NCT01374490

Brief Summary

This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2012

Completed
7.8 years until next milestone

Results Posted

Study results publicly available

August 17, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

1.4 years

First QC Date

June 13, 2011

Results QC Date

August 3, 2020

Last Update Submit

August 14, 2020

Conditions

HIV EnteropathyDiarrhea With HIV

Keywords

HIV +HIV positiveHIV associated diarrheaAIDSDiarrhea

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).

    48 weeks

Study Arms (1)

Crofelemer

EXPERIMENTAL
Drug: Crofelemer

Interventions

CrofelemerDRUG

Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.

Crofelemer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ≥ 18 years old
  • History of HIV-1 infection
  • On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening
  • Self-reported presence of diarrhea necessitating ADM use for at least 4 weeks

You may not qualify if:

  • CD4 counts \< 100 cells/mm3
  • Oral temperature greater than 38.0° C, or unintentional weight loss of 5.0 kg or greater during the prior 2 months
  • Bright red blood per rectum judged not to be of an anal (e.g., hemorrhoid, fissure) origin
  • Immediate need for GI surgery or intervention for active GI bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Phoenix, Arizona, 85006, United States

Location

Unknown Facility

Little Rock, Arkansas, 72207, United States

Location

Unknown Facility

Bakersfield, California, 93301, United States

Location

Unknown Facility

Beverly Hills, California, 90211, United States

Location

Unknown Facility

Los Angeles, California, 90015, United States

Location

Unknown Facility

San Diego, California, 92120, United States

Location

Unknown Facility

Fort Lauderdale, Florida, 33308, United States

Location

Unknown Facility

Fort Lauderdale, Florida, 33316, United States

Location

Unknown Facility

Miami, Florida, 33180, United States

Location

Unknown Facility

Miami Beach, Florida, 33139, United States

Location

Unknown Facility

Wilton Manors, Florida, 33305, United States

Location

Unknown Facility

Atlanta, Georgia, 30318, United States

Location

Unknown Facility

Chicago, Illinois, 60607, United States

Location

Unknown Facility

Chicago, Illinois, 60654, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

Santa Fe, New Mexico, 87505, United States

Location

Unknown Facility

New York, New York, 10018, United States

Location

Unknown Facility

Rochester, New York, 14607, United States

Location

Unknown Facility

Cincinnati, Ohio, 45267, United States

Location

Unknown Facility

Portland, Oregon, 97210, United States

Location

Unknown Facility

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

HIV EnteropathyHIV SeropositivityAcquired Immunodeficiency SyndromeDiarrhea

Interventions

crofelemer

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Bausch Health
susan.harris@bauschhealth.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2011

First Posted

June 16, 2011

Study Start

June 7, 2011

Primary Completion

October 31, 2012

Study Completion

October 31, 2012

Last Updated

August 31, 2020

Results First Posted

August 17, 2020

Record last verified: 2020-08

Locations

US(21)