Date: Mon, 15 Jul 1996 18:56:23 -0400 From: "Martha Vander Kolk" Subject: New Information from ACTIS 07/15/96 ----------------------- Message requiring your approval ---------------------- Sender: "Flynn Mclean" Subject: New Information from ACTIS 07/15/96 July 15, 1996 NEW INFORMATION FROM ACTIS The AIDS Clinical Trials Information Service (ACTIS) is acentral 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 ACTG 293. TITLE: A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Cervical Dysplasia in HIV-Infected Women. PHASE: Phase III. DISEASE STATUS: Patients have the following symptoms and conditions: 1. Documented HIV infection. 2. Biopsy-proven grade I CIN (low grade cervical dysplasia). Biopsy must be made within the past 12 weeks. NOTE: Current grade II or III CIN or invasive cancer is NOT eligible. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. Grade I CIN. 3. Consent of parent or guardian if less than 18 years old. AGE: 13 Years - 99 Years. SEX: F. REPRODUCTIVE SPECIFICATION: Not pregnant. Negative pregnancy test within 7 days of study entry. Abstinence or agree to use both barrier and hormonal methods of birth control / contraception. CONCURRENT MEDICATION: Allowed: 1. Approved antiretrovirals. 2. Prophylaxis for opportunistic infections. 3. Contraceptives. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: Unspecified cells/mm3. SGOT (AST): <= 5 x ULN. (ULN = upper limit of normal). SGPT (ALT): <= 5 x ULN. KARNOFSKY: >= 70. OTHER LABORATORY VALUES: Triglycerides <= 750 mg/dl. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions are excluded: 1. Malignancy requiring cytotoxic chemotherapy within the past 3 months. 2. Hysterectomy within the past 4 months. AGE: 01 Days - 12 Years. SEX: M. REPRODUCTIVE SPECIFICATION: Pregnant. Positive pregnancy test within 7 days of study entry. No abstinence or no agreement to use both barrier and hormonal methods of birth control / contraception. PRIOR MEDICATION: Excluded: 1. Prior treatment for grade II or III CIN. 2. Cytotoxic chemotherapy within the past 3 months. 3. Ablative therapy within the past 4 months. 4. Retinoid therapy within the past 3 months. 5. Topical medications within the past month. CONCURRENT MEDICATION: Excluded: 1. Tetracycline. 2. Vitamin A. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms or conditions are excluded: 1. Dysplasia in endocervical curettage specimen. 2. Pap smear more severe by two or more grades than the colposcopically directed biopsy. 3. Unsatisfactory colposcopy. 4. Known allergic reaction to any retinoid. GENERIC DRUG NAME ----------------- Drug 1: Isotretinoin. Keratolytic. DRUG TRADE NAME --------------- Drug 1: Accutane. DRUG COMPANIES -------------- Drug 1: Hoffmann - La Roche Incorporated 340 Kingsland Street Nutley, NJ 07110-1199 Contact: Professional Services (800) 526-6367. END POINT --------- Primary: Progression of dysplasia. Secondary: Regression of dysplasia for at least 6 months, toxicity. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Progression to grade II or III CIN or invasive cancer. 2. Unacceptable toxicity. 3. Pregnancy. 4. Study noncompliance or refusal of further treatment. 5. Further participation deemed detrimental to well-being. 6. Requirement for prohibited medication. PARTICIPATING UNITS ------------------- 0000002264: Los Angeles County - USC Medical Center 1929 Zonal Avenue / Health Science Campus (CAB-HSC) Los Angeles, CA 90033 Contact: Lynn Fukushima (213) 226-5068 OPEN 960621 ACTU: 5048. 0000001400: Los Angeles County - USC Medical Center 2020 Zonal Avenue / Room 309 Los Angeles, CA 90033-1079 Contact: Luis Mendez (213) 343-8288 OPEN 960613 ACTU: 1201. 0000001367: University of Miami School of Medicine 1800 Northwest 10th Avenue / P O Box 016960 Miami, FL 33136-1013 Contact: Lisa Rolfe (305) 243-3838 OPEN 960510 ACTU: 0901. 0000001463: University of Hawaii / Leahi Hospital 3675 Kilauea Avenue / Young Building / 6th Floor Honolulu, HI 96816 Contact: Debra M Ogata-Arakaki (808) 737-2751 OPEN 960515 ACTU: 5201. 0000001365: Northwestern University Medical School 303 East Superior Street / Passavant Pavilion / Room 823 Chicago, IL 60611 Contact: Baiba L Berzins (312) 908-4655 Contact: (312) 908-9636 OPEN 960514 ACTU: 2701. 