Back to resultsMaraviroc Efficacy for Hepatitis C (MAVERIC)
Primary Purpose
Hepatitis C, Human Immunodeficiency Virus
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Maraviroc
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring hepatitis C virus (HCV), Maraviroc, Human immunodeficiency virus (HCV)
Eligibility Criteria
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)
Sites / Locations
- Institute of Human Virology at the University of Maryland School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Immediate start maraviroc
Delayed start maraviroc
Arm Description
To start maraviroc immediately after randomization.
To start maraviroc 8 weeks after enrollment.
Outcomes
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
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
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
Full Information
NCT ID
NCT02881762
First Posted
August 10, 2016
Last Updated
August 15, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
ViiV Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02881762
Brief Title
Maraviroc Efficacy for Hepatitis C
Acronym
MAVERIC
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
ViiV Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Human Immunodeficiency Virus
Keywords
hepatitis C virus (HCV), Maraviroc, Human immunodeficiency virus (HCV)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate start maraviroc
Arm Type
Active Comparator
Arm Description
To start maraviroc immediately after randomization.
Arm Title
Delayed start maraviroc
Arm Type
Active Comparator
Arm Description
To start maraviroc 8 weeks after enrollment.
Intervention Type
Drug
Intervention Name(s)
Maraviroc
Other Intervention Name(s)
Selzentry
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
12 to 16 weeks
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyida Tang, MBChB
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Human Virology at the University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Maraviroc Efficacy for Hepatitis C
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