CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 250 enrolled
Drug / intervention
Crofelemerdrug
Likely dose
Crofelemer 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01374490
NCT01374490Phase 3Completed
CompareCT.gov

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

Bausch Health Americas, Inc.·interventional·Posted Jun 16, 2011·Updated Aug 31, 2020

In Brief

A Phase 3 clinical trial evaluating Crofelemer for HIV Enteropathy and Diarrhea With HIV. Completed, enrolled 250 participants across 21 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Enteropathy, Diarrhea With HIV
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 16, 2011
Enrollment StartJun 7, 2011
Primary CompletionOct 31, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.0 years ago

Interventions

Crofelemerdrug

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