Date: Wed, 05 Mar 97 16:05:53 EST From: "David Radune" Subject: New Information from ACTIS 03/05/97: FDA 262A & ACTG 305 March 5, 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 262A. TITLE: Further Evaluation of Thalidomide'a Ability to Potentiate the Immune Response to HIV Infected Patients. PHASE: Pilot Study. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. HIV infection. 2. CD4+ cell count >= 200/microliter or > 14% CD4+ cells in peripheral blood. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. HIV infection. 2. CD4+ cell count >= 200/microliter or > 14% CD4+ cells in peripheral blood. 3. Willingness to commit to the study duration and agree to abide to the time table for entry into the study, ingestion of thalidomide and follow-up. [Refer to Laboratory values for additional requirements.] AGE: 18 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: No future reproduction. CONCURRENT MEDICATION: Required: 10 of the 20 patients must be on antiretroviral therapy and the other 10 will be subjects who have decided not to be on any antiretroviral drug prior to enrollment into this study and do not plan to start such treatment during the study period. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT: >= 200 cells/mm3. (200 - 300 - 400 - 500 - 600 - 700 - 800) PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients with any of the following prior conditions are excluded: HIV related pre-existing peripheral neuropaty. [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Future reproduction. PRIOR MEDICATION: Excluded: Patients using systemic steroidal anti inflammatory drugs or pentoxifylline within 10 days of dosing with thalidomide. CO-EXISTING CONDITIONS OR DISEASES: Patients with any of the following conditions or symptoms are excluded: 1. Fertile females. 2. Patients who participated in a clinical study involving a new drug or device with the last 2 months or the period of time equivalent to seven times the half life of the study drug, whichever is longer. GENERIC DRUG NAME ----------------- Drug 1: Thalidomide. Immunomodulator. DRUG COMPANIES -------------- Drug 1: Andrulis Pharmaceuticals Corporation 11800 Baltimore Avenue Beltsville, MD 20705 Contact: Dr Peter Andrulis (301) 419-2400. PARTICIPATING UNITS ------------------- 0000003837: Ochsner Clinic 1514 Jefferson Highway New Orleans, LA 70102 Contact: G A Pankey (504) 838-4005 OPEN 961201. ***************************************************************** PROTOCOL NUMBER: NIAID ACTG 305. TITLE: A Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease. PHASE: Phase I / Phase II. DISEASE STATUS: Patients must have the following conditions and symptoms: 1. HIV infection documented by ELISA and confirmed by Western Blot at any time prior to entry. 2. Encephalopathy or radiculomyelitis. 3. CSF positive for CMV by PCR (obtained by a non-traumatic spinal tap [<100 rbc/mm3]). PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: Patients must have: 1. Documented HIV infection. 2. Encephalopathy or radiculomyelitis. 3. CSF positive for CMV by PCR. 4. Signed informed consent from a parent or legal guardian for patients < 18 years. 5. CSF cytological analysis should be obtained at the time of enrollment or within 2 weeks prior to enrollment. NOTE: Co-enrollment is encouraged where study procedures do not conflict. Protocols investigating antiviral regimens with potential activity against CMV or other human herpes viruses will be ineligible. [Refer to Laboratory values for additional requirements.] AGE: 13 Years - 99 Years. SEX: M. F. REPRODUCTIVE SPECIFICATION: Not breast-feeding. Not pregnant. Abstinence or effective method of birth control / contraception during the study and for 90 days after. CONCURRENT MEDICATION: Allowed: Patients with treated, stable toxoplasmosis encephalitis with documented stable CT or MR scans may be enrolled if maintenance suppressive therapy is continued. LABORATORY VALUES AT ENTRY -------------------------- PLATELET COUNT: >= 20,000 platelets/mm3. CD4 (T4 CELL) COUNT: Unspecified cells/mm3. