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	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:

• 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.

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
      Einstein Med School, Bronx,  New York,  10461,  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
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:  102A; D203
Record last reviewed:  August 1992
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002252
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08