Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

August 14, 2020 updated by: Bausch Health Americas, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
    • Arkansas
      • Little Rock, Arkansas, United States, 72207
    • California
      • Bakersfield, California, United States, 93301
      • Beverly Hills, California, United States, 90211
      • Los Angeles, California, United States, 90015
      • San Diego, California, United States, 92120
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
      • Fort Lauderdale, Florida, United States, 33316
      • Miami, Florida, United States, 33180
      • Miami Beach, Florida, United States, 33139
      • Wilton Manors, Florida, United States, 33305
    • Georgia
      • Atlanta, Georgia, United States, 30318
    • Illinois
      • Chicago, Illinois, United States, 60654
      • Chicago, Illinois, United States, 60607
    • Michigan
      • Detroit, Michigan, United States, 48201
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
    • New York
      • New York, New York, United States, 10018
      • Rochester, New York, United States, 14607
    • Ohio
      • Cincinnati, Ohio, United States, 45267
    • Oregon
      • Portland, Oregon, United States, 97210
    • Texas
      • Houston, Texas, United States, 77004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female ≥ 18 years old
  • History of HIV-1 infection
  • On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening
  • Self-reported presence of diarrhea necessitating ADM use for at least 4 weeks

Exclusion Criteria:

  • CD4 counts < 100 cells/mm3
  • Oral temperature greater than 38.0° C, or unintentional weight loss of 5.0 kg or greater during the prior 2 months
  • Bright red blood per rectum judged not to be of an anal (e.g., hemorrhoid, fissure) origin
  • Immediate need for GI surgery or intervention for active GI bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Crofelemer
Drug: Crofelemer
Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2011

Primary Completion (Actual)

October 31, 2012

Study Completion (Actual)

October 31, 2012

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

June 15, 2011

First Posted (Estimate)

June 16, 2011

Study Record Updates

Last Update Posted (Actual)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFHD3092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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