HIV/AIDS

Napo Obtains IRB Approval for Phase 3 Clinical Trial Protocol for Crofelemer in HIV/AIDS Diarrhea Assessment

Published in AIDS Weekly, April 2nd, 2007

Napo Pharmaceuticals, Inc. (LSE: NAPL) announces today that it has received approval from the principal independent review board "IRB" overseeing the pivotal, phase 3 ADVENT study of crofelemer for diarrhoea in people living with HIV/AIDS.

The ADVENT trial (Anti-Diarrhea therapy in HIV disease-Emerging treatmeNT concepts) is a randomized, double-blind, parallel-group, placebo-controlled, two-stage, adaptive design study to assess the efficacy and safety of crofelemer 125mg, 250 mg, and 500 mg oral doses twice daily for the treatment of HIV-Associated Diarrhea. Napo previously met with the United States Food and Drug Administration (FDA) on January 16, 2007 under the...

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Source: AIDS Weekly (2007-04-02)

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