Maraviroc Efficacy for Hepatitis C

• Status: Completed
• Trial end date: 2019-03-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: ViiV Healthcare
• Treatments: Maraviroc

Criteria

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)