Maraviroc Efficacy for Hepatitis C

Hepatitis C Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881762
• Other study ID #: HP-00070324
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2017
• Est. completion date: March 27, 2019

Study information

• Verified date: October 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 27, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	Institute of Human Virology at the University of Maryland School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	ViiV Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc	Hepatitis C viral load was measured before starting maraviroc, and at 4 weeks of maraviroc.	Baseline to 4 weeks
Secondary	Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc	HCV viral load was measured before starting and at 7 days of maraviroc. Among participants that received Maraviroc in the first 4 weeks, HCV viral load was measured before first dose at day 0 and at day 7. Among participants that received Maraviroc in week 8 to 12, HCV viral load measured at day 56 before taking the first dose of Maraviroc and at day 63 (week 9) of study.	7 days