NCT02881762: MAVERIC

Maraviroc Efficacy for Hepatitis C

Completed Phase 4 Results posted Last updated 1 May 2024

What this trial tests

Phase 4 trial testing Maraviroc in Hepatitis C in 10 participants. Completed in 27 March 2019.

Timeline

1 June 2017

Primary endpoint
27 March 2019

27 March 2019

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 June 2017
Primary completion	27 March 2019
Estimated completion	27 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Maraviroc (MARAVIROC) — full drug profile →

Conditions studied

• Hepatitis C — all drugs for Hepatitis C →
• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →

Sponsor

University of Maryland, Baltimore

Who can join

18 and older, any sex, with Hepatitis C or Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc Primary · Baseline to 4 weeks

Hepatitis C viral load was measured before starting maraviroc, and at 4 weeks of maraviroc.

HCV viral load at baseline

Group	Value	95% CI
Maraviroc	2035071	± 1012880
No Maraviroc	2027648	± 1411027

HCV viral load at 4 weeks

Group	Value	95% CI
Maraviroc	2082302	± 1673228
No Maraviroc	1216383	± 769289.8

Change in HCV viral load at 4 weeks

Group	Value	95% CI
Maraviroc	47231	± 805651.4
No Maraviroc	-811264	± 1357476

Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc Secondary · 7 days

HCV viral load was measured before starting and at 7 days of maraviroc. Among participants that received Maraviroc in the first 4 weeks, HCV viral load was measured before first dose at day 0 and at day 7. Among participants that received Maraviroc in week 8 to 12, HCV viral load measured at day 56 before taking the first dose of Maraviroc and at day 63 (week 9) of study.

Group	Value	95% CI
Baseline, Pre-maraviroc	2035071	± 1012880
7 Days of Maraviroc	2138768	± 1732285

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 0 to end of study (week 12 for immediate start, week 16 for delayed start). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Maraviroc

Serious: 1/9 (11%)

Deaths: 0/9

No Maraviroc

Serious: 0/9 (0%)

Deaths: 0/9

Serious adverse events (1 terms)

Reaction	System	Maraviroc	No Maraviroc
Tibial plateau fracture	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Maraviroc	No Maraviroc
Vomiting	Gastrointestinal disorders	—	—
Presyncope	Nervous system disorders	—	—
Soft tissue injury	Musculoskeletal and connective tissue disorders	—	—
Bruise	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Tibial plateau fracture.

Data from ClinicalTrials.gov NCT02881762 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. New genetic and epigenetic insights into the chemokine system: the latest discoveries aiding progression toward precision medicine.
   Xu H, Lin S, Zhou Z, Li D, et al · · 2023 · cited 37× · PMID 37198402 · DOI 10.1038/s41423-023-01032-x
2. Targeting of G-protein coupled receptors in sepsis.
   Rehman A, Baloch NU, Morrow JP, Pacher P, et al · · 2020 · cited 11× · PMID 32197794 · DOI 10.1016/j.pharmthera.2020.107529