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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
Est. completion date
Est. primary completion date
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


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)

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