Hepatitis CPhase 4MAVERICNCT02881762

Maraviroc Efficacy for Hepatitis C

A Phase 4 study testing Maraviroc in people with Hepatitis C and Human Immunodeficiency Virus, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Human Immunodeficiency Virus
What is being tested?: Maraviroc
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2017to 27 Mar 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 <50 IU/ml for ≥ 12 months
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

Who cannot join

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

Show all 11Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Institute of Human Virology at the University of Maryland School of Medicine
Baltimore, Maryland, 21201

Other trials in United States

About this study

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

Read the 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.

Conditions: Hepatitis C, Human Immunodeficiency Virus
Being tested: Maraviroc
Keywords: hepatitis C virus (HCV), Maraviroc, Human immunodeficiency virus (HCV)
Medical subject headings: Hepatitis C, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MaravirocDrug
Also called Selzentry
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.

Study groups in NCT02881762
Study group	Role	What they receive
Immediate start maraviroc	Active comparator	To start maraviroc immediately after randomization. Receives: Drug: Maraviroc
Delayed start maraviroc	Active comparator	To start maraviroc 8 weeks after enrollment. Receives: Drug: Maraviroc

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 4 weeks

Secondary outcomes (1)

Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc
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.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201727 Mar 2019

First posted29 Aug 2016 (estimated)
Study start1 Jun 2017
Primary completion27 Mar 2019
Study completion27 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis CStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02881762
Sponsor's protocol ID: HP-00070324
Acronym: MAVERIC
Status last verified: Oct 2023
First submitted: 10 Aug 2016
Last updated: 1 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer

All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02881762
Acronym / sponsor ID: MAVERIC / HP-00070324
Conditions: Hepatitis C, Human Immunodeficiency Virus
Keywords: hepatitis C virus (HCV), Maraviroc, Human immunodeficiency virus (HCV)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: ViiV Healthcare
Study start: 1 Jun 2017 (actual)
Primary completion: 27 Mar 2019 (actual)
Study completion: 27 Mar 2019 (actual)
First posted: 29 Aug 2016 (estimated)
Results: Posted 1 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate start maraviroc	Active comparator	Drug: MaravirocTo start maraviroc immediately after randomization.
Delayed start maraviroc	Active comparator	Drug: MaravirocTo start maraviroc 8 weeks after enrollment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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 <50 IU/ml for ≥ 12 months
CD4 T cell counts > 100 cells/mm3

Key exclusion criteria (11 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MaravirocAlso: SelzentryParticipants 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.	Drug	Delayed start maraviroc, Immediate start maraviroc

Primary outcome

The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc
Time frame: Baseline to 4 weeks
Hepatitis C viral load was measured before starting maraviroc, and at 4 weeks of maraviroc.

1 secondary outcome

Change in Hepatitis C Viral Loads From Baseline to Day 7 on Maraviroc
Time frame: 7 days

Results and safety

Results posted to the registry on 1 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Maraviroc First, Then No Maraviroc	5	5
No Maraviroc First, Then Maraviroc	5	4

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

Time frame: Baseline to 4 weeks. Mean (Standard Deviation). Unit: International Units/ml

Measure	Maraviroc n = 9	No Maraviroc n = 9
HCV viral load at baseline	2035071 (1012880)	2027648 (1411027)
HCV viral load at 4 weeks	2082302 (1673228)	1216383 (769289.8)
Change in HCV viral load at 4 weeks	47231 (805651.4)	-811264 (1357476)

Maraviroc vs No Maraviroc: p = 0.13, t-test, 2 sided

Population analysed: All participants who received at least one dose of each intervention and completed all study visits were included in the final analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 0 to end of study (week 12 for immediate start, week 16 for delayed start). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Maraviroc	1 of 9 (11.1%)	3 of 9 (33.3%)	0 of 9
No Maraviroc	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9

Limitations and caveats (from the sponsor): Small numbers.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C

Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lyida Tang, MBChB principal investigator

Assistant Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Maraviroc in people with Hepatitis C and Human Immunodeficiency Virus, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Change in Hepatitis C Viral Load From Baseline to 4 Weeks of Maraviroc or No Maraviroc (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02881762.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.