Clinical trial NCT00002408: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea
HIV Infections
Keywords: Diarrhea
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment.


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV infection meeting CDC criteria for AIDS.
* History of diarrhea for greater than or equal to 14 days prior to screening period (Day 1).

Required:

- On stable medical regimen.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Hill Top Research Ltd
state: Arizona
city: Scottsdale
country: United States
facility: Phoenix Living Ctr
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Care Ctr
state: California
city: Palo Alto
country: United States
facility: AIDS Research Ctr / Dept of Veterans Affairs
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: West Hollywood
country: United States
facility: Lynn House Hospice
state: California
city: West Hollywood
country: United States
facility: AIDS Research Alliance
state: California
city: Washington
country: United States
facility: Howard Univ
state: District of Columbia
city: Washington
country: United States
facility: GCRC
state: District of Columbia
city: Coral Gables
country: United States
facility: Community CRI of South Florida
state: Florida
city: Maitland
country: United States
facility: Central Florida Research Initiative
state: Florida
city: Miami
country: United States
facility: Deering Hosp
state: Florida
city: Orlando
country: United States
facility: Rosemont Health Care Ctr
state: Florida
city: Tampa
country: United States
facility: Ctr for Quality Care
state: Florida
city: Tampa
country: United States
facility: Mem Hosp of Tampa
state: Florida
city: Atlanta
country: United States
facility: Phillip Branchman
state: Georgia
city: Decatur
country: United States
facility: Insite Clinical Trials
state: Georgia
city: Oak Park
country: United States
facility: Oak Park Hosp
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Med Ctr
state: Indiana
city: Kenner
country: United States
facility: New Orleans Pharmaceutical Research
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Boston
country: United States
facility: New England Med Ctr
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State Univ
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Med Ctr
state: Minnesota
city: St. Paul
country: United States
facility: Regions Hosp
state: Minnesota
city: St. Louis
country: United States
facility: Washington Univ School of Medicine
state: Missouri
city: Brooklyn
country: United States
facility: Brookdale Univ Hosp and Med Ctr
state: New York
city: New York
country: United States
facility: Saint Vincents Hosp
state: New York
city: Raleigh
country: United States
facility: Wake Med CRI
state: North Carolina
city: Houston
country: United States
facility: Joseph Gathe
state: Texas
city: San Antonio
country: United States
facility: GCRC - VA Hosp
state: Texas
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System
state: Texas
city: Seattle
country: United States
facility: Bailey Boushay House
state: Washington
city: Seattle
country: United States
facility: Rosehedge House
state: Washington
city: Ponce
country: Puerto Rico
facility: Hosp Regional de Ponce
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico Inc
Study officials:
References: