Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

• Status: Completed
• Trial end date: 2012-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.

Criteria

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