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Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea

NCT04192487 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-10-22

No results posted yet for this study

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.

Conditions

  • Acquired Immunodeficiency Syndrome
  • Healthy Volunteers
  • HIV/AIDS
  • HIV Diarrhea
  • Human Immunodeficiency Virus

Interventions

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.

Sponsors & Collaborators

  • Napo Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Smith, MD · Integrium Clinical Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-22
Primary Completion
2021-08-31
Completion
2021-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04192487 on ClinicalTrials.gov