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