Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01374490
Recruitment Status : Completed
First Posted : June 16, 2011
Last Update Posted : May 20, 2013
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Enteropathy Diarrhea With HIV Drug: Crofelemer Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
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
Study Start Date : June 2011
Actual Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea HIV/AIDS
Drug Information available for: Crofelemer

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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Responsible Party: Valeant Pharmaceuticals International, Inc. Identifier: NCT01374490     History of Changes
Other Study ID Numbers: CFHD3092
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: May 20, 2013
Last Verified: July 2012

Keywords provided by Valeant Pharmaceuticals International, Inc.:
HIV positive
HIV associated diarrhea

Additional relevant MeSH terms:
Intestinal Diseases
HIV Enteropathy
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases