T-20 small program, cd4 < 50, will enroll November 27 at 3:00 p.m.A small and difficult T-20 expanded-access program will begin receiving phone calls from U.S. physicians on November 27 at 3:00 p.m. Eastern time. The first 56 eligible physicians will be accepted. Each physician must have exactly 3 patients who qualify for this program when they call. The 168 patients accepted will be eligible to receive T-20 when the program starts -- in the first quarter of 2002, depending on drug supply. T-20 is the first member of a new class of anti-HIV drugs called fusion inhibitors, which block the entry of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. into cells. Because it works by a different mechanism than any approved drug, virus resistant to the approved drugs is not expected to be resistant to T-20. However, T-20 resistance can develop when the drug is used, as with the other antiretrovirals. Patients must have a CD4 count CD4 count n. A measure of the number of helper T cells per cubic millimeter of blood, used to analyze the prognosis of patients infected with HIV. under 50, a viral load viral load n. The concentration of a virus, such as HIV, in the blood. viral load, n a measure of the number of virus particles present in the bloodstream, expressed as copies per milliliter. over 10,000, and be at least 16 years old. Physicians are asked to give preference to patients "who have had an AIDS defining opportunistic infection opportunistic infection n. An infection by a microorganism that normally does not cause disease but becomes pathogenic when the body's immune system is impaired and unable to fight off infection, as in AIDS and certain other diseases. , neoplasm neoplasm or tumor, tissue composed of cells that grow in an abnormal way. Normal tissue is growth-limited, i.e., cell reproduction is equal to cell death. or condition AND CD4 lymphocyte lymphocyte: see blood; immunity. lymphocyte Type of leukocyte fundamental to the immune system, regulating and participating in acquired immunity. Each has receptor molecules on its surface that bind to a specific antigen. count <50 cellws/[mm.sup.3], both while on HAART HAART highly active antiretroviral therapy. HAART Highly active antiretroviral therapy, triple combination therapy AIDS The concurrent administration of 2 nucleoside reverse transcriptase inhibitors–eg, AZT and 3TC, and a protease within the last 90 days." T-20 is being developed jointly by Roche Pharmaceuticals and Trimeris, Inc., and is currently in phase III clinical trials. This new program is called Protocol T20-305, "Open Label Safety Study of T-20 in Patients with Advanced HIV Disease who are Unable to Construct a Viable Antiviral Regimen." Physicians interested in this program should make sure that they have a November 2 Dear Doctor letter from Trimeris and Roche, which was sent to 2,000 AIDS-treating physicians on November 2; currently it is on the Web at http://www.hivandhepatitis.com/recent/resistance/l10701a2.html. Also, a physician or patient with questions about T-20 can call Professional Product Information at Roche, 1-800-526-6367, 8:00 a.m. to 6:30 p.m. Eastern time Monday through Friday, either before or after November 27. (Note: This is NOT the number to call starting November 27 at 3:00 P.M.; see the physician letter for complete information.) |
|
||||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion