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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
From the Food and Drug Administration: New Protocol for Trimetrexate in"
Nightingale, Stuart L.
October 21, 1988
A new study will enroll AIDS patients with PCP who have not responded to standard treatments (trimethoprim/sulfamethoxazole and parenteral pentamidine) within 14 days or who have failed to respond to one for at least seven days and have developed serious reactions to the other. The patients will take trimetrexate, which under the "Treatment IND" protocol was previously available only to those with serious reactions to both approved drugs. The new study is uncontrolled. The National Institute of Allergy and Infectious Diseases and trimetrexate manufacturer Warner-Lambert Co. are conducting two approved, multicenter studies for patients with the disease who have not responded well to one of the treatments, but have not had serious adverse reactions to the other. Two other studies will compare the new drug with the approved therapies as initial treatments.