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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
Will Treatment IND for Aerosolized Pentamidine Have Effect?

March 2, 1989
AIDS Alert (03/89) Vol. 4, No. 3, P. 37

The Food and Drug Administration's (FDA) decision to grant treatment IND (investigational new drug) status to aerosolized pentamidine is merely a technicality, say some physicians who have used the drug on their AIDS patients for a year or more. Others, such as Donald Abrams of San Francisco General Hospital, said, "The treatment IND will have more impact in smaller communities," where doctors may be "more cautious and wait for some sort of stamp of approval." Even in big cities such as San Francisco, however, Abrams said, hospitals and health maintenance organizations that would not use the drug when it was experimental will offer it now. The treatment IND also provides a standard protocol for the use of the drug. The protocol, which Abrams helped develop, calls for aerosolized administration of 300 mg of pentamidine once every four weeks. Patients who have had Pneumocystis carinii pneumonia or whose T4 cell counts are less than 200 per cubic milliliter of blood are eligible for the protocol. Physicians taking part in the new protocol must report the results to the FDA.

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