Maraviroc Efficacy for Hepatitis C



Status:Completed
Conditions:HIV / AIDS, HIV / AIDS, HIV / AIDS, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:June 1, 2017
End Date:March 27, 2019

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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.

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.

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)
We found this trial at
1
site
725 West Lombard Street
Baltimore, Maryland 21201
Phone: 410-706-6567
?
mi
from
Baltimore, MD
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