Clinical trial NCT02881762: Maraviroc Efficacy for Hepatitis C
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Human Immunodeficiency Virus
Keywords: hepatitis C virus (HCV)
Maraviroc
Human immunodeficiency virus (HCV)
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2016-08-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc
timeFrame: Baseline to 4 weeks
Secondary outcomes:
measure: Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc
timeFrame: 7 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Institute of Human Virology at the University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: Assistant Professor
name: Lyida Tang, MBChB
role: PRINCIPAL_INVESTIGATOR
References: