 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: > 50 cells/mm3. ( 100 - 200 - 300 - 400 - 500 - 600 - 700 - 800 - plus ). PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior condition are excluded: History of lymphoma. AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Pregnant. CONCURRENT MEDICATION: Excluded in recipient twin: Systemic KS therapy. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: Acute or acutely progressing disease processes. Donor twins with the following symptoms or conditions are excluded: 1. Unstable medical condition that would preclude apheresis. 2. Seropositive for CMV or EBV, if recipient is negative for these. 3. Positive for active or suspected hepatitis B or C. GENERIC DRUG NAME ----------------- Drug 1: Lymphocytes, Activated. Immunomodulator. DRUG COMPANIES -------------- Drug 1: Drugs are provided by each participating unit site. PARTICIPATING UNITS ------------------- 0000003153: National Institute of Allergy & Infectious Diseases 9000 Rockville Pike / Clinical Center / Room 11C304 Bethesda, MD 20892 Contact: Unspecified (800) 243-7644 OPEN / USA accrual 960412. ************************************************************************* Date: Fri, 21 Jun 1996 14:48:10 -0400 From: "Flynn Mclean" Subject: New Protocol Records 06/21/96 (2 of 3) New Protocol Records 06/21/96 Part 2 of 3 ***************************************************************** PROTOCOL NUMBER: NIAID ACTG 273. TITLE: A Phase I/II Study of HIVIG in Slowing Progression of Disease in HIV-Infected Children. PHASE: Phase I / Phase II. DISEASE STATUS: Patients have the following symptoms and conditions: 1. HIV infection. 2. CD4 count > 200 cells/mm3 (ages 2-5 years) or > 100 cells/mm3 (age > 5 years). 3. Antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry. 4. Plasma ICD p24 >= 70 pg/ml that is stable or increasing prior to study entry. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. CD4 count > 200 cells/mm3 (ages 2-5 years) or > 100 cells/mm3 (age > 5 years). 3. Antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry. 4. Plasma ICD p24 >= 70 pg/ml that is stable or increasing prior to study entry. 5. Life expectancy of at least 6 months. AGE: 02 Years - 12 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. WEIGHT: < 45 kg. PRIOR MEDICATION: Required: Antiretroviral therapy for at least 6 months, with stable dose for at least 3 months. CONCURRENT MEDICATION: Required: PCP prophylaxis according to CDC guidelines. Allowed: 1. Varicella-zoster immunoglobulin. 2. Hepatitis B immunoglobulin. 3. Prophylactic therapies not involving immunoglobulin. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: > 200 cells/mm3. (if ages two-five years) and > 100 cells/mm3 (if > five years). ( 100 - 200 - 300 - 400 - 500 - 600 - 700 - 800 - plus ). PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior condition are excluded: History of severe reaction to IVIG. AGE: 01 Days - 01 Years. 13 Years - 99 Years. REPRODUCTIVE SPECIFICATION: Pregnant. WEIGHT: >= 45 g. RISK BEHAVIOR: Ongoing drug or alcohol abuse. PRIOR MEDICATION: Excluded: 1. IVIG within the past 60 days. 2. Chemotherapy for an active malignancy within the past year. 3. MMR or rubella vaccinations within the past 6 months. 4. Intramuscular immunoglobulin within the past 60 days. CONCURRENT MEDICATION: Excluded: 1. IVIG. 2. Chemotherapy for an active malignancy. 3. MMR or rubella vaccinations. 4. Intramuscular immunoglobulin. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: 1. Severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of IVIG. 2. Any other condition requiring dosing with IVIG (e.g., ITP, hypogammaglobulinemia). 3. Acute illness with temperature >= 100 F and/or with IV antibiotics. 4. Grade 3 or worse clinical toxicities. 5. Unable to tolerate IV infusions at a minimum rate of 0.02 ml/kg/min. 6. Concomitant participation in an experimental antiretroviral or HIV vaccine trial. GENERIC DRUG NAME ----------------- Drug 1: Anti-HIV immune serum globulin (Human). Immunomodulator. DRUG TRADE NAME --------------- Drug 1: HIVIG. DRUG COMPANIES -------------- Drug 1: North American Biologicals Incorporated 16500 Northwest 15th Avenue Miami, FL 33169 Contact: Dr Christine Sapan (305) 625-5303. END POINT --------- Toxicity, pharmacokinetic profile, efficacy. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Unacceptable toxicity, including severe allergic reaction. 2. Clinical deterioration that requires change in antiretroviral regimen. 