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A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1992

The primary objective of this study is to determine the relapse rate in patients with AIDS-related diarrhea who were found to be "Responders" in a previous placebo-controlled, double-blind study of Sandostatin (Study #D203 - FDA 102A).

The secondary objectives include: 1) To evaluate clinical efficacy and safety of open-label Sandostatin in patients who were "Non-Responders" in Study #D203 - FDA 102A; 2) To evaluate the efficacy and safety of Sandostatin during prolonged open-label treatment in "Responders" from Study #D03 - FDA 102A.

Condition Intervention
HIV Infections
Drug: Octreotide

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study.

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients must have the following:

  • Only patients who have completed the duration of Study D203, FDA 102A will be eligible for this study.
  • Each of these patients must give written informed consent to participate in Study D204, FDA 102B as well.
  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 identifier: NCT00002253

  Hide Study Locations
United States, California
USC School of Medicine
Los Angeles, California, United States, 90033
UCSD Med Ctr
San Diego, California, United States, 92103
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
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
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

No publications provided Identifier: NCT00002253     History of Changes
Other Study ID Numbers: 102B, D204
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:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Signs and Symptoms, Digestive
Slow Virus Diseases
Virus Diseases
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2014