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| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate start maraviroc | Active Comparator | To start maraviroc immediately after randomization. |
|
| Delayed start maraviroc | Active Comparator | To start maraviroc 8 weeks after enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 <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
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Lyida Tang, MBChB | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Human Virology at the University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
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Participants enrolled at the clinical research unit at the University of Maryland, Baltimore between June 2017 to April 2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Maraviroc First, Then No Maraviroc | Participants first received maraviroc, 150mg to 600mg (dose based on concomitant HIV antiretroviral regimen) twice a day for 4 weeks. After a washout period of 4 weeks, they then received no maraviroc for 4 weeks. |
| FG001 | No Maraviroc First, Then Maraviroc | Participants first received no maraviroc for 4 weeks. After a washout period of 4 weeks, they then received maraviroc, 150mg to 600mg (dose based on concomitant HIV antiretroviral regimen) twice a day for 4 weeks. Participants are then seen for their last visit 4 weeks after their last dose of maraviroc. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
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| Washout (4 Weeks) |
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| Second Intervention (4 Weeks) |
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| Followup No Maraviroc First Only (4 Wks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Maraviroc First, Then no Maraviroc | Participants first received maraviroc, 150mg to 600mg (dose based on concomitant HIV antiretroviral regimen) twice a day for 4 weeks. After a washout period of 4 weeks, they then received no maraviroc for 4 weeks. |
| BG001 | No Maraviroc First, Then Maraviroc |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who received at least one dose of each intervention and completed all study visits were included in the final analysis | Posted | Mean | Standard Deviation | International Units/ml | Baseline to 4 weeks |
|
Day 0 to end of study (week 12 for immediate start, week 16 for delayed start)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maraviroc | Participants who received Maraviroc daily either in the first 4 weeks or during week 8 to week 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tibial plateau fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | tripped over curb and sustained fracture requiring hospitalization. Not related to study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | 1 episode |
Small numbers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Lydia Tang | University of Maryland, Baltimore | 14107066567 | lydiatang@ihv.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2017 | Oct 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| 7 days |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
Participants first received no maraviroc for 4 weeks. After a washout period of 4 weeks, they then received maraviroc, 150mg to 600mg (dose based on concomitant HIV antiretroviral regimen) twice a day for 4 weeks. Participants are then seen for their last visit 4 weeks after their last dose of maraviroc. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hepatitis C viral load | Mean | Standard Deviation | International Units/ml |
|
| Alanine transaminase | Mean | Standard Deviation | International Units/ml |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | International Units/ml | 7 days |
|
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|
|
| 0 |
| 9 |
| 1 |
| 9 |
| 3 |
| 9 |
| EG001 | No Maraviroc | Participants who received No Maraviroc daily either the first 4 weeks or during weeks 8 to 12 of the study. | 0 | 9 | 0 | 9 | 1 | 9 |
|
| Presyncope | Nervous system disorders | Systematic Assessment | 1 episode, resolved after sitting down for 10 minutes |
|
| Soft tissue injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | stepped on sharp object and hurt big toe |
|
| Bruise | Skin and subcutaneous tissue disorders | Systematic Assessment | post phlebotomy bruise |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015658 | HIV Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |