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Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

NCT01374490 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2020-08-31

Study results available
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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.

Conditions

  • HIV Enteropathy
  • Diarrhea With HIV

Interventions

DRUG

Crofelemer

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

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-07
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01374490 on ClinicalTrials.gov