NCT02881762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2019

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

May 1, 2024

Completed
Last Updated

May 1, 2024

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

August 10, 2016

Results QC Date

October 26, 2022

Last Update Submit

April 24, 2024

Conditions

Hepatitis CHuman Immunodeficiency Virus

Keywords

hepatitis C virus (HCV)MaravirocHuman immunodeficiency virus (HCV)

Outcome Measures

Primary Outcomes (1)

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

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

    Baseline to 4 weeks

Secondary Outcomes (1)

  • Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc

    7 days

Study Arms (2)

Immediate start maraviroc

ACTIVE COMPARATOR

To start maraviroc immediately after randomization.

Drug: Maraviroc

Delayed start maraviroc

ACTIVE COMPARATOR

To start maraviroc 8 weeks after enrollment.

Drug: Maraviroc

Interventions

MaravirocDRUG

Participants will receive 4 weeks of maraviroc (dosing based on concomitant HIV antiretroviral regimen). Serial measurements of HCV viral load will be obtained before, during, and after maraviroc exposure. Study duration will be approximately 12 to 16 weeks.

Also known as: Selzentry
Delayed start maravirocImmediate start maraviroc

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \<50 IU/ml for ≥ 12 months
  • a. One virologic blip ≤ 400 copies/ml permissible within the 12 months
  • CD4 T cell counts \> 100 cells/mm3
  • Non-cirrhotics and cirrhotics can be included
  • Willing to sign informed consent

You may not qualify if:

  • Age \< 18
  • Unable to comply with study visits, research study visits, or is planning to relocate during the study.
  • Have any condition that the investigator considers a contraindication to study participation
  • Pregnancy or breast feeding
  • Decompensated liver disease (Child-Pugh C)
  • Imminent treatment for hepatitis C infection
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Virology at the University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Hepatitis CAcquired Immunodeficiency Syndrome

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHIV InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Small numbers.

Results Point of Contact

Title
Dr Lydia Tang
Organization
University of Maryland, Baltimore
lydiatang@ihv.umaryland.edu
14107066567

Study Officials

  • Lyida Tang, MBChB

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 29, 2016

Study Start

June 1, 2017

Primary Completion

March 27, 2019

Study Completion

March 27, 2019

Last Updated

May 1, 2024

Results First Posted

May 1, 2024

Record last verified: 2023-10

Locations

US(1)