Overview

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