Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

ClinicalTrials.gov ID: NCT01374490

Public ClinicalTrials.gov record NCT01374490. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 22, 2026, 5:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01374490
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Bausch Health Americas, Inc.; Industry
Enrollment: 250 participants

Conditions and interventions

Conditions

Interventions

Crofelemer Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 7, 2011 (Actual)
Primary completion: Oct 31, 2012 (Actual)
Completion: Oct 31, 2012 (Actual)
Last update posted: Aug 31, 2020

2011 – 2012

United States locations

U.S. sites: 21
U.S. states: 12
U.S. cities: 19

Facility	City	State	ZIP	Site status
Not listed	Phoenix	Arizona	85006	—
Not listed	Little Rock	Arkansas	72207	—
Not listed	Bakersfield	California	93301	—
Not listed	Beverly Hills	California	90211	—
Not listed	Los Angeles	California	90015	—
Not listed	San Diego	California	92120	—
Not listed	Fort Lauderdale	Florida	33308	—
Not listed	Fort Lauderdale	Florida	33316	—
Not listed	Miami	Florida	33180	—
Not listed	Miami Beach	Florida	33139	—
Not listed	Wilton Manors	Florida	33305	—
Not listed	Atlanta	Georgia	30318	—
Not listed	Chicago	Illinois	60607	—
Not listed	Chicago	Illinois	60654	—
Not listed	Detroit	Michigan	48201	—
Not listed	Santa Fe	New Mexico	87505	—
Not listed	New York	New York	10018	—
Not listed	Rochester	New York	14607	—
Not listed	Cincinnati	Ohio	45267	—
Not listed	Portland	Oregon	97210	—
Not listed	Houston	Texas	77004	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01374490, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 31, 2020 · Synced Oct 22, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01374490 live on ClinicalTrials.gov.

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