Trials / Completed
CompletedNCT04192487
Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea
A Phase 4 Open Label Study to Assess the Safety and Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in People Living With HIV/AIDS (PLWHA) With Non-Infectious Diarrhea
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Napo Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study is intended to evaluate: 1. Any changes in the gut microbiome from baseline compared to end of study in both healthy (HIV-negative) subjects and HIV+ patients with or without chronic diarrhea, following one month of treatment with crofelemer (Mytesi), delayed release 125 mg tablets twice daily (BID) following one month of treatment. 2. The safety and tolerability of crofelemer, (Mytesi) delayed release 125 mg tablets BID in healthy (HIV-negative) volunteers and HIV+ patients following one month of treatment.
Detailed description
Mytesi ®(crofelemer) is an FDA-approved anti-diarrheal drug indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on combination anti-retroviral therapy (CART). Crofelemer, a first-in-class intraluminally active, use-dependent chloride (Cl-) ion channel modulator that produces an antidiarrheal effect by reducing Cl- secretion and the accompanying high-volume fluid secretion into the GI lumen. This Phase 4 trial will explore the induced gut microbiome changes in comparison to a group of normal healthy volunteers also receiving crofelemer delayed release 125 mg tablets twice daily for 30 days. This is a non-randomized study. The study will enroll approximately 24 male or female subjects aged at least 18 years in three cohorts of approximately 8 subjects each.
Conditions
- Acquired Immunodeficiency Syndrome
- Healthy Volunteers
- HIV/AIDS
- HIV Diarrhea
- Human Immunodeficiency Virus
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Crofelemer delayed-release tablets 125mg | 1 crofelemer delayed-release tablet twice daily at least 8 hours apart for 30 days with or without meals. |
Timeline
- Start date
- 2019-10-22
- Primary completion
- 2021-08-31
- Completion
- 2021-08-31
- First posted
- 2019-12-10
- Last updated
- 2021-10-22
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04192487. Inclusion in this directory is not an endorsement.