Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01374490
First received: June 13, 2011
Last updated: May 17, 2013
Last verified: July 2012

June 13, 2011
May 17, 2013
June 2011
October 2012   (final data collection date for primary outcome measure)
Incidence of treatment-emergent AEs and serious adverse events (SAEs). [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01374490 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
A Phase 3, Multicenter, Open-Label Evaluation of the Safety and Tolerability of Crofelemer in HIV-Positive Subjects With Diarrhea

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Enteropathy
  • Diarrhea With HIV
Drug: Crofelemer
Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
Experimental: Crofelemer
Intervention: Drug: Crofelemer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
Not Provided
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01374490
CFHD3092
No
Salix Pharmaceuticals
Salix Pharmaceuticals
Not Provided
Not Provided
Salix Pharmaceuticals
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP