NCT00547898View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

374

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

January 27, 2011

Study Completion Date

July 11, 2011

Conditions
HIV Associated Diarrhea
Interventions
DRUG

Crofelemer 125 mg

Crofelemer 125 mg

DRUG

Crofelemer 250 mg

Crofelemer 250 mg

DRUG

Crofelemer 500 mg

Crofelemer 500 mg

DRUG

Placebo

Placebo

Trial Locations (82)

10010

New York

10011

New York

10018

New York

10461

The Bronx

10550

Mount Vernon

11023

Great Neck

11030

Manhasset

14604

Rochester

21201

Baltimore

23219

Richmond

24501

Lynchburg

28504

Gastonia

29203

Columbia

30309

Atlanta

30318

Atlanta

32117

Daytona Beach

32803

Orlando

32806

Orlando

33133

Miami

33137

Miami

33139

Miami Beach

33180

Miami

33305

Wilton Manors

33306

Fort Lauderdale

33308

Fort Lauderdale

33316

Fort Lauderdale

33401

West Palm Beach

33602

Tampa

33614

Tampa

34982

Ft. Pierce

35801

Huntsville

45267

Cincinnati

48109

Ann Arbor

48201

Detroit

48202

Detroit

52242

Iowa City

60607

Chicago

60611

Chicago

60654

Chicago

63108

St Louis

64106

Kansas City

64111

Kansas City

72207

Little Rock

75243

Dallas

75246

Dallas

75605

Longview

77004

Houston

77030

Dallas

Houston

77074

Houston

77098

Houston

77401

Bellaire

78229

San Antonio

78258

San Antonio

78550

Harlingen

78705

Austin

80205

Denver

85006

Phoenix

87131

Albuquerque

87505

Santa Fe

90015

Los Angeles

90022

Los Angeles

90027

Los Angeles

90210

Beverly Hills

90211

Beverly Hills

90813

Long Beach

92120

San Diego

92262

Palm Springs

92708

Fountain Valley

93301

Bakersfield

94118

San Francisco

94403

San Mateo

94609

Oakland

97210

Portland

97219

Portland

98104

Seattle

99204

Spokane

02111

Boston

01107

Springfield

00717

Ponce

00935

Rio Piedras

00909

San Juan

All Listed Sponsors
lead

Bausch Health Americas, Inc.

INDUSTRY

NCT00547898 - Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea | Biotech Hunter | Biotech Hunter