Back to resultsSafety and Tolerability of Crofelemer for HIV-Associated Diarrhea
Primary Purpose
HIV Enteropathy, Diarrhea With HIV
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Crofelemer
Sponsored by
About this trial
This is an interventional treatment trial for HIV Enteropathy focused on measuring HIV +, HIV positive, HIV associated diarrhea, AIDS, Diarrhea
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Crofelemer
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Secondary Outcome Measures
Full Information
NCT ID
NCT01374490
First Posted
June 13, 2011
Last Updated
August 14, 2020
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01374490
Brief Title
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
Official Title
A Phase 3, Multicenter, Open-Label Evaluation of the Safety and Tolerability of Crofelemer in HIV-Positive Subjects With Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 7, 2011 (Actual)
Primary Completion Date
October 31, 2012 (Actual)
Study Completion Date
October 31, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Enteropathy, Diarrhea With HIV
Keywords
HIV +, HIV positive, HIV associated diarrhea, AIDS, Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crofelemer
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Crofelemer
Intervention Description
Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72207
Country
United States
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Wilton Manors
State/Province
Florida
ZIP/Postal Code
33305
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
12. IPD Sharing Statement
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Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
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