Date: Mon, 03 Mar 97 16:22:06 EST From: "David Radune" Subject: New Information from ACTIS: FDA 229F & FDA 245C March 3, 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 229F. TITLE: An Open Label, Non-Comparative Study of Saquinavir-SGC in combination with Zidovudine (AZT) and Lamivudine (3TC) in the Treatment of HIV-1 Infected Patients With No Previous Anti-Retroviral Drug Therapy. PHASE: Phase III. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. Plasma HIV-1 RNA titers > 10,000 copies/ml. 2. CD4 cell count > 100 cells/mm3. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Plasma HIV-1 RNA titers > 10,000 copies/ml. 2. CD4 cell count > 100 cells/mm3. [Refer to Laboratory values for additional requirements.] AGE: 16 Years - 99 Years. SEX: M. F. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: > 100 cells/mm3. (100 - 200 - 300 - 400 - 500 - 600 - 700 - 800 - plus) OTHER LABORATORY VALUES: Plasma HIV-1 RNA titers > 10,000 copies/ml. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 15 Years. PRIOR MEDICATION: Excluded: Previous anti-retroviral drug therapy. CO-EXISTING CONDITIONS OR DISEASES: Patients with any of the following conditions will be excluded: 1. Any prior anti-retroviral drug therapy. GENERIC DRUG NAME ----------------- Drug 1: Zidovudine. Antiretroviral. Drug 2: Lamivudine. Antiretroviral. Drug 3: Saquinavir mesylate. Antiretroviral. DRUG TRADE NAME --------------- Drug 1: AZT. Drug 2: 3TC. Drug 3: Invirase. DRUG COMPANIES -------------- Drug 1: Glaxo Wellcome 5 Moore Drive / PO Box 13398 Research Triangle Park, NC 27709 Contact: Dept of Consumer Affairs (800) 437-0992 X 7900. 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. Drug 3: Hoffmann - La Roche Incorporated 340 Kingsland Street Nutley, NJ 07110-1199 Contact: Professional Services (800) 526-6367. END POINT --------- Safety and efficacy. PARTICIPATING UNITS ------------------- 0000003826: AIDS Healthcare Foundation Labs 8631 West Third Street / Suite 740E Los Angeles, CA 90048 Contact: Dr Charles Farthing (213) 766-2326 OPEN 970204. 0000003825: Urgent Care Center / North Broward Hospital District 300 SE 17th Street Fort Lauderdale, FL 33316 Contact: Dr Michael Sension (954) 355-4400 OPEN 970204. ***************************************************************** PROTOCOL NUMBER: FDA 245C. TITLE: A Phase II Safety and Activity Study of Ritonavir in the Treatment of HIV Associated Cutaneous Kaposi's Sarcoma PHASE: Phase II. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. Documentation of a positive ELISA test for HIV with a confirmatory test. 2. Biopsy proven, cutaneous or oropharyngeal Kaposi's sarcoma. Patients should have at least 5 measurable, cutaneous lesions that have not received prior intralesional chemotherapy, radiotherapy, or topical treatment. NOTE: No facial lesions will be used for biopsy, however facial lesions may be counted as any of the five measurable lesions . PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Documentation of a positive ELISA test for HIV with a confirmatory test. 2. Biopsy proven, cutaneous or oropharyngeal Kaposi's sarcoma. 3. Vital signs, physical examination and laboratory assessments that exhibit no evidence of an acute illness. 4. Patients must agree to report all current medications to the primary investigator and obtain prior permission to use them when feasible. [Refer to Laboratory values for additional requirements.] AGE: 18 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Negative pregnancy test. Abstinence or agree to use barrier methods of birth control / contraception during the study. Not breast-feeding. Not pregnant. CONCURRENT TREATMENT: Allowed: Localized radiotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions. CONCURRENT MEDICATION: Allowed: 1. Patients may receive oral acyclovir and may continue prophylactic treatment for PCP, fungal infection, MAC and toxoplasmosis. 2. Topical treatment and intralesional chemotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions. LABORATORY VALUES AT ENTRY -------------------------- HEMOGLOBIN: >= 8 g/dl. PLATELET COUNT: >= 50000 platelets/mm3. CD4 (T4 CELL) COUNT: Unspecified cells/mm3. BILIRUBIN: <= 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: Absolute neutrophil count >= 750 cells/mL. Triglyceride level < 400 mg/dl/ Serum amylase <= ULN (except those with normal pancreatic amylase). PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with any of the following prior conditions are excluded: 1. History of psychiatric illness which is currently medically significant. 2. History of pancreatitis. [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Breast-feeding. Positive pregnancy test. Pregnant. No abstinence or no agreement to use barrier methods of birth control / contraception during the study. RISK BEHAVIOR: Excluded: Active substance abuse. CONCURRENT TREATMENT: Excluded: Radiotherapy for Kaposi's sarcoma. PRIOR MEDICATION: Excluded: 1. All antiretrovial therapy within 2 weeks prior to the start of the treatment phase of the study. 2. Systemic chemotherapy of interferon within 30 days prior to study entry. 3. Previous treatment with a protease inhibitor. CONCURRENT MEDICATION: Excluded: 1. Anitretroviral therapy. 2. Protease inhibitor therapy. 3. Antiviral agent (e.g. oral ganciclovir or Foscarnet) or prophylactic medication for an AIDS defining illness which the patient cannot be removed from. 4. Chemotherapy for Kaposi's sarcoma. 5. Treatment with any medications that may interact with ritonavir. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms and conditions are excluded: 1. Evidence of pulmonary Kaposi's sarcoma. 2. Positive urine screen for recreational drugs. 3. Current participation in another antiviral research study. 4. Investigator anticipates poor patient compliance with the protocol. 5. Patient has any condition that, in the investigator's opinion, may obscure the proprt observation of the safety or activity of ritonavir. GENERIC DRUG NAME ----------------- Drug 1: Ritonavir. Protease inhibitor. DRUG TRADE NAME --------------- Drug 1: Norvir. DRUG COMPANIES -------------- Drug 1: Abbott Laboratories One Abbott Park Road Abbott Park, IL 60064 Contact: Ritonavir Information (800) 441-4987. END POINT --------- Safety. PARTICIPATING UNITS ------------------- 0000003831: UCLA School of Medicine 10833 LeConte Avenue / BH412 CHS Los Angeles, CA 90095 Contact: Dr Ronald Mitsuyasu (310) 206-8359 OPEN 970205. 0000002524: Saint Vincent's Hospital Medical Centre 367 Victoria Street Sydney, AS NSW 2010 Contact: Dr David Cooper 61 (02) 332-4648 OPEN 970205. 0000003830: Prince Henry's Hospital / Medical Oncology High Street / Randwick Sydney, AS NSW 2031 Contact: Dr Craig Lewis 61 (02) 382-2585 OPEN 970205. *****************************************************************