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	Treatment or Intervention
Diarrhea HIV Infections	Drug: Octreotide

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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.

California
      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
Florida
      Med Service, Miami,  Florida,  33125,  United States
Georgia
      Emory Univ School of Medicine, Atlanta,  Georgia,  30303,  United States
Illinois
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
Maine
      Maine Med Ctr Med Clinics, Portland,  Maine,  04102,  United States
Massachusetts
      Boston City Hosp, Boston,  Massachusetts,  02118,  United States
      Douglas Plesko, Boston,  Massachusetts,  02115,  United States
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States
Missouri
      Univ of Missouri at Kansas City School of Medicine, Kansas City,  Missouri,  64108,  United States
New York
      SUNY Stony Brook / Health Sciences Ctr, Stony Brook,  New York,  117948121,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  97210,  United States
Pennsylvania
      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States
Rhode Island
      Miriam Hosp / Family Healthcare Ctr at SSTAR, Providence,  Rhode Island,  02906,  United States
Texas
      Univ TX Galveston Med Branch, Galveston,  Texas,  77550,  United States
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
Virginia
      Infectious Disease Physicians Inc, Annandale,  Virginia,  22203,  United States
Wisconsin
      Univ of Wisconsin School of Medicine, Madison,  Wisconsin,  53792,  United States

Study ID Numbers:  102B; D204
Record last reviewed:  August 1992
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002253
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08