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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:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00547898
First received: October 21, 2007
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
  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:

MedlinePlus related topics: Diarrhea HIV/AIDS
U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547898

  Show 83 Study Locations
Sponsors and Collaborators
Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Salix Pharmaceuticals
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 Salix Pharmaceuticals:
HIV
AIDS
Diarrhea
HIV Associated Diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on March 07, 2013