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Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

A Phase 3, Multicenter, Open-Label Evaluation of the Safety and Tolerability of Crofelemer in HIV-Positive Subjects With Diarrhea

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01374490
Enrollment
250
Registered
2011-06-16
Start date
2011-06-07
Completion date
2012-10-31
Last updated
2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Enteropathy, Diarrhea With HIV

Keywords

HIV +, HIV positive, HIV associated diarrhea, AIDS, Diarrhea

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.

Interventions

DRUGCrofelemer

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

Sponsors

Bausch Health Americas, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).48 weeks

Countries

United States

Participant flow

Participants by arm

ArmCount
Crofelemer
Crofelemer: Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
250
Total250

Baseline characteristics

CharacteristicCrofelemer
Age, Continuous46.8 years
STANDARD_DEVIATION 8.27
Sex: Female, Male
Female
39 Participants
Sex: Female, Male
Male
211 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
107 / 250
serious
Total, serious adverse events
20 / 250

Outcome results

Primary

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

Time frame: 48 weeks

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
CrofelemerPercentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).Any TEAE189 Participants
CrofelemerPercentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).Any SAEs20 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026