Trial record 1 of 52 for:    " June 01, 2011":" July 01, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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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
  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 ]

Enrollment: 251
Study Start Date: June 2011
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 60607
Chicago, Illinois, United States, 60654
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: May 17, 2013
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:
HIV Enteropathy
HIV Infections
Diarrhea
Digestive System Diseases
Gastrointestinal Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Intestinal Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Signs and Symptoms, Digestive
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014