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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 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. The trial reports 20 study locations across 11 states.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2011-06-07 |
| Est. Completion | 2012-10-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01374490
The ClinicalTrials.gov registry entry for NCT01374490 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.