Clinical trial NCT00002252: 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
Official title: 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
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: 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.


Eligibility 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.

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: Bronx
country: United States
facility: Einstein Med School
state: New York
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:
citation: Romeu J, Miro JM, Mallolas J, Sirera G, Tortosa F, Clotet B. Sandostatin (SMS-201-995) in the long-term management of chronic diarrhea in AIDS patients. Int Conf AIDS. 1991 Jun 16-21;7(2):272 (abstract no WB2362)