Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
This study is ongoing, but not recruiting participants.
Sponsor:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01374490
First received: June 13, 2011
Last updated: July 5, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Enteropathy Diarrhea With HIV |
Drug: Crofelemer |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Open-Label Evaluation of the Safety and Tolerability of Crofelemer in HIV-Positive Subjects With Diarrhea |
Resource links provided by NLM:
Further study details as provided by Salix Pharmaceuticals:
Primary Outcome Measures:
- Incidence of treatment-emergent AEs and serious adverse events (SAEs). [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2011 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Crofelemer |
Drug: Crofelemer
Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374490
Locations
| United States, Arizona | |
| Phoenix, Arizona, United States, 85006 | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72207 | |
| United States, California | |
| Bakersfield, California, United States, 93301 | |
| Beverly Hills, California, United States, 90211 | |
| Los Angeles, California, United States, 90015 | |
| San Diego, California, United States, 92120 | |
| United States, Florida | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Miami, Florida, United States, 33180 | |
| Miami Beach, Florida, United States, 33139 | |
| Wilton Manors, Florida, United States, 33305 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30318 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60654 | |
| Chicago, Illinois, United States, 60607 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| Santa Fe, New Mexico, United States, 87505 | |
| United States, New York | |
| New York, New York, United States, 10018 | |
| Rochester, New York, United States, 14607 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97210 | |
| United States, Texas | |
| Houston, Texas, United States, 77004 | |
Sponsors and Collaborators
Salix Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Salix Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01374490 History of Changes |
| Other Study ID Numbers: | CFHD3092 |
| Study First Received: | June 13, 2011 |
| Last Updated: | July 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Salix Pharmaceuticals:
|
HIV + HIV positive HIV associated diarrhea AIDS Diarrhea |
Additional relevant MeSH terms:
|
Diarrhea Intestinal Diseases HIV Enteropathy Signs and Symptoms, Digestive Signs and Symptoms Gastrointestinal Diseases Digestive System Diseases HIV Infections |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on March 07, 2013