3. Inadequate compliance. 4. At request of parent or guardian, investigator, FDA, pharamaceutical sponsor, or NIAID Division of AIDS. PARTICIPATING UNITS ------------------- 0000001402: UCLA Medical Center / Pediatric 10833 Le Conte Avenue / 22-404 MDCC Los Angeles, CA 90095-1752 Contact: Leslie Spring (310) 206-6369 OPEN 960501 ACTU: 3601. 0000001410: Long Beach Memorial / UCLA Medical Center 10833 Le Conte Avenue / 22-404 MDCC Los Angeles, CA 90095-1752 Contact: Leslie Spring (310) 206-6369 OPEN 960501 ACTU: 3606. 0000001287: Moffitt Hospital / UCSF 505 Parnassus Avenue / Box 0105 / M-601 San Francisco, CA 94143-0105 Contact: Debbie Trevithick (415) 476-6480 OPEN 960528 ACTU: 4501. 0000001395: Children's Hospital of Oakland 747 52nd Street Oakland, CA 94609-1809 Contact: Teresa Courville (510) 728-3885 X 2827 OPEN 960607 ACTU: 4504. 0000002205: Children's Hosp of Washington DC / Children's Natl Med Ctr 111 Michigan Avenue NW / Suite 6112 Washington, DC 20010-2970 Contact: Sandra Jones (202) 884-3682 OPEN 960612 ACTU: 7101. 0000003235: University of Florida Health Science Center / Pediatrics 653-1 West 8th Street Jacksonville, FL 32209 Contact: Michelle Eagle (904) 549-3051 OPEN 960501 ACTU: 5051. 0000001368: University of Miami School of Medicine / Pediatrics 1800 Northwest 10th Avenue / D-91 Miami, FL 33136 Contact: Brenda Haliburton-Jones (305) 548-4445 OPEN 960502 ACTU: 4201. 0000002298: Baystate Medical Center of Springfield 759 Chestnut Street / SHU-Main 3 Springfield, MA 01199 Contact: Mari Pat Toye (413) 784-5399 OPEN 960516 ACTU: 7302. 0000002379: University of Massachusetts Medical Center 55 Lake Avenue North Worcester, MA 01655-0001 Contact: Joanne Shepard (508) 856-1692 OPEN 960516 ACTU: 7301. 0000001352: Children's Hospital of Boston 300 Longwood Avenue / Carnegie Building / Third Floor Boston, MA 02115 Contact: Robert Bishop (617) 355-8198 OPEN 960502 ACTU: 2901. 0000001353: Boston City Hospital / Pediatrics 774 Albany Street / Finland Lab / Room 301 Boston, MA 02118 Contact: Anne Marie Regan (617) 534-5813 OPEN 960529 ACTU: 2903. 0000001274: Children's Hospital of Michigan 3901 Beaubien Boulevard Detroit, MI 48201 Contact: Charnell Cromer (313) 745-7857 OPEN 960607 ACTU: 5041. 0000001333: Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl 15 South 9th Street Newark, NJ 07107-2198 Contact: Dr Deborah Storm (201) 982-5066 OPEN 960514 ACTU: 2801. 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. 0000001276: Harlem Hospital Center 506 Lenox Avenue / Room 16-119 New York, NY 10037 Contact: Delia Calo (212) 939-4045 Contact: (212) 939-4043 OPEN 960501 ACTU: 5006. 0000001279: North Shore University Hospital 865 Northern Boulevard / Suite 104 Great Neck, NY 11021 Contact: Emily Cupelli (516) 773-7676 OPEN 960509 ACTU: 5010. 0000001277: SUNY / Health Sciences Center at Brooklyn 450 Clarkson Avenue / Box 49 Brooklyn, NY 11203 Contact: Savina Wiltshire (718) 270-3185 OPEN 960501 ACTU: 5008. 0000001423: Children's Hospital at Albany Medical Center 47 New Scotland Avenue / A-111 Albany, NY 12208 Contact: Mary Ellen Adams (518) 262-6888 OPEN 960501 ACTU: 5042. 0000003520: University of Rochester Medical Center Box 689 / 601 Elmwood Avenue Rochester, NY 14642 Contact: Barbara Murante (716) 275-5871 Contact: (716) 275-1549 OPEN 960520 ACTU: 1106. 0000001308: Columbus Children's Hospital 700 Children's Drive Columbus, OH 43205-2696 Contact: Jane Hunkler (614) 722-4460 OPEN 960606 ACTU: 2302. 0000001415: Children's Hospital of Philadelphia 34th Street & Civic Center Boulevard Philadelphia, PA 19104-4399 Contact: Deborah Schaible (215) 596-9138 OPEN 960607 ACTU: 6701. 0000002199: Medical University of South Carolina 171 Ashley Avenue / 312 Clinical Science Building Charleston, SC 29425-3312 Contact: Nadine Chavin (803) 792-2385 X 2123 OPEN 960606 ACTU: 5037. 0000002356: Vanderbilt School of Medicine A3310 Medical Center North Nashville, TN 37232 Contact: Sandi Alls (615) 936-1245 OPEN 960507. 0000001270: Saint Jude Children's Research Hospital of Memphis 332 North Lauderdale Memphis, TN 38105-2794 Contact: Micki Roy (901) 495-3485 OPEN 960523 ACTU: 6501. 0000001420: Children's Medical Center of Dallas 1935 Motor Street Dallas, TX 75235 Contact: Diane Ross (214) 640-6198 OPEN 960516 ACTU: 5043. 0000001291: Texas Children's Hospital / Baylor University 6621 Fannin Street / MC1-3291 Houston, TX 77030 Contact: Nancy Calles (713) 770-1319 OPEN 960514 ACTU: 3801.