Maraviroc Efficacy for Hepatitis C

Phase 4

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Immediate start maraviroc	Maraviroc	To start maraviroc immediately after randomization.
Delayed start maraviroc	Maraviroc	To start maraviroc 8 weeks after enrollment.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc	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.

Locations (1): Institute of Human Virology at the University of Maryland School of Medicine
🇺🇸
Baltimore, Maryland, United States
Institute of Human Virology at the University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States