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. REPRODUCTIVE SPECIFICATION: Breast-feeding. Pregnant. No abstinence or no agreement to use effective method of birth control during study and for 90 days after. CONCURRENT MEDICATION: Excluded: 1. Patients on prophylactic antiviral therapy at the time of study enrollment will not be allowed to continue this medication during the study. In the event of the appearance of HSV or VZV infections after enrollment in the study that require systemic therapy, acyclovir or other appropriate medication may be instituted. 2. Patients may not receive ZDV therapy during the initial 4 weeks of the study. Concurrent ZDV therapy will be started during maintenance therapy if tolerated. Bone marrow sparing antiretroviral therapy may be used at the investigator's discretion. NOTE: Concurrent medications should be kept to a minimum because of possible interference with the assessment of both safety and pharmacokinetics. But medications absolutely necessary for the subjects's welfare may be administered at the discretion of the investigator. CO-EXISTING CONDITIONS OR DISEASES: Patients with the following symptoms and conditions are excluded: 1. Active CNS infection or malignancy, other than due to CMV or HIV. 2. A positive CSF VDRL. 3. Any evidence of active disease such as a substantial increase in cryptococcal antigen titer or positive culture. However, patients may be enrolled with stable, treated cryptococcal meningitis. 4. A dermatomal or disseminated varicella-zoster infection within 30 days prior to enrollment. 5. An active, symptomatic systemic infection, other tan HIV or CMV, for which the patient is not receiving stable therapy for at least 30 days. 6. Any other advanced disease likely to cause death in <6 months. 7. Known intolerance to both foscarnet and ganciclovir. 8. Inability to safely perform a lumbar puncture. GENERIC DRUG NAME ----------------- Drug 1: Foscarnet sodium. Antiviral. Drug 2: Ganciclovir. Antiviral. DRUG COMPANIES -------------- Drug 1: Astra USA Incorporated 50 Otis Street / PO Box 4500 Westborough, MA 01581-4500 Contact: Dr Sarah Martin-Munley (508) 366-1100 X 2309. Drug 2: Roche Global Development - Palo Alto 3401 Hill View Avenue Palo Alto, CA 94303 Contact: Roche - Syntex Information (800) 444-4200. END POINT --------- CSF penetration and treatment limiting toxicity. DISCONTINUE TREATMENT --------------------- Treatment may be discontinued for the following reasons: 1. Unacceptable toxicity. 2. Patient requests withdrawl from study. 3. Investigator requests that patient be withdrawn. 4. A presumptively diagnosed patient is determined to be ineligible. 5. If a patient becomes too ill to continue study therapy. 6. Patients who prove to be intolerant to ganciclovir and foscarnet prior to the 2 week clinic visit. PARTICIPATING UNITS ------------------- 0000001376: University of California / San Diego Treatment Center 2760 5th Avenue / Suite 300 San Diego, CA 92103-6325 Contact: Janice Menendez (619) 543-8080 OPEN 970102 ACTU: 0701. 0000001381: San Francisco General Hospital 995 Potrero Avenue / Building 80 / Ward 84 San Francisco, CA 94110-2859 Contact: David Gary (415) 476-9296 X 354 OPEN 970102 ACTU: 0801. 0000001382: San Francisco AIDS Clinic / San Francisco General Hospital 995 Potrero Avenue / Building 80 / Ward 84 San Francisco, CA 94110-2859 Contact: David Gary (415) 476-9296 X 354 OPEN 970102 ACTU: 0802. 0000002265: University of Colorado Health Sciences Center 4200 East 9th Avenue / Colorado ACTU / Campus Box B-163 Denver, CO 80262 Contact: M Graham Ray (303) 372-5535 OPEN 970102 ACTU: 6101. 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 970121 ACTU: 2701. 0000001335: Washington University School of Medicine 4511 Forest Park / Suite 304 St Louis, MO 63108 Contact: Michael Klebert (314) 454-0058 OPEN 970102 ACTU: 2101. 0000001316: Mount Sinai Medical Center One Gustave Levy Place / PO Box 1042 New York, NY 10029 Contact: Dr Eileen Chusid (212) 241-0433 OPEN 960102 ACTU: 1801. 0000002631: MetroHealth Medical Center 2500 MetroHealth Drive Cleveland, OH 44109-1998 Contact: Nancy Frantz (216) 459-5136 OPEN 970130 ACTU: 2503. *****************************************************************