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Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

Information source: Salix Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Enteropathy; Diarrhea With HIV

Intervention: Crofelemer (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Salix Pharmaceuticals

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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of treatment-emergent AEs and serious adverse events (SAEs).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Phoenix, Arizona 85006, United States

Little Rock, Arkansas 72207, United States

Bakersfield, California 93301, United States

Beverly Hills, California 90211, United States

Los Angeles, California 90015, United States

San Diego, California 92120, United States

Fort Lauderdale, Florida 33308, United States

Fort Lauderdale, Florida 33316, United States

Miami Beach, Florida 33139, United States

Miami, Florida 33180, United States

Wilton Manors, Florida 33305, United States

Atlanta, Georgia 30318, United States

Chicago, Illinois 60607, United States

Chicago, Illinois 60654, United States

Detroit, Michigan 48201, United States

Santa Fe, New Mexico 87505, United States

New York, New York 10018, United States

Rochester, New York 14607, United States

Cincinnati, Ohio 45267, United States

Portland, Oregon 97210, United States

Houston, Texas 77004, United States

Additional Information

Starting date: June 2011
Last updated: May 17, 2013

Page last updated: August 20, 2015

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