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

October 21, 2007
December 22, 2011
October 2007
Not Provided
  • 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 ]
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 ]
Complete list of historical versions of study NCT00547898 on ClinicalTrials.gov Archive Site
Not Provided
To evaluate the effects of crofelemer vs. placebo on: • Number of bowel movements per day • Number of watery bowel movements per day • Symptom frequency • Symptom severity • Daily stool consistency score • Safety and tolerability of [ Time Frame: 6 months ]
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Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Associated Diarrhea
  • Drug: Crofelemer 125 mg
    Crofelemer 125 mg
  • Drug: Crofelemer 250 mg
    Crofelemer 250 mg
  • Drug: Crofelemer 500 mg
    Crofelemer 500 mg
  • Drug: Placebo
    Placebo
  • Experimental: Placebo
    Intervention: Drug: Placebo
  • Experimental: Crofelemer 125 mg
    Intervention: Drug: Crofelemer 125 mg
  • Experimental: Crofelemer 250 mg
    Intervention: Drug: Crofelemer 250 mg
  • Experimental: Crofelemer 500 mg
    Intervention: Drug: Crofelemer 500 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
Not Provided
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00547898
NP303-101
Yes
Salix Pharmaceuticals
Salix Pharmaceuticals
Not Provided
Not Provided
Salix Pharmaceuticals
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP