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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00547898

Public ClinicalTrials.gov record NCT00547898. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 12:48 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT00547898
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bausch Health Americas, Inc.
Industry
Enrollment
374 participants

Conditions and interventions

Interventions

  • Crofelemer 125 mg Drug
  • Crofelemer 250 mg Drug
  • Crofelemer 500 mg Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2007
Primary completion
Jan 26, 2011
Completion
Jul 10, 2011
Last update posted
Sep 2, 2020

2007 – 2011

United States locations

U.S. sites
79
U.S. states
22
U.S. cities
56
Facility City State ZIP Site status
Not listed Huntsville Alabama 35801
Not listed Phoenix Arizona 85006
Not listed Little Rock Arkansas 72207
Not listed Bakersfield California 93301
Not listed Beverly Hills California 90210
Not listed Beverly Hills California 90211
Not listed Fountain Valley California 92708
Not listed Long Beach California 90813
Not listed Los Angeles California 90015
Not listed Los Angeles California 90022
Not listed Los Angeles California 90027
Not listed Oakland California 94609
Not listed Palm Springs California 92262
Not listed San Diego California 92120
Not listed San Francisco California 94118
Not listed San Mateo California 94403
Not listed Denver Colorado 80205
Not listed Daytona Beach Florida 32117
Not listed Fort Lauderdale Florida 33306
Not listed Fort Lauderdale Florida 33308
Not listed Fort Lauderdale Florida 33316
Not listed Ft. Pierce Florida 34982
Not listed Miami Florida 33133
Not listed Miami Florida 33137
Not listed Miami Florida 33180
Not listed Miami Beach Florida 33139
Not listed Orlando Florida 32803
Not listed Orlando Florida 32806
Not listed Tampa Florida 33602
Not listed Tampa Florida 33614
Not listed West Palm Beach Florida 33401
Not listed Wilton Manors Florida 33305
Not listed Atlanta Georgia 30309
Not listed Atlanta Georgia 30318
Not listed Chicago Illinois 60607
Not listed Chicago Illinois 60611
Not listed Chicago Illinois 60654
Not listed Iowa City Iowa 52242
Not listed Baltimore Maryland 21201
Not listed Boston Massachusetts 02111
Not listed Springfield Massachusetts 01107
Not listed Ann Arbor Michigan 48109
Not listed Detroit Michigan 48201
Not listed Detroit Michigan 48202
Not listed Kansas City Missouri 64106
Not listed Kansas City Missouri 64111
Not listed St Louis Missouri 63108
Not listed Albuquerque New Mexico 87131
Not listed Santa Fe New Mexico 87505
Not listed Great Neck New York 11023
Not listed Manhasset New York 11030
Not listed Mount Vernon New York 10550
Not listed New York New York 10010
Not listed New York New York 10011
Not listed New York New York 10018
Not listed Rochester New York 14604
Not listed The Bronx New York 10461
Not listed Gastonia North Carolina 28504
Not listed Cincinnati Ohio 45267
Not listed Portland Oregon 97210
Not listed Portland Oregon 97219
Not listed Columbia South Carolina 29203
Not listed Austin Texas 78705
Not listed Bellaire Texas 77401
Not listed Dallas Texas 75243
Not listed Dallas Texas 75246
Not listed Dallas Texas 77030
Not listed Harlingen Texas 78550
Not listed Houston Texas 77004
Not listed Houston Texas 77030
Not listed Houston Texas 77074
Not listed Houston Texas 77098
Not listed Longview Texas 75605
Not listed San Antonio Texas 78229
Not listed San Antonio Texas 78258
Not listed Lynchburg Virginia 24501
Not listed Richmond Virginia 23219
Not listed Seattle Washington 98104
Not listed Spokane Washington 99204

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00547898, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 2, 2020 · Synced Jul 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00547898 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →