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NCT Number: NCT02881762

Maraviroc Efficacy for 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.

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Key information

Conditions

Hepatitis C Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis, Viral, Human Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Human Virology at the University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

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

Treatment and study plan

Maraviroc

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • ViiV Healthcare

Registry information

Official study title

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

Acronym: MAVERIC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2016
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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