Maraviroc Efficacy for Hepatitis C (MAVERIC)

April 24, 2024 updated by: Lydia Tang, University of Maryland, Baltimore

A Pilot Study to Evaluate Anti-Hepatitis C Virus Effect of Maraviroc in Patients Co-infected With Human Immunodeficiency Virus (HIV) and Hepatitis C

This is a single-site, longitudinal, open-label, interventional study for evaluating the effect of maraviroc on hepatitis C viral levels in patients infected with both hepatitis C and human immunodeficiency virus (HIV) and taking antiretroviral therapy for HIV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recently, in-vitro studies (experiments performed in a laboratory, not on a person) have demonstrated that maraviroc, a medication that is used in human immunodeficiency (HIV) therapy, appears to have significant hepatitis C antiviral effect, comparable to sofosbuvir-a potent anti-hepatitis C medication. In this study, the investigators will evaluate the antiviral effect of maraviroc on hepatitis C virus in people infected with both hepatitis C and HIV, and whom have never been treated for hepatitis with direct antiviral agents. Participants will take maraviroc for 4 weeks in addition to their regular HIV antiretrovirals (ART). The investigators will measure the hepatitis C viral load before, during, and after the 4-week maraviroc time.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Institute of Human Virology at the University of Maryland School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18 years old
  2. Hepatitis C-infected without plans to undergo hepatitis C treatment for duration of the study
  3. Human immunodeficiency virus (HIV) infected

  4. Currently receiving anti-retroviral therapy with HIV viral load <50 IU/ml for ≥ 12 months

    a. One virologic blip ≤ 400 copies/ml permissible within the 12 months

  5. CD4 T cell counts > 100 cells/mm3
  6. Non-cirrhotics and cirrhotics can be included
  7. Willing to sign informed consent

Exclusion Criteria:

  1. Age < 18
  2. Unable to comply with study visits, research study visits, or is planning to relocate during the study.
  3. Have any condition that the investigator considers a contraindication to study participation
  4. Pregnancy or breast feeding
  5. Decompensated liver disease (Child-Pugh C)
  6. Imminent treatment for hepatitis C infection
  7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal

  8. Concomitant use of drugs known to impact or be impacted in terms of pharmacokinetics or drug-drug interactions with either raltegravir, dolutegravir, or maraviroc. This includes:

    • Inducers of UGT1A1 (such as rifampin, phenytoin, phenobarbital rifabutin, St. John's wort)
    • Cytochrome P3A inhibitors (such as ketoconazole, itraconazole, clarithromycin, nefazodone, and telithromycin)
    • Cytochrome P3A inducers (such as rifampin, carbamazepine, phenobarbital and phenytoin)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate start maraviroc
To start maraviroc immediately after randomization.
Drug: Maraviroc
Participants will receive 4 weeks of maraviroc (dosing based on concomitant HIV antiretroviral regimen). Serial measurements of HCV viral load will be obtained before, during, and after maraviroc exposure. Study duration will be approximately 12 to 16 weeks.
Other Names:
  • Selzentry
Active Comparator: Delayed start maraviroc
To start maraviroc 8 weeks after enrollment.
Drug: Maraviroc
Participants will receive 4 weeks of maraviroc (dosing based on concomitant HIV antiretroviral regimen). Serial measurements of HCV viral load will be obtained before, during, and after maraviroc exposure. Study duration will be approximately 12 to 16 weeks.
Other Names:
  • Selzentry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc
Time Frame: Baseline to 4 weeks
Hepatitis C viral load was measured before starting maraviroc, and at 4 weeks of maraviroc.
Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc
Time Frame: 7 days
HCV viral load was measured before starting and at 7 days of maraviroc. Among participants that received Maraviroc in the first 4 weeks, HCV viral load was measured before first dose at day 0 and at day 7. Among participants that received Maraviroc in week 8 to 12, HCV viral load measured at day 56 before taking the first dose of Maraviroc and at day 63 (week 9) of study.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

ViiV Healthcare

Investigators

  • Principal Investigator: Lyida Tang, MBChB, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

March 27, 2019

Study Completion (Actual)

March 27, 2019

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimated)

August 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00070324

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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