0000001366: Rush Presbyterian - Saint Luke's Medical Center 600 South Paulina Street / Suite 143 Chicago, IL 60612 Contact: Lisa Pitler (312) 942-4810 OPEN 960501 ACTU: 2702. 0000001346: Charity Hospital / Tulane University Medical School 1430 Tulane Avenue New Orleans, LA 70112-2699 Contact: Russell Strada (504) 584-3605 Contact: (504) 584-1692 OPEN 960703 ACTU: 1702. 0000002193: Charity Hospital / Tulane University Medical School 1430 Tulane Avenue / ACTU SL-37 New Orleans, LA 70112-2699 Contact: Jane Price (504) 585-7153 OPEN 960403 ACTU: 7201. 0000001335: Washington University School of Medicine 4511 Forest Park / Suite 304 St Louis, MO 63108 Contact: Michael Klebert (314) 454-0538 Contact: (314) 454-0058 OPEN 960412 ACTU: 2101. 0000001317: Beth Israel Medical Center / Mount Sinai Medical Center First Avenue at 16th Street / Dazian Pavilion / 10th Floor New York, NY 10003 Contact: Ann Marshak (212) 420-4432 OPEN 960418 ACTU: 1802. 0000002263: Saint Clare's Hospital and Health Center 415 West 51st Street New York, NY 10019 Contact: Phyllis Ristau (212) 459-8449 OPEN 960327 ACTU: 2204. 0000001312: Memorial Sloan - Kettering Cancer Center 1275 York Avenue / PO Box 9 New York, NY 10021 Contact: Gloria Gilbert (212) 639-7169 OPEN 960612 ACTU: 2202. 0000001428: SUNY / Health Sciences Center at Syracuse / Pediatrics 750 East Adams Street Syracuse, NY 13210 Contact: Kathie Contello (315) 464-7592 Contact: (315) 464-6331 OPEN 960520 ACTU: 5039. 0000001310: University of Rochester Medical Center 601 Elmwood Avenue / Box 689 Rochester, NY 14642 Contact: Carol Greisberger (716) 275-2740 OPEN 960529 ACTU: 1101. 0000001308: Columbus Children's Hospital 700 Children's Drive Columbus, OH 43205-2696 Contact: Jane Hunkler (614) 722-4460 OPEN 960405 ACTU: 2302. 0000001307: Ohio State University Hospital 456 West 10th Avenue / Room 4725 Columbus, OH 43210-1228 Contact: Judy Neidig (614) 293-8112 Contact: (614) 293-5282 OPEN 960417 ACTU: 2301. 0000001289: San Juan City Hospital / Centro Medico Mail Station 128 / GPO Box 70344 San Juan, PR 00936-7344 Contact: Moraima Rivera (809) 764-3083 OPEN 960327 ACTU: 5031. 0000001272: Children's Hospital and Medical Center of Seattle 4800 Sand Point Way NE Seattle, WA 98105-0371 Contact: Kathleen Mohan (206) 526-2117 OPEN 960612 ACTU: 6801. ****************************************************************** PROTOCOL NUMBER: NIAID CMV STUDY. TITLE: Evaluation of Asymptomatic Cytomegalovirus ( CMV ) Viremia and Response to Oral Ganciclovir. (NOTE: Ganciclovir was discontinued in this study.) DISEASE STATUS: Patients have the following symptoms and conditions: 1. HIV antibody positive. 2. CD4 count < 100 cells/mm3. 3. CMV viremia but no active CMV disease. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. CD4 count < 100 cells/mm3. 3. CMV viremia without active CMV disease. AGE: 18 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Abstinence or agree to use barrier methods of birth control / contraception during the study. CONCURRENT MEDICATION: Allowed: Medication for HIV or opportunistic infections provided dose is stable. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: > 8.5 g/dl. PLATELET COUNT: > 25000 platelets/mm3. CD4 (T4 CELL) COUNT: < 100 cells/mm3. ( 0 ). SGPT (ALT): < 5 x ULN. (ULN = upper limit of normal). CREATININE CLEARANCE: > 50 ml/min. OTHER LABORATORY VALUES: Absolute neutrophils > 500 cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Pregnant. No abstinence or no agreement to use barrier methods of birth control / contraception during the study. PRIOR MEDICATION: Excluded within the past 3 months: 1. Ganciclovir. 2. Foscarnet. 3. Cidofovir ( HPMPC ). 4. Other investigational CMV drugs. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms and conditions are excluded: 1. Hypersensitivity to ganciclovir. 2. Gastrointestinal problems that would interfere with absorption of ganciclovir. AVAILABILITY: Unavailable for frequent clinic visits. GENERIC DRUG NAME ----------------- Drug 1: Ganciclovir. Antiviral. DRUG COMPANIES -------------- Drug 1: Roche Global Development - Palo Alto 3401 Hill View Avenue Palo Alto, CA 94303 Contact: Roche - Syntex Information (800) 444-4200. 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 960424. ******************************************************************* PROTOCOL NUMBER: NIAID DATRI 013. TITLE: A Phase I Study of Methotrexate for HIV Infection. PHASE: Phase I. DISEASE STATUS: Patients have the following symptoms and conditions: 1. Early HIV infection. 