Clinical Trials


Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

This study has been completed
Valeant Pharmaceuticals International, Inc.

Information provided by (Responsible Party)
Valeant Pharmaceuticals International, Inc. Identifier

First received: June 13, 2011
Last updated: May 17, 2013
Last Verified: July 2012
History of Changes


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.

Condition Intervention Phase
HIV Enteropathy
Diarrhea With HIV

Drug : Crofelemer
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label Evaluation of the Safety and Tolerability of Crofelemer in HIV-Positive Subjects With Diarrhea

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures

  • Incidence of treatment-emergent AEs and serious adverse events (SAEs). [ Time Frame: 48 weeks ]

Enrollment: 251
Study Start Date: June 2011
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Crofelemer

Drug: Crofelemer

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



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01374490


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

Sponsors and Collaborators

Valeant Pharmaceuticals International, Inc.
More Information

More Information

Responsible Party: Valeant Pharmaceuticals International, Inc. Identifier: NCT01374490   History of Changes  
Other Study ID Numbers: CFHD3092  
Study First Received: June 13, 2011  
Last Updated: May 17, 2013  

Keywords provided by Valeant Pharmaceuticals International, Inc.:

HIV positive
HIV associated diarrhea

Additional relevant MeSH terms:
Intestinal Diseases
HIV Enteropathy processed this data on July 20, 2018
This information is provided by