Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea (ADVENT)
This study has been completed.
Sponsor:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00547898
First received: October 21, 2007
Last updated: December 22, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Associated Diarrhea |
Drug: Crofelemer 125 mg Drug: Crofelemer 250 mg Drug: Crofelemer 500 mg Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Valeant Pharmaceuticals International, Inc.:
Primary Outcome Measures:
- The primary objective is to determine the proportion of HIV-positive subjects experiencing relief of diarrhea with crofelemer compared to placebo during the placebo-controlled treatment phase. [ Time Frame: 31 days ] [ Designated as safety issue: No ]
- Primary efficacy outcome is two or less watery bowel movements per week during at least two weeks of the treatment phase. [ Time Frame: 31 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 350 |
| Study Start Date: | October 2007 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Placebo |
Drug: Placebo
Placebo
|
| Experimental: Crofelemer 125 mg |
Drug: Crofelemer 125 mg
Crofelemer 125 mg
|
| Experimental: Crofelemer 250 mg |
Drug: Crofelemer 250 mg
Crofelemer 250 mg
|
| Experimental: Crofelemer 500 mg |
Drug: Crofelemer 500 mg
Crofelemer 500 mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00547898
Show 83 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547898
Show 83 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
More Information
Additional Information:
| Responsible Party: | Valeant Pharmaceuticals International, Inc. |
| ClinicalTrials.gov Identifier: | NCT00547898 History of Changes |
| Other Study ID Numbers: | NP303-101 |
| Study First Received: | October 21, 2007 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Valeant Pharmaceuticals International, Inc.:
|
HIV AIDS Diarrhea HIV Associated Diarrhea |
Additional relevant MeSH terms:
|
Diarrhea Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on September 30, 2016