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
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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.
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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.
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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. |
