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

Completed · Not applicable

Conditions studied: Diarrhea, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002252

Run by

Sandoz

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 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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