Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

Completed · Phase 3

Conditions studied: HIV Enteropathy, Diarrhea With HIV

In brief

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.

Key facts

Study ID

NCT01374490

Run by

Bausch Health Americas, Inc.

People needed

250

Starts

2011-06-07

Expected to finish

2012-10-31

Last updated by the study team

2020-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Beach, Florida, United States
• Study site — Wilton Manors, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Detroit, Michigan, United States
• Study site — Santa Fe, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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