(ATN) "Parallel Track" d4T Access About to Begin

(ATN) "Parallel Track" d4T Access About to Begin

AIDS Treatment News #159, September 18, 1992
John S. James

Bristol-Myers Squibb will soon begin a large parallel-track program which will provide d4T to persons with advanced HIV infection who have no other option for antiretroviral treatment because they cannot tolerate (or have failed to respond to) AZT and ddI. Details have not been released, pending final approval by the FDA, and some criteria for the program may not yet have been determined. Here is what we have learned so far:

* The original proposal called for this program to be open only to persons with T-helper counts of 300 or less; however, there is a strong push to raise this limit to 500.

* Patients will be randomly assigned to a high dose (somewhat more than 1.0 mg/kg/day, divided into two daily doses), or a low dose which is half that much. Dosage will be adjusted by body weight.

* Efforts will be made to facilitate use of this program by persons receiving their care in public clinics, as well as those who have private physicians.

Physicians who want to receive information about this program when it is ready should call the Bristol-Myers d4T Information Line, 800/842-8036, 7:30 a.m. to 4:00 p. m. Central time.

920904
ATN15902

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