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Phase 4 N=10 Randomized Treatment

Maraviroc Efficacy for Hepatitis C

Hepatitis C · Human Immunodeficiency Virus

Bottom Line

View on ClinicalTrials.gov: NCT02881762 ↗
Enrolled (actual)
10
Serious AEs
5.6%
Results posted
May 2024
Primary outcome: Primary: The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc — 2035071; 2027648; 2082302; 1216383 International Units/ml — p=0.13

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Maraviroc (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Maryland, Baltimore
Primary completion
Mar 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc		 2035071; 2027648; 2082302; 1216383; 47231; -811264 0.13
SECONDARY
Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc		 2035071; 2138768 >0.5

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.

Eligibility Criteria

Inclusion Criteria

  • 18 years old
  • Hepatitis C-infected without plans to undergo hepatitis C treatment for duration of the study
  • Human immunodeficiency virus (HIV) infected
  • Currently receiving anti-retroviral therapy with HIV viral load 100 cells/mm3
  • Non-cirrhotics and cirrhotics can be included
  • Willing to sign informed consent

Exclusion Criteria

  • Age 2.5 times the upper limits of normal
  • 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02881762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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