Phase 3
N=374
Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
HIV Associated Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT00547898 ↗Enrolled (actual)
374
Serious AEs
1.7%
Results posted
Sep 2020
Primary outcome: Primary: Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo — 24; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Crofelemer 125 mg (Drug); Crofelemer 250 mg (Drug); Crofelemer 500 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo |
24; 11 | — |
Summary
This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.
Eligibility Criteria
Inclusion Criteria
- History of HIV-1 infection confirmed by standard serological tests
- Stable medical regimen for treatment of HIV disease and associated conditions for at least 4 weeks prior to screening
- Patient-reported history of diarrhea, defined as either persistently loose stools despite regular ADM use, or one or more watery bowel movements per day without regular ADM use, of at least 1 month duration
- Colonoscopy within the past 5 years if ≥ 50 years of age.
Exclusion Criteria
- Pregnancy or breast-feeding
- Current or past gastrointestinal (GI) medical or surgical conditions
- Use of certain opiate pain medication within 2 weeks of screening
- Use of an antibiotic within 2 weeks prior to screening, with the exception of stable antibiotic therapy for prophylactic treatment of infection or an HIV-associated condition
- CD4 counts < 100 cells/mm3
- Previous randomization into this study, or into any other crofelemer study
Data sourced from ClinicalTrials.gov (NCT00547898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.