A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.
- Conditions
- DiarrheaHIV Infections
- Registration Number
- NCT00002253
- Lead Sponsor
- Sandoz
- Brief Summary
The primary objective of this study is to determine the relapse rate in patients with AIDS-related diarrhea who were found to be "Responders" in a previous placebo-controlled, double-blind study of Sandostatin (Study #D203 - FDA 102A).
The secondary objectives include: 1) To evaluate clinical efficacy and safety of open-label Sandostatin in patients who were "Non-Responders" in Study #D203 - FDA 102A; 2) To evaluate the efficacy and safety of Sandostatin during prolonged open-label treatment in "Responders" from Study #D03 - FDA 102A.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
USC School of Medicine
🇺🇸Los Angeles, California, United States
Med Service
🇺🇸Miami, Florida, United States
Emory Univ School of Medicine
🇺🇸Atlanta, Georgia, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Maine Med Ctr Med Clinics
🇺🇸Portland, Maine, United States
Douglas Plesko
🇺🇸Boston, Massachusetts, United States
Boston City Hosp
🇺🇸Boston, Massachusetts, United States
SUNY Stony Brook / Health Sciences Ctr
🇺🇸Stony Brook, New York, United States
Buckley Braffman Stern Med Associates
🇺🇸Philadelphia, Pennsylvania, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
UCSD Med Ctr
🇺🇸San Diego, California, United States
San Mateo County Gen Hosp
🇺🇸San Mateo, California, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Miriam Hosp / Family Healthcare Ctr at SSTAR
🇺🇸Providence, Rhode Island, United States
Infectious Disease Physicians Inc
🇺🇸Annandale, Virginia, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
🇺🇸Portland, Oregon, United States
Univ of Wisconsin School of Medicine
🇺🇸Madison, Wisconsin, United States
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Univ of Missouri at Kansas City School of Medicine
🇺🇸Kansas City, Missouri, United States