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 - Full Text View

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

This study has been completed.

Sponsored by:	Shaman Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002408

Purpose

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.

Condition	Intervention	Phase
Diarrhea HIV Infections	Drug: Crofelemer	Phase III

MedlinePlus related topics:

AIDS Diarrhea

ChemIDplus related topics:

SP 303

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety Study

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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

300

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002408

Show 36 Study Locations

Sponsors and Collaborators

Shaman Pharmaceuticals

More Information

Study ID Numbers:	293A, 37,554-210
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002408
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Diarrhea

Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:

Virus Diseases

Signs and Symptoms

Sexually Transmitted Diseases, Viral

Diarrhea

Signs and Symptoms, Digestive

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Pathologic Processes

Disease

Slow Virus Diseases

Immune System Diseases

Syndrome

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on October 10, 2008