Expired Study
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Boston, Massachusetts 02118


Purpose:

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.


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.


Study is Available At:


Original ID:

102A


NCT ID:

NCT00002252


Secondary ID:

D203


Study Acronym:


Brief Title:

A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients Wi


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Primary Pu


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:August 1992
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Octreotide

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sandoz Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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)

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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