Maraviroc Efficacy for Hepatitis C

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study to Evaluate Anti-Hepatitis C Virus Effect of Maraviroc in Patients Co-infected With Human Immunodeficiency Virus (HIV) and Hepatitis C

Conditions
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Hepatitis C, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: Maraviroc


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate start maraviroc<br>To start maraviroc immediately after randomization. | Drug: Maraviroc<br>* 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.<br>* Other names: Selzentry;|
| Active Comparator: Delayed start maraviroc<br>To start maraviroc 8 weeks after enrollment. | Drug: Maraviroc<br>* 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.<br>* Other names: Selzentry;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in hepatitis C viral load from baseline to end of maraviroc treatment, and end of study (weeks 4, 8, 12 and 16) in people infected with both human immunodeficiency virus and hepatitis C with addition of maraviroc | Maraviroc will be added to existing human immunodeficiency virus anti-retroviral regimens among participants infected with both hepatitis C and human immunodeficiency virus. Hepatitis C viral loads will be measured at the above time points. For participants randomized to immediate start of maraviroc, maraviroc treatment will occur from day 0 to week 4, and the last viral load will be on week 12 (no week 16 tests). Participants randomized to the delayed start group will receive maraviroc treatment from week 8 to week 12, and therefore hepatitis C viral load will be measured at baseline and week 4 of study participation (prior to maraviroc treatment) and the last hepatitis C viral load test will occur at week 16 of the study (4 weeks after completing maraviroc treatment). | 12 to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hepatitis C viral loads from baseline to days 2, 3, 5 and 7 of starting maraviroc in people infected with both human immunodeficiency virus and hepatitis C | Maraviroc will be added to existing human immunodeficiency virus anti-retroviral regimens among participants infected with both hepatitis C and human immunodeficiency virus. Serial blood tests for Hepatitis C viral load will be obtained during the first 7 days of maraviroc initiation | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C virus (HCV), Maraviroc, Human immunodeficiency virus (HCV)