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HIV/AIDS Therapy

Napo completes feasibility assessment of crofelemer for chronic diarrhea in HIV/AIDS

Published in Law and Health Weekly, January 20th, 2007

Napo Pharmaceuticals, Inc has completed a feasibility assessment at four U.S. investigative sites in preparation for a phase III pivotal trial of crofelemer for chronic diarrhea in people living with HIV/AIDS (CRO-HIV).

The objectives of the Institutional Review Board-approved study were to estimate potential enrolment rates using patient inclusion and exclusion criteria resembling those to be employed in the phase III CRO-HIV trial; to assess patient compliance by completing a daily diarrhea symptom diary; and to assess the ability of patients to abstain from medications prohibited by the protocol, including concomitant anti-diarrhea medications. Fifty-five...

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