Clinical Trial: Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Multicenter, Open-Label Evaluation of the Safety and Tolerability of Crofelemer in HIV-Positive Subjects With Diarrhea

Brief Summary: This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.

Detailed Summary:
Sponsor: Valeant Pharmaceuticals International, Inc.

Current Primary Outcome: Incidence of treatment-emergent AEs and serious adverse events (SAEs). [ Time Frame: 48 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Valeant Pharmaceuticals International, Inc.

Dates:
Date Received: June 13, 2011
Date Started: June 2011
Date Completion:
Last Updated: May 17, 2013
Last Verified: July 2012