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
  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 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

  Hide Study Locations
Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Phoenix, Arizona, United States, 85006
United States, Arkansas
Little Rock, Arkansas, United States, 72207
United States, California
Bakersfield, California, United States, 93301
Beverly Hills, California, United States, 90211
Beverly Hills, California, United States, 90210
Fountain Valley, California, United States, 92708
Long Beach, California, United States, 90813
Los Angeles, California, United States, 90015
Los Angeles, California, United States, 90022
Los Angeles, California, United States, 90027
Oakland, California, United States, 94609
Palm Springs, California, United States, 92262
San Diego, California, United States, 92120
San Francisco, California, United States, 94118
San Mateo, California, United States, 94403
United States, Colorado
Denver, Colorado, United States, 80205
United States, Florida
Daytona Beach, Florida, United States, 32117
Fort Lauderdale, Florida, United States, 33306
Fort Lauderdale, Florida, United States, 33308
Fort Lauderdale, Florida, United States, 33316
Fort Pierce, Florida, United States, 34982
Ft. Lauderdale, Florida, United States, 33308
Miami, Florida, United States, 33133
Miami, Florida, United States, 33137
Miami, Florida, United States, 33180
Miami Beach, Florida, United States, 33139
Orlando, Florida, United States, 32803
Orlando, Florida, United States, 32806
Tampa, Florida, United States, 33602
Tampa, Florida, United States, 33614
W. Palm Beach, Florida, United States, 33401
Wilton Manors, Florida, United States, 33305
United States, Georgia
Atlanta, Georgia, United States, 30309
Atlanta, Georgia, United States, 30318
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60654
Chicago, Illinois, United States, 60607
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Springfield, Massachusetts, United States, 01107
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48201
Detroit, Michigan, United States, 48202
United States, Missouri
Kansas City, Missouri, United States, 64106
Kansas City, Missouri, United States, 64111
St. Louis, Missouri, United States, 63108
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
Santa Fe, New Mexico, United States, 87505
United States, New York
Bronx, New York, United States, 10461
Great Neck, New York, United States, 11023
Manhasset, New York, United States, 11030
Mount Vernon, New York, United States, 10550
New York, New York, United States, 10018
New York, New York, United States, 10010
New York, New York, United States, 10011
Rochester, New York, United States, 14604
United States, North Carolina
Gastonia, North Carolina, United States, 28504
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Oregon
Portland, Oregon, United States, 97219
Portland, Oregon, United States, 97210
United States, South Carolina
Columbia, South Carolina, United States, 29203
United States, Texas
Austin, Texas, United States, 78705
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 77030
Dallas, Texas, United States, 75246
Dallas, Texas, United States, 75243
Harlingen, Texas, United States, 78550
Houston, Texas, United States, 77030
Houston, Texas, United States, 77004
Houston, Texas, United States, 77074
Houston, Texas, United States, 77098
Longview, Texas, United States, 75605
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78258
United States, Virginia
Lynchburg, Virginia, United States, 24501
Richmond, Virginia, United States, 23219
United States, Washington
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99204
Puerto Rico
Ponce, Puerto Rico, 00717
Rio Piedras, Puerto Rico, 00935
San Juan, Puerto Rico, 00909
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 April 15, 2014