Phase 4
Completed N=10
Maraviroc Efficacy for Hepatitis C
Source: ClinicalTrials.gov NCT02881762 ↗Enrolled (actual)
10
Serious AEs
5.6%
Results posted
May 2024
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-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 |
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)
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. Informational only — not medical advice.