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.

Sandoz

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Diarrhea HIV Infections

Interventions

OctreotideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

USC School of Medicine

Los Angeles, California, United States

Data from ClinicalTrials.gov

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