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

Completed · Phase 3

Conditions studied: Diarrhea, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002408

Run by

Shaman Pharmaceuticals

People needed

300

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Hill Top Research Ltd — Scottsdale, Arizona, United States
• Phoenix Living Ctr — Scottsdale, Arizona, United States
• UCLA Care Ctr — Los Angeles, California, United States
• AIDS Research Ctr / Dept of Veterans Affairs — Palo Alto, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Lynn House Hospice — West Hollywood, California, United States
• AIDS Research Alliance — West Hollywood, California, United States
• Howard Univ — Washington D.C., District of Columbia, United States
• GCRC — Washington D.C., District of Columbia, United States
• Community CRI of South Florida — Coral Gables, Florida, United States
• Central Florida Research Initiative — Maitland, Florida, United States
• Deering Hosp — Miami, Florida, United States
• Rosemont Health Care Ctr — Orlando, Florida, United States
• Ctr for Quality Care — Tampa, Florida, United States
• Mem Hosp of Tampa — Tampa, Florida, United States
• Phillip Branchman — Atlanta, Georgia, United States
• Insite Clinical Trials — Decatur, Georgia, United States
• Oak Park Hosp — Oak Park, Illinois, United States
• Indiana Univ Med Ctr — Indianapolis, Indiana, United States
• New Orleans Pharmaceutical Research — Kenner, Louisiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• New England Med Ctr — Boston, Massachusetts, United States
• Wayne State Univ — Detroit, Michigan, United States
• Hennepin County Med Ctr — Minneapolis, Minnesota, United States
• Regions Hosp — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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