Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
Launched by BAUSCH HEALTH AMERICAS, INC. · Jun 15, 2011
Trial Information
Current as of June 06, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility 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
About Bausch Health Americas, Inc.
Bausch Health Americas, Inc. is a leading global healthcare company dedicated to improving the lives of patients by developing, manufacturing, and marketing a diverse range of pharmaceutical and over-the-counter products. With a strong focus on eye health, dermatology, and gastrointestinal health, Bausch Health leverages innovative science and technology to address unmet medical needs. Committed to high ethical standards and patient-centric solutions, the company actively engages in clinical trials to advance its product pipeline and enhance therapeutic options. Bausch Health's mission is to empower patients by providing access to effective treatments while fostering a culture of collaboration and excellence within the healthcare community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Santa Fe, New Mexico, United States
Rochester, New York, United States
Detroit, Michigan, United States
San Diego, California, United States
Los Angeles, California, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Miami, Florida, United States
Fort Lauderdale, Florida, United States
Bakersfield, California, United States
Houston, Texas, United States
Chicago, Illinois, United States
Miami Beach, Florida, United States
Atlanta, Georgia, United States
New York, New York, United States
Beverly Hills, California, United States
Wilton Manors, Florida, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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