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

Phase 3

Completed

• Conditions: HIV Associated Diarrhea
• Interventions: Drug: Crofelemer 125 mg; Drug: Crofelemer 250 mg; Drug: Placebo; Drug: Crofelemer 500 mg

• Registration Number: NCT00547898
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-21
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Primary Completion: 2011-01-27
• Study Completion: 2011-07-11
• Results First Submitted: 2017-12-14
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Results First Posted: 2020-09-03
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

• History of HIV-1 infection confirmed by standard serological tests
• Stable medical regimen for treatment of HIV disease and associated conditions for at least 4 weeks prior to screening
• Patient-reported history of diarrhea, defined as either persistently loose stools despite regular ADM use, or one or more watery bowel movements per day without regular ADM use, of at least 1 month duration
• Colonoscopy within the past 5 years if ≥ 50 years of age.

Exclusion Criteria

• Pregnancy or breast-feeding
• Current or past gastrointestinal (GI) medical or surgical conditions
• Use of certain opiate pain medication within 2 weeks of screening
• Use of an antibiotic within 2 weeks prior to screening, with the exception of stable antibiotic therapy for prophylactic treatment of infection or an HIV-associated condition
• CD4 counts < 100 cells/mm3
• Previous randomization into this study, or into any other crofelemer study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crofelemer 125 mg	Crofelemer 125 mg	-
Crofelemer 250 mg	Crofelemer 250 mg	-
Placebo	Placebo	-
Crofelemer 500 mg	Crofelemer 500 mg	-

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo	31 days