Maraviroc Efficacy for Hepatitis C (MAVERIC)

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)

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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