Clinical trial NCT00002253: 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.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
HIV Infections
Keywords: Octreotide
Diarrhea
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC School of Medicine
state: California
city: San Diego
country: United States
facility: UCSD Med Ctr
state: California
city: San Francisco
country: United States
facility: UCSF - San Francisco Gen Hosp
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Med Ctr
state: California
city: San Mateo
country: United States
facility: San Mateo County Gen Hosp
state: California
city: Miami
country: United States
facility: Med Service
state: Florida
city: Atlanta
country: United States
facility: Emory Univ School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Portland
country: United States
facility: Maine Med Ctr Med Clinics
state: Maine
city: Boston
country: United States
facility: Douglas Plesko
state: Massachusetts
city: Boston
country: United States
facility: Boston City Hosp
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hosp
state: Michigan
city: Kansas City
country: United States
facility: Univ of Missouri at Kansas City School of Medicine
state: Missouri
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook / Health Sciences Ctr
state: New York
city: Portland
country: United States
facility: Portland Veterans Adm Med Ctr / Rsch & Education Grp
state: Oregon
city: Philadelphia
country: United States
facility: Buckley Braffman Stern Med Associates
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hosp / Family Healthcare Ctr at SSTAR
state: Rhode Island
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
city: Madison
country: United States
facility: Univ of Wisconsin School of Medicine
state: Wisconsin
Study officials:
References: