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.

Condition(s) targeted: Diarrhea; HIV Infections

Intervention: Octreotide (Drug)

Phase: N/A

Status: Completed

Sponsored by: Sandoz Pharmaceuticals

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.

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.

Study design: Treatment, Double-Blind, Safety Study

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

UCSD Med Ctr, San Diego, California 92103, United States

UCSF - San Francisco Gen Hosp, San Francisco, California 94110, United States

San Mateo County Gen Hosp, San Mateo, California 94403, United States

USC School of Medicine, Los Angeles, California 90033, United States

Kaiser Permanente Med Ctr, San Francisco, California 94115, United States

Med Service, Miami, Florida 33125, United States

Emory Univ School of Medicine, Atlanta, Georgia 30303, United States

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States

Maine Med Ctr Med Clinics, Portland, Maine 04102, United States

Boston City Hosp, Boston, Massachusetts 02118, United States

Douglas Plesko, Boston, Massachusetts 02115, United States

Henry Ford Hosp, Detroit, Michigan 48202, United States

Univ of Missouri at Kansas City School of Medicine, Kansas City, Missouri 64108, United States

SUNY Stony Brook / Health Sciences Ctr, Stony Brook, New York 117948121, United States

Mount Sinai Med Ctr, New York, New York 10029, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 97210, United States

Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States

Miriam Hosp / Family Healthcare Ctr at SSTAR, Providence, Rhode Island 02906, United States

Univ TX Galveston Med Branch, Galveston, Texas 77550, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Infectious Disease Physicians Inc, Annandale, Virginia 22203, United States

Univ of Wisconsin School of Medicine, Madison, Wisconsin 53792, United States

Last updated: June 23, 2005