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Maraviroc Efficacy for Hepatitis C (MAVERIC)

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status and phase

Completed
Phase 4

Conditions

Human Immunodeficiency Virus
Hepatitis C

Treatments

Drug: Maraviroc

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02881762
HP-00070324

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Immediate start maraviroc
Active Comparator group
Description:
To start maraviroc immediately after randomization.
Treatment:
Drug: Maraviroc
Delayed start maraviroc
Active Comparator group
Description:
To start maraviroc 8 weeks after enrollment.
Treatment:
Drug: Maraviroc

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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