A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea
NCT ID: NCT00002252
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Octreotide
Eligibility Criteria
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Inclusion Criteria
* Uncontrolled diarrhea that is either a manifestation or complication of documented HIV infection.
* Ability to communicate, participate, and comply with the requirements of the study.
* Capability of self administering injections of study medication or have responsible family member or companion who can.
* Given written consent prior to study entry.
Prior Medication:
Required:
* At least two weeks of conventional dosing regimens of antidiarrheal medication (e.g.:
* Lomotil, Imodium, Paregoric) within one month prior to study entry. OR Patients with evidence of upper or lower GI infection(s) for which there is approved, potentially curative therapy must have failed appropriate treatment for at least two weeks.
Exclusion Criteria
Patients with the following conditions or symptoms are excluded:
* Evidence of underlying immunosuppressive disease other than due to HIV.
* Diarrhea caused by a known gastrointestinal disorder such as idiopathic ulcerative colitis, Crohn's disease, acute stool culture positive bacterial colitis (documented within the last 2 weeks prior to study entry AND not having at least 2 weeks of antibiotic therapy), pseudomembranous colitis (Clostridium difficile toxin positive), short gut syndrome, chronic pancreatitis (alcoholic or idiopathic), ischemic bowel disease, or enteroenteric fistulae.
Patients with the following are excluded:
* Diarrhea that can be controlled with conventional antidiarrheal agents.
* Stool weight at either of the 2 baseline periods that average \< 500 g/day.
* Evidence of underlying immunosuppressive disease other than due to HIV.
* Diarrhea caused by other gastrointestinal disorders not related to HIV.
Prior Medication:
Excluded:
* Previously treated with Sandostatin as an anti-diarrheal agent.
* Experimental antidiarrheal drugs within one month of study entry.
Present intravenous drug abuse.
18 Years
ALL
No
Sponsors
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Sandoz
INDUSTRY
Locations
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USC School of Medicine
Los Angeles, California, United States
UCSD Med Ctr
San Diego, California, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, United States
Kaiser Permanente Med Ctr
San Francisco, California, United States
San Mateo County Gen Hosp
San Mateo, 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
Henry Ford Hosp
Detroit, Michigan, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States
Mount Sinai Med Ctr
New York, New York, United States
SUNY Stony Brook / Health Sciences Ctr
Stony Brook, New York, United States
Einstein Med School
The Bronx, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Miriam Hosp / Family Healthcare Ctr at SSTAR
Providence, Rhode Island, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Infectious Disease Physicians Inc
Annandale, Virginia, United States
Univ of Wisconsin School of Medicine
Madison, Wisconsin, United States
Countries
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References
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Romeu J, Miro JM, Mallolas J, Sirera G, Tortosa F, Clotet B. Sandostatin (SMS-201-995) in the long-term management of chronic diarrhea in AIDS patients. Int Conf AIDS. 1991 Jun 16-21;7(2):272 (abstract no WB2362)
Other Identifiers
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D203
Identifier Type: -
Identifier Source: secondary_id
102A
Identifier Type: -
Identifier Source: org_study_id