Phase 3
N=250
Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea
HIV Enteropathy · Diarrhea With HIV
Bottom Line
View on ClinicalTrials.gov: NCT01374490 ↗Enrolled (actual)
250
Serious AEs
8.0%
Results posted
Aug 2020
Primary outcome: Primary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). — 189; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Crofelemer (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). |
189; 20 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01374490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.