Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

HIV Enteropathy Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label Evaluation of the Safety and Tolerability of Crofelemer in HIV-Positive Subjects With Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374490
• Other study ID #: CFHD3092
• Status: Completed
• Phase: Phase 3
• Start date: June 7, 2011
• Est. completion date: October 31, 2012

Study information

• Verified date: August 2020
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 31, 2012
• Est. primary completion date: October 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea With HIV
• HIV Enteropathy

Intervention

Drug:
• Crofelemer
Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).		48 weeks