Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Two-Stage Study to Assess the Efficacy and Safety of 3 Doses of Crofelemer Orally Twice Daily for the Treatment of HIV-Associated Diarrhea

Conditions
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HIV Associated Diarrhea

Intervention / Treatment
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* Drug: Crofelemer 125 mg
* Drug: Crofelemer 250 mg
* Drug: Crofelemer 500 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Experimental: Crofelemer 125 mg<br> | Drug: Crofelemer 125 mg<br>* Crofelemer 125 mg<br>|
| Experimental: Crofelemer 250 mg<br> | Drug: Crofelemer 250 mg<br>* Crofelemer 250 mg<br>|
| Experimental: Crofelemer 500 mg<br> | Drug: Crofelemer 500 mg<br>* Crofelemer 500 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 31 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, Diarrhea, HIV Associated Diarrhea