Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
Information source: Salix Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Enteropathy; Diarrhea With HIV
Intervention: Crofelemer (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Salix Pharmaceuticals
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.
Clinical Details
Official title: A Phase 3, Multicenter, Open-Label Evaluation of the Safety and Tolerability of Crofelemer in HIV-Positive Subjects With Diarrhea
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of treatment-emergent AEs and serious adverse events (SAEs).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Phoenix, Arizona 85006, United States
Little Rock, Arkansas 72207, United States
Bakersfield, California 93301, United States
Beverly Hills, California 90211, United States
Los Angeles, California 90015, United States
San Diego, California 92120, United States
Fort Lauderdale, Florida 33308, United States
Fort Lauderdale, Florida 33316, United States
Miami Beach, Florida 33139, United States
Miami, Florida 33180, United States
Wilton Manors, Florida 33305, United States
Atlanta, Georgia 30318, United States
Chicago, Illinois 60607, United States
Chicago, Illinois 60654, United States
Detroit, Michigan 48201, United States
Santa Fe, New Mexico 87505, United States
New York, New York 10018, United States
Rochester, New York 14607, United States
Cincinnati, Ohio 45267, United States
Portland, Oregon 97210, United States
Houston, Texas 77004, United States
Additional Information
Starting date: June 2011
Last updated: May 17, 2013
|