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

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ClinicalTrials.gov Identifier: NCT00547898
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
HIV Associated Diarrhea Drug: Crofelemer 125 mg Drug: Crofelemer 250 mg Drug: Crofelemer 500 mg Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea HIV/AIDS
Drug Information available for: Crofelemer

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547898


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Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
More Information
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Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00547898     History of Changes
Other Study ID Numbers: NP303-101
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

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