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| Sponsor: | Shaman Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002408 |
Purpose
To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Diarrhea HIV Infections |
Drug: Crofelemer |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Required:
- On stable medical regimen.
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Hill Top Research Ltd | |
| Scottsdale, Arizona, United States, 85251 | |
| Phoenix Living Ctr | |
| Scottsdale, Arizona, United States, 85251 | |
| United States, California | |
| AIDS Research Alliance | |
| West Hollywood, California, United States, 90069 | |
| Lynn House Hospice | |
| West Hollywood, California, United States, 90046 | |
| AIDS Research Ctr / Dept of Veterans Affairs | |
| Palo Alto, California, United States, 94304 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| UCLA Care Ctr | |
| Los Angeles, California, United States, 90095 | |
| United States, District of Columbia | |
| Howard Univ | |
| Washington, District of Columbia, United States, 20059 | |
| GCRC | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| Central Florida Research Initiative | |
| Maitland, Florida, United States, 32751 | |
| Rosemont Health Care Ctr | |
| Orlando, Florida, United States, 32808 | |
| Ctr for Quality Care | |
| Tampa, Florida, United States, 33609 | |
| Mem Hosp of Tampa | |
| Tampa, Florida, United States, 33609 | |
| Community CRI of South Florida | |
| Coral Gables, Florida, United States, 33146 | |
| Deering Hosp | |
| Miami, Florida, United States, 33157 | |
| United States, Georgia | |
| Insite Clinical Trials | |
| Decatur, Georgia, United States, 30033 | |
| Phillip Branchman | |
| Atlanta, Georgia, United States, 30327 | |
| United States, Illinois | |
| Oak Park Hosp | |
| Oak Park, Illinois, United States, 60304 | |
| United States, Indiana | |
| Indiana Univ Med Ctr | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Louisiana | |
| New Orleans Pharmaceutical Research | |
| Kenner, Louisiana, United States, 70062 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 212875554 | |
| United States, Massachusetts | |
| New England Med Ctr | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Wayne State Univ | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Regions Hosp | |
| St. Paul, Minnesota, United States, 55101 | |
| Hennepin County Med Ctr | |
| Minneapolis, Minnesota, United States, 55415 | |
| United States, Missouri | |
| Washington Univ School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Brookdale Univ Hosp and Med Ctr | |
| Brooklyn, New York, United States, 112123198 | |
| Saint Vincents Hosp | |
| New York, New York, United States, 10011 | |
| United States, North Carolina | |
| Wake Med CRI | |
| Raleigh, North Carolina, United States, 27610 | |
| United States, Texas | |
| South Texas Veterans Health Care System | |
| San Antonio, Texas, United States, 78284 | |
| GCRC - VA Hosp | |
| San Antonio, Texas, United States, 78284 | |
| Joseph Gathe | |
| Houston, Texas, United States, 77004 | |
| United States, Washington | |
| Bailey Boushay House | |
| Seattle, Washington, United States, 98112 | |
| Rosehedge House | |
| Seattle, Washington, United States, 98125 | |
| Puerto Rico | |
| Clinical Research Puerto Rico Inc | |
| San Juan, Puerto Rico, 00909 | |
| Hosp Regional de Ponce | |
| Ponce, Puerto Rico, 00731 | |
More Information
| Study ID Numbers: | 293A, 37,554-210 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002408 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Diarrhea Acquired Immunodeficiency Syndrome |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Disease Slow Virus Diseases Diarrhea Signs and Symptoms, Digestive Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases Signs and Symptoms Pathologic Processes HIV Infections Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
