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

HIV Associated Diarrhea Clinical Trial

— ADVENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547898
• Other study ID #: NP303-101
• Status: Completed
• Phase: Phase 3
• Start date: October 2007
• Est. completion date: July 11, 2011

Study information

• Verified date: August 2020
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: July 11, 2011
• Est. primary completion date: January 27, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• HIV Associated Diarrhea

Intervention

Drug:
• Crofelemer 125 mg
Crofelemer 125 mg
• Crofelemer 250 mg
Crofelemer 250 mg
• Crofelemer 500 mg
Crofelemer 500 mg
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Experiencing Relief of Diarrhea	Relief of diarrhea was defined as two or less watery bowel movements per week during at least two weeks of the treatment phase.	31 days
Primary	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