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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, California
USC School of Medicine
Los Angeles, California, United States, 90033
UCSD Med Ctr
San Diego, California, United States, 92103
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
San Mateo County Gen Hosp
San Mateo, California, United States, 94403
United States, Florida
Med Service
Miami, Florida, United States, 33125
United States, Georgia
Emory Univ School of Medicine
Atlanta, Georgia, United States, 30303
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Maine
Maine Med Ctr Med Clinics
Portland, Maine, United States, 04102
United States, Massachusetts
Boston City Hosp
Boston, Massachusetts, United States, 02118
Douglas Plesko
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, Missouri
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
United States, New York
Einstein Med School
Bronx, New York, United States, 10461
Mount Sinai Med Ctr
New York, New York, United States, 10029
SUNY Stony Brook / Health Sciences Ctr
Stony Brook, New York, United States, 117948121
United States, Oregon
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States, 97210
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Miriam Hosp / Family Healthcare Ctr at SSTAR
Providence, Rhode Island, United States, 02906
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
United States, Wisconsin
Univ of Wisconsin School of Medicine
Madison, Wisconsin, United States, 53792
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:
Immunologic Deficiency Syndromes
HIV Infections
Acquired Immunodeficiency Syndrome
Diarrhea
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014