NCT00547898

Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea

Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Two-Stage Study to Assess the Efficacy and Safety of 3 Doses of Crofelemer Orally Twice Daily for the Treatment of HIV-Associated Diarrhea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.

Conditions

• HIV Associated Diarrhea

Interventions

Type	Name	Description
DRUG	Crofelemer 125 mg	Crofelemer 125 mg
DRUG	Crofelemer 250 mg	Crofelemer 250 mg
DRUG	Crofelemer 500 mg	Crofelemer 500 mg
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-01-27
• Completion: 2011-07-11
• First posted: 2007-10-23
• Last updated: 2020-09-03
• Results posted: 2020-09-03

Locations

82 sites across 2 countries: United States, Puerto Rico