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T-20 Small Program, CD4 <50, Will Enroll November 27 at 3:00 P.M.

By John S. James

October 26, 2001

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 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 under 50, a viral load 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, neoplasm or condition AND CD4 lymphocyte count <50 cells/mm3, both while on HAART 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 here. 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.)

ISSN # 1052-4207

Copyright 2001 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.

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