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

Sponsor

Sandoz (Industry)

Overall Status

Completed

CT.gov ID

NCT00002252

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea HIV Infections	Drug: Octreotide	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC School of Medicine	Los Angeles	California	United States	90033
2	UCSD Med Ctr	San Diego	California	United States	92103
3	UCSF - San Francisco Gen Hosp	San Francisco	California	United States	94110
4	Kaiser Permanente Med Ctr	San Francisco	California	United States	94115
5	San Mateo County Gen Hosp	San Mateo	California	United States	94403
6	Med Service	Miami	Florida	United States	33125
7	Emory Univ School of Medicine	Atlanta	Georgia	United States	30303
8	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
9	Maine Med Ctr Med Clinics	Portland	Maine	United States	04102
10	Douglas Plesko	Boston	Massachusetts	United States	02115
11	Boston City Hosp	Boston	Massachusetts	United States	02118
12	Henry Ford Hosp	Detroit	Michigan	United States	48202
13	Univ of Missouri at Kansas City School of Medicine	Kansas City	Missouri	United States	64108
14	Einstein Med School	Bronx	New York	United States	10461
15	Mount Sinai Med Ctr	New York	New York	United States	10029
16	SUNY Stony Brook / Health Sciences Ctr	Stony Brook	New York	United States	117948121
17	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon	United States	97210
18	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania	United States	19107
19	Miriam Hosp / Family Healthcare Ctr at SSTAR	Providence	Rhode Island	United States	02906
20	Univ TX Galveston Med Branch	Galveston	Texas	United States	77550
21	Baylor College of Medicine	Houston	Texas	United States	77030
22	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203
23	Univ of Wisconsin School of Medicine	Madison	Wisconsin	United States	53792