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:
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
  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.


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:

  Eligibility

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002252

  Show 23 Study Locations
Sponsors and Collaborators
Sandoz Inc.
  More Information

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 April 21, 2014