Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
- Registration Number
- NCT01374490
- Lead Sponsor
- Bausch Health Americas, 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Crofelemer Crofelemer -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). 48 weeks
- Secondary Outcome Measures
Name Time Method