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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diarrhea; HIV Infections
Intervention: Octreotide (Drug)
Phase: N/A
Status: Completed
Sponsored by: Sandoz Pharmaceuticals
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.
Clinical Details
Official title: 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
Study design: Treatment, Safety Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
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.
Locations and Contacts
UCSD Med Ctr, San Diego, California 92103, United States
UCSF - San Francisco Gen Hosp, San Francisco, California 94110, United States
San Mateo County Gen Hosp, San Mateo, California 94403, United States
USC School of Medicine, Los Angeles, California 90033, United States
Kaiser Permanente Med Ctr, San Francisco, California 94115, 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
Boston City Hosp, Boston, Massachusetts 02118, United States
Douglas Plesko, Boston, Massachusetts 02115, 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
Einstein Med School, Bronx, New York 10461, United States
SUNY Stony Brook / Health Sciences Ctr, Stony Brook, New York 117948121, United States
Mount Sinai Med Ctr, New York, New York 10029, 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
Additional Information
Related publications: 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)
Last updated: June 23, 2005
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