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

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.

• Diarrhea
• HIV Infections

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.