Maraviroc Efficacy for Hepatitis C (MAVERIC)

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; Human Immunodeficiency Virus
• Intervention / Treatment: Drug: Maraviroc

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Institute of Human Virology at the University of Maryland School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years old
2. Hepatitis C-infected without plans to undergo hepatitis C treatment for duration of the study
3. Human immunodeficiency virus (HIV) infected

4. 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

5. CD4 T cell counts > 100 cells/mm3
6. Non-cirrhotics and cirrhotics can be included
7. Willing to sign informed consent

Exclusion Criteria:

1. Age < 18
2. Unable to comply with study visits, research study visits, or is planning to relocate during the study.
3. Have any condition that the investigator considers a contraindication to study participation
4. Pregnancy or breast feeding
5. Decompensated liver disease (Child-Pugh C)
6. Imminent treatment for hepatitis C infection
7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limits of normal

8. 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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: ViiV Healthcare
• Investigators: Principal Investigator: Lyida Tang, MBChB, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): March 27, 2019
• Study Completion (Actual): March 27, 2019

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: hepatitis C virus (HCV); Maraviroc; Human immunodeficiency virus (HCV)
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Slow Virus Diseases; HIV Infections; Hepatitis; Hepatitis A; Hepatitis C; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; CCR5 Receptor Antagonists; Maraviroc
• Other Study ID Numbers: HP-00070324

Drug and device information, study documents

• 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