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
This study has been completed.
Sponsor:
Sandoz Inc.
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002252
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1992
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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.
Condition | Intervention |
---|---|
Diarrhea HIV Infections |
Drug: Octreotide |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
![](https://webarchive.library.unt.edu/web/20130309094520im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002252
Show 23 Study Locations
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Sponsors and Collaborators
Sandoz Inc.
![](https://webarchive.library.unt.edu/web/20130309094520im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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)
ClinicalTrials.gov Identifier: | NCT00002252 History of Changes |
Other Study ID Numbers: | 102A, D203 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Octreotide Diarrhea Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Diarrhea Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immune System Diseases Slow Virus Diseases Signs and Symptoms, Digestive Signs and Symptoms Octreotide Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on March 07, 2013