NCT01374490

Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Enteropathy
• Diarrhea With HIV

Interventions

Type	Name	Description
DRUG	Crofelemer	Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.

Timeline

• Start date: 2011-06-07
• Primary completion: 2012-10-31
• Completion: 2012-10-31
• First posted: 2011-06-16
• Last updated: 2020-08-31
• Results posted: 2020-08-17

Locations

21 sites across 1 country: United States