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NCT01374490 · ClinicalTrials.gov registry record · Phase 3

Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

A Phase 3 study of HIV Enteropathy and Diarrhea With HIV, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
250
Enrollment target
20
Study locations

NCT01374490: Completed Phase 3 study of HIV Enteropathy and Diarrhea With HIV, sponsored by Bausch Health Americas.

NCT01374490 is a Phase 3 study of HIV Enteropathy and Diarrhea With HIV that has completed, run by Bausch Health Americas. The registered enrollment target is 250 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01374490, a Phase 3 study of HIV Enteropathy and Diarrhea With HIV, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
250 participants
Enrollment target
20
Study locations

Study 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 Studied

HIV Enteropathy Diarrhea With HIV

Interventions

  • DRUG Crofelemer

Study Locations (20)

Florida

  • - Fort Lauderdale
  • - Fort Lauderdale
  • - Miami
  • - Miami Beach
  • - Wilton Manors

California

  • - Bakersfield
  • - Beverly Hills
  • - Los Angeles
  • - San Diego

Illinois

  • - Chicago
  • - Chicago

New York

  • - New York
  • - Rochester

Arizona

  • - Phoenix

Arkansas

  • - Little Rock

Georgia

  • - Atlanta

Michigan

  • - Detroit

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2011-06-07
Est. Completion 2012-10-31
Phase Phase 3
Bausch Health Americas

168 total trials

What the finished NCT01374490 record still lists

NCT01374490 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).

The record links to 2 conditions, with HIV Enteropathy appearing as the primary indexed condition, and to 1 intervention - of which Crofelemer is the first listed.

NCT01374490 names 20 study sites across 11 states, led by Florida, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT01374490 about?

NCT01374490 is a clinical study titled "Safety and Tolerability of Crofelemer for HIV-Associated 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.

What is the current status of trial NCT01374490?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2011-06-07. Estimated completion is 2012-10-31.

What conditions does trial NCT01374490 study?

This clinical trial studies the following conditions: HIV Enteropathy, Diarrhea With HIV.

What interventions are being tested in trial NCT01374490?

The interventions under investigation include: Crofelemer (DRUG).

Who is sponsoring clinical trial NCT01374490?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01374490 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT01374490's enrollment target sits among peer trials

250 1249th of 2000 higher than 735 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01374490, the US trial registry maintained by the National Library of Medicine. NCT01374490 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.