MAVERIC: Maraviroc Efficacy for Hepatitis C

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Completed

CT.gov ID

NCT02881762

Collaborator

ViiV Healthcare (Industry)

Enrollment

Location

Arms

21.8

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Human Immunodeficiency Virus	Drug: Maraviroc	Phase 4

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

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2017

Actual Primary Completion Date :

Mar 27, 2019

Actual Study Completion Date :

Mar 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Immediate start maraviroc To start maraviroc immediately after randomization.	Drug: Maraviroc 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. Other Names: Selzentry
Active Comparator: Delayed start maraviroc To start maraviroc 8 weeks after enrollment.	Drug: Maraviroc 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. Other Names: Selzentry

Arm

Intervention/Treatment

Active Comparator: Immediate start maraviroc

To start maraviroc immediately after randomization.

Drug: Maraviroc

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.

Other Names:

Selzentry

Active Comparator: Delayed start maraviroc

To start maraviroc 8 weeks after enrollment.

Drug: Maraviroc

Other Names:

Selzentry

Outcome Measures

Primary Outcome Measures

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 [12 to 16 weeks]
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).

Secondary Outcome Measures

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 [7 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy 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

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)