A Pilot Study to Evaluate Anti-Hepatitis C Virus Effect of Maraviroc in Patients Co-infected With Human Immunodeficiency Virus (HIV) and Hepatitis C
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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)
Arms & Interventions
Immediate start maraviroc
To start maraviroc immediately after randomization.
Intervention: Maraviroc (Drug)
Delayed start maraviroc
To start maraviroc 8 weeks after enrollment.
Intervention: Maraviroc (Drug)
Outcomes
Primary Outcomes
The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc
Time Frame: Baseline to 4 weeks
Hepatitis C viral load was measured before starting maraviroc, and at 4 weeks of maraviroc.
Secondary Outcomes
- Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc(7 days)
Investigators
Lydia Tang
Assistant Professor
University of Maryland, Baltimore