HIV Infections Clinical Trial
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
| NCT number | NCT00002408 |
| Other study ID # | 293A |
| Secondary ID | 37,554-210 |
| Status | Completed |
| Phase | Phase 3 |
| First received | November 2, 1999 |
| Last updated | June 23, 2005 |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria Patients must have: - HIV infection meeting CDC criteria for AIDS. - History of diarrhea for greater than or equal to 14 days prior to screening period (Day 1). Required: - On stable medical regimen. |
Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Hosp Regional de Ponce | Ponce | |
| Puerto Rico | Clinical Research Puerto Rico Inc | San Juan | |
| United States | Phillip Branchman | Atlanta | Georgia |
| United States | Johns Hopkins Hosp | Baltimore | Maryland |
| United States | New England Med Ctr | Boston | Massachusetts |
| United States | Brookdale Univ Hosp and Med Ctr | Brooklyn | New York |
| United States | Community CRI of South Florida | Coral Gables | Florida |
| United States | Insite Clinical Trials | Decatur | Georgia |
| United States | Wayne State Univ | Detroit | Michigan |
| United States | Joseph Gathe | Houston | Texas |
| United States | Indiana Univ Med Ctr | Indianapolis | Indiana |
| United States | New Orleans Pharmaceutical Research | Kenner | Louisiana |
| United States | UCLA Care Ctr | Los Angeles | California |
| United States | Central Florida Research Initiative | Maitland | Florida |
| United States | Deering Hosp | Miami | Florida |
| United States | Hennepin County Med Ctr | Minneapolis | Minnesota |
| United States | Saint Vincents Hosp | New York | New York |
| United States | Oak Park Hosp | Oak Park | Illinois |
| United States | Rosemont Health Care Ctr | Orlando | Florida |
| United States | AIDS Research Ctr / Dept of Veterans Affairs | Palo Alto | California |
| United States | Wake Med CRI | Raleigh | North Carolina |
| United States | GCRC - VA Hosp | San Antonio | Texas |
| United States | South Texas Veterans Health Care System | San Antonio | Texas |
| United States | San Francisco Gen Hosp | San Francisco | California |
| United States | Hill Top Research Ltd | Scottsdale | Arizona |
| United States | Phoenix Living Ctr | Scottsdale | Arizona |
| United States | Bailey Boushay House | Seattle | Washington |
| United States | Rosehedge House | Seattle | Washington |
| United States | Washington Univ School of Medicine | St. Louis | Missouri |
| United States | Regions Hosp | St. Paul | Minnesota |
| United States | Ctr for Quality Care | Tampa | Florida |
| United States | Mem Hosp of Tampa | Tampa | Florida |
| United States | GCRC | Washington | District of Columbia |
| United States | Howard Univ | Washington | District of Columbia |
| United States | AIDS Research Alliance | West Hollywood | California |
| United States | Lynn House Hospice | West Hollywood | California |
| Lead Sponsor | Collaborator |
|---|---|
| Shaman Pharmaceuticals |
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