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
2 other identifiers
interventional
N/A
1 country
23
Brief Summary
To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in controlling diarrhea which is a manifestation or complication of documented HIV infection and which is refractory (does not respond) to all known treatment classes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 1992
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have the following:
- 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.
You may not qualify if:
- Co-existing Condition:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
Study Sites (23)
USC School of Medicine
Los Angeles, California, 90033, United States
UCSD Med Ctr
San Diego, California, 92103, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
San Mateo County Gen Hosp
San Mateo, California, 94403, United States
Med Service
Miami, Florida, 33125, United States
Emory Univ School of Medicine
Atlanta, Georgia, 30303, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Maine Med Ctr Med Clinics
Portland, Maine, 04102, United States
Douglas Plesko
Boston, Massachusetts, 02115, United States
Boston City Hosp
Boston, Massachusetts, 02118, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
SUNY Stony Brook / Health Sciences Ctr
Stony Brook, New York, 117948121, United States
Einstein Med School
The Bronx, New York, 10461, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Miriam Hosp / Family Healthcare Ctr at SSTAR
Providence, Rhode Island, 02906, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
Univ of Wisconsin School of Medicine
Madison, Wisconsin, 53792, United States
Related Publications (1)
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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1992-08