To: JOHN W. who wrote (3861 ) 2/23/1998 9:07:00 PM From: Oliver & Co Respond to of 6136
February 23, 1998 ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ NEW INFORMATION FROM ACTIS The AIDS Clinical Trials Information Service (ACTIS) is a resource service providing current information on federally and privately sponsored clinical trials for AIDS patients and others infected with HIV.ÿ This service is a Public Health Service project collaboratively sponsored 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. A description of a clinical trial recently added to the ACTIS database is provided below. For more information, call the ACTIS toll-free number to talk with a health specialist.ÿ 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. ÿÿÿÿÿÿÿÿÿÿÿÿ AIDS CLINICAL TRIALS INFORMATION SERVICE ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ 1-800-TRIALS-A ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ (1-800-874-2572) ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ FAX: 1-301-519-6616 ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ TTY: 1-800-243-7012 ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ International Line: 1-301-519-0459 ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ E-mail: actis@cdcnac.org ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ Web Site: actis.org ***************************************************************** 1) FDA 228E: An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) Plus Nelfinavir (NFV), Didanosine (ddI), and Stavudine (d4T) in Triple and Quadruple Treatment Regimens in HIV-1 Infected Individuals. ***************************************************************** PROTOCOL NUMBER:ÿ FDA 228E. TITLE: An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) Plus Nelfinavir (NFV), Didanosine (ddI), and Stavudine (d4T) in Triple and Quadruple Treatment Regimens in HIV-1 Infected Individuals. PHASE: Unspecified. DISEASE STATUS: Patients must have the following symptoms and conditions: 1. HIV-1 positive. 2. CD4 count >= 50. 3. HIV-1 RNA levels >= 20,000. PATIENT INCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: 1. HIV-1 positive. 2. CD4 count >= 50. 3. HIV-1 RNA levels >= 20,000. [Refer to Laboratory values for additional requirements.] AGE: 18 Years - 99 Years. SEX: M. F. PRIOR MEDICATION: Allowed: Less than one month of treatment with didanosine. LABORATORY VALUES AT ENTRY -------------------------- CD4 (T4 CELL) COUNT:ÿÿÿÿ >= 50 cells/mm3. ( 50 - 100 - 200 - 300 ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ - 400 - 500 - 600 - 700 - 800 - plus ). OTHER LABORATORY VALUES: HIV-1 RNA >= 20,000 copies/mL. PATIENT EXCLUSION CRITERIA -------------------------- SPECIFICATION CRITERIA: [Refer to Laboratory values for additional requirements.] AGE: 01 Days - 17 Years. PRIOR MEDICATION: Excluded: 1. Stavudine. 2. Protease inhibitors, including nelfinavir. 3. Non-nucleoside reverse transcriptase inhibitors. 4. One month or greater treatment with didanosine. GENERIC DRUG NAME ----------------- Drug 1: Delavirdine mesylate. Antiretroviral. Drug 2: Nelfinavir. Protease inhibitor. Drug 3: Didanosine. Antiretroviral. Drug 4: Stavudine. Antiretroviral. DRUG COMPANIES -------------- Drug 1: Pharmacia and Upjohn Company 7000 Portage Road Kalamazoo, MI 49001 Contact: Drug Informationÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ (800) 432-4702. Drug 2: Agouron Pharmaceuticals Incorporated 10350 North Torrey Pines Road / Suite 100 La Jolla, CA 92037 Contact: Unspecifiedÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ (888) 847-2237. Drug 3: Bristol - Myers Squibb Company PO Box 4500 Princeton, NJ 08543-4500 Contact: Drug Informationÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ (800) 662-7999. Drug 4: Bristol - Myers Squibb Company PO Box 4500 Princeton, NJ 08543-4500 Contact: Drug Informationÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ (800) 662-7999. END POINT --------- Safety, tolerability, pharmacokinetics, and antiviral efficacy. PARTICIPATING UNITS ------------------- 0000001001: Pharmacia and Upjohn Company 7000 Portage Road Kalamazoo, MI 49001 Contact: Drug Informationÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ (800) 432-4702 OPEN 980218. ***************************************************************** ÿÿÿÿ The AIDSNews Mailing List is maintained by the CDC National Center for HIV, STD and TB Prevention. Regular postings include the CDC NCHSTP Daily News Update, conference announcements, clinical trials information, current funding opportunities, and selected MMWR articles. To SUBSCRIBE, send the command "subscribe aidsnews firstname lastname" to the address listproc@aspensys.com. To UNSUBSCRIBE, send the command "unsubscribe aidsnews" to the address listproc@aspensys.com. If you need assistance, please contact aidsinfo@cdcnac.org. ÿÿÿÿ ***************************************************************** John, these are very potent, and well tolerated regimens. I have used them. One good thing is that Viracept can be used in the BID dose very well, because Rescriptor increases the area under the curve.