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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
Sex
Ages
Volunteers
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:
Primary purpose
Allocation
Interventional model
Masking
10 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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