search
Back to results

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

Primary Purpose

Diarrhea, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Crofelemer
Sponsored by
Shaman Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring Diarrhea, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hill Top Research Ltd
  • Phoenix Living Ctr
  • UCLA Care Ctr
  • AIDS Research Ctr / Dept of Veterans Affairs
  • San Francisco Gen Hosp
  • Lynn House Hospice
  • AIDS Research Alliance
  • Howard Univ
  • GCRC
  • Community CRI of South Florida
  • Central Florida Research Initiative
  • Deering Hosp
  • Rosemont Health Care Ctr
  • Ctr for Quality Care
  • Mem Hosp of Tampa
  • Phillip Branchman
  • Insite Clinical Trials
  • Oak Park Hosp
  • Indiana Univ Med Ctr
  • New Orleans Pharmaceutical Research
  • Johns Hopkins Hosp
  • New England Med Ctr
  • Wayne State Univ
  • Hennepin County Med Ctr
  • Regions Hosp
  • Washington Univ School of Medicine
  • Brookdale Univ Hosp and Med Ctr
  • Saint Vincents Hosp
  • Wake Med CRI
  • Joseph Gathe
  • GCRC - VA Hosp
  • South Texas Veterans Health Care System
  • Bailey Boushay House
  • Rosehedge House
  • Hosp Regional de Ponce
  • Clinical Research Puerto Rico Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Shaman Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00002408
Brief 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
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

2. Study Status

Record Verification Date
April 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Shaman Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, HIV Infections
Keywords
Diarrhea, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Crofelemer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hill Top Research Ltd
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Phoenix Living Ctr
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
UCLA Care Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
AIDS Research Ctr / Dept of Veterans Affairs
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Lynn House Hospice
City
West Hollywood
State/Province
California
ZIP/Postal Code
90046
Country
United States
Facility Name
AIDS Research Alliance
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Howard Univ
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
Facility Name
GCRC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Community CRI of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Central Florida Research Initiative
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Deering Hosp
City
Miami
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Rosemont Health Care Ctr
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Ctr for Quality Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Mem Hosp of Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Phillip Branchman
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Insite Clinical Trials
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Oak Park Hosp
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States
Facility Name
Indiana Univ Med Ctr
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
New Orleans Pharmaceutical Research
City
Kenner
State/Province
Louisiana
ZIP/Postal Code
70062
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212875554
Country
United States
Facility Name
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Wayne State Univ
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hennepin County Med Ctr
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Regions Hosp
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Washington Univ School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Brookdale Univ Hosp and Med Ctr
City
Brooklyn
State/Province
New York
ZIP/Postal Code
112123198
Country
United States
Facility Name
Saint Vincents Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Wake Med CRI
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Joseph Gathe
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
GCRC - VA Hosp
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
South Texas Veterans Health Care System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Bailey Boushay House
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Rosehedge House
City
Seattle
State/Province
Washington
ZIP/Postal Code
98125
Country
United States
Facility Name
Hosp Regional de Ponce
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico Inc
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs