Maraviroc Efficacy for Hepatitis C

University of Maryland, Baltimore10 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Human Immunodeficiency Virus

Interventions

MaravirocDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

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

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc

Hepatitis C viral load was measured before starting maraviroc, and at 4 weeks of maraviroc.

Time frame: Baseline to 4 weeks

Secondary Outcomes

Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc

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.

Time frame: 7 days

Data from ClinicalTrials.gov

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