Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00547898
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 374 participants
Conditions and interventions
Conditions
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
- Oct 2007 (Type not available)
- Primary completion
- Jan 27, 2011 (Actual)
- Completion
- Jul 11, 2011 (Actual)
- Last update posted
- Sep 3, 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 3, 2020 · Synced Oct 21, 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 public registry record, listed eligibility criteria, and available contact information for NCT00547898 live on ClinicalTrials.gov.