Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea - Full Text View

Sponsor:	Salix Pharmaceuticals
Information provided by (Responsible Party):	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00547898

Purpose

This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.

Condition	Intervention	Phase
HIV Associated Diarrhea	Drug: Crofelemer 125 mg Drug: Crofelemer 250 mg Drug: Crofelemer 500 mg Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Two-Stage Study to Assess the Efficacy and Safety of 3 Doses of Crofelemer Orally Twice Daily for the Treatment of HIV-Associated Diarrhea

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea HIV/AIDS

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

The primary objective is to determine the proportion of HIV-positive subjects experiencing relief of diarrhea with crofelemer compared to placebo during the placebo-controlled treatment phase. [ Time Frame: 31 days ] [ Designated as safety issue: No ]
Primary efficacy outcome is two or less watery bowel movements per week during at least two weeks of the treatment phase. [ Time Frame: 31 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	October 2007

Arms	Assigned Interventions
Experimental: Placebo	Drug: Placebo Placebo
Experimental: Crofelemer 125 mg	Drug: Crofelemer 125 mg Crofelemer 125 mg
Experimental: Crofelemer 250 mg	Drug: Crofelemer 250 mg Crofelemer 250 mg
Experimental: Crofelemer 500 mg	Drug: Crofelemer 500 mg Crofelemer 500 mg

Eligibility

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

Criteria

Inclusion Criteria:

History of HIV-1 infection confirmed by standard serological tests
Stable medical regimen for treatment of HIV disease and associated conditions for at least 4 weeks prior to screening
Patient-reported history of diarrhea, defined as either persistently loose stools despite regular ADM use, or one or more watery bowel movements per day without regular ADM use, of at least 1 month duration
Colonoscopy within the past 5 years if ≥ 50 years of age.

Exclusion Criteria:

Pregnancy or breast-feeding
Current or past gastrointestinal (GI) medical or surgical conditions
Use of certain opiate pain medication within 2 weeks of screening
Use of an antibiotic within 2 weeks prior to screening, with the exception of stable antibiotic therapy for prophylactic treatment of infection or an HIV-associated condition
CD4 counts < 100 cells/mm3
Previous randomization into this study, or into any other crofelemer study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547898

Show 83 Study Locations

Sponsors and Collaborators

Salix Pharmaceuticals

More Information

No publications provided

Responsible Party:	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00547898 History of Changes
Other Study ID Numbers:	NP303-101
Study First Received:	October 21, 2007
Last Updated:	December 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:

HIV
AIDS
Diarrhea
HIV Associated Diarrhea

Additional relevant MeSH terms:

Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2012