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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002252
• Other study ID #: 102A
• Secondary ID: D203
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 1992
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Octreotide

Locations

Country	Name	City	State
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	Emory Univ School of Medicine	Atlanta	Georgia
United States	Boston City Hosp	Boston	Massachusetts
United States	Douglas Plesko	Boston	Massachusetts
United States	Einstein Med School	Bronx	New York
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Henry Ford Hosp	Detroit	Michigan
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Univ of Missouri at Kansas City School of Medicine	Kansas City	Missouri
United States	USC School of Medicine	Los Angeles	California
United States	Univ of Wisconsin School of Medicine	Madison	Wisconsin
United States	Med Service	Miami	Florida
United States	Mount Sinai Med Ctr	New York	New York
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Maine Med Ctr Med Clinics	Portland	Maine
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Miriam Hosp / Family Healthcare Ctr at SSTAR	Providence	Rhode Island
United States	UCSD Med Ctr	San Diego	California
United States	Kaiser Permanente Med Ctr	San Francisco	California
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	San Mateo County Gen Hosp	San Mateo	California
United States	SUNY Stony Brook / Health Sciences Ctr	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz Inc.

Country where clinical trial is conducted

United States, 

References & 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)