2. CD4 count >= 300 cells/mm3 within the past 30 days. 3. No AIDS-defining condition. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV seropositivity. 2. CD4 count >= 300 cells/mm3. 3. No AIDS-defining condition. AGE: 18 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not pregnant. Not breast-feeding. Abstinence or agree to use barrier methods of birth control / contraception during the study. CONCURRENT MEDICATION: Allowed: 1. Antiemetics and antidiarrheals. 2. Acetaminophen. 3. Oral hypoglycemic agents. 4. Stable dose of antiretroviral (must be stable for at least 1 month prior to study entry). LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 10.0 g/dl. (women); >= 11.0 (men). PLATELET COUNT: >= 150000 platelets/mm3. CD4 (T4 CELL) COUNT: >= 300 cells/mm3. ( 300 - 400 - 500 - 600 - 700 - 800 - plus ). BILIRUBIN: <= 1.5 x ULN mg/dl. (ULN = upper limit of normal). SGOT (AST): <= 2.5 x ULN. SGPT (ALT): <= 2.5 x ULN. CREATININE: <= 1.5 mg/dl. KARNOFSKY: >= 80. OTHER LABORATORY VALUES: Absolute neutrophils > 1500 cells/mm3. Alkaline phosphatase <= 2.5 x ULN. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with the following prior conditions are excluded: 1. Prior malignancies. 2. Prior mucocutaneous herpes infection requiring antiviral therapy. 3. Anergic on DTH skin test within the past month (patients who are positive on DTH skin test but unable to receive the HIV-1 skin test because of allergies to insects, bee stings, etc., remain eligible for study enrollment). 4. Inflammatory bowel disease, peptic ulcer disease, obesity combined with insulin-requiring diabetes, liver disease, or chronic renal disease within the past 6 months. 5. Positive for HBsAg or hepatitis C antibody within the past 2 weeks. 6. Chest radiograph within the past 60 days that shows cavity disease, infiltrates, or scars from prior disease that would preclude diagnosis of a new infectious process or drug-induced pneumonitis. AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Pregnant. Breast-feeding. No abstinence or no agreement to use barrier methods of birth control / contraception during the study. RISK BEHAVIOR: Alcohol abuse. PRIOR TREATMENT: Excluded: Prior radiotherapy for malignancy. PRIOR MEDICATION: Excluded: Prior chemotherapy for malignancy. CONCURRENT MEDICATION: Excluded: 1. Immunosuppressive or immunomodulatory drugs. 2. Chronic nonsteroidal anti-inflammatory agents. 3. Newly initiated antiretrovirals. 4. Bone marrow suppressive drugs (e.g., TMP/SMX). CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptom or condition are excluded: Current positive PPD. GENERIC DRUG NAME ----------------- Drug 1: Methotrexate. Anti-inflammatory. DRUG COMPANIES -------------- Drug 1: Roxane Laboratories Incorporated 1809 Wilson Road / PO Box 16532 Columbus, OH 43216 Contact: Clinical and Medical Info (800) 327-4865 Contact: Patient Assistance (800) 274-8651 Contact: Information (800) 868-0120. END POINT --------- Drug safety, immunologic markers. DISCONTINUE TREATMENT --------------------- Patients discontinue treatment for the following reasons: 1. Decrease in CD4 count by 50 percent compared to baseline. 2. Unable to tolerate medication for 2 consecutive weeks. 3. Missed more than two doses of methotrexate during the study, or other protocol violation. 4. Occurrence of adverse events. 5. Clinical deterioration or disease progression. 6. Development of AIDS-defining condition. 7. Further participation deemed detrimental to health. 8. Pregnancy. 9. Need for systemic cytotoxic therapy for a newly diagnosed malignancy. PARTICIPATING UNITS ------------------- 0000002722: Cedars Sinai Medical Center 8700 Beverly Boulevard / Becker 220 Los Angeles, CA 90048 Contact: Jacqui Pitt (310) 855-3755 OPEN 960124. 0000003359: University of Kansas School of Medicine 1010 North Kansas Street Wichita, KS 67214 Contact: Dalrona Harrison (316) 261-2655 OPEN 960306. 0000003535: Harper Hospital / Wayne State Univ School of Medicine 4201 St Antoine / Section 6F Detroit, MI 48201 Contact: Dr Rodger MacArthur (313) 745-4483 OPEN 960417. 0000003498: Community Research Initiative on AIDS 275 7th Avenue / 20th Floor New York, NY 10001