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Antiviral

Rapid Hepatitis C Treatment Access for Drug Users (RAPID-HCV Trial)

N/A
Recruiting
Led By Oluwaseun Falade-Nwulia, MBBS, MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HCV treatment naïve (no prior treatment with an approved or investigational oral DAA therapy)
If co-infection with Human Immunodeficiency Virus (HIV) is documented, the subject must be anti-retroviral treatment (ART) naïve with CD4 T cell count >500 cells/mm3 OR on a stable ART regimen (containing only permissible ART - Raltegravir; dolutegravir; Rilpivirine; Elvitegravir/cobicistat; Tenofovir disoproxil fumarate; Tenofovir alafenamide; Emtricitabine; Lamivudine and/or Abacavir, bictegravir)
Must not have
History of hepatocellular carcinoma (HCC)
Subject is not able or willing to safely discontinue the prohibited medications or supplements listed below at least 14 days prior to the first dose of GLE/PIB: some HMG-CoA reductase inhibitors, astemizole, cisapride, terfenadine, ethinyl estradiol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to initiation of treatment, up to 36 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two ways to give HCV treatment to people who also use drugs and are in an outpatient opioid treatment program. One group will get 8 weeks of glecaprevir/pibrentasvir treatment and support from a peer-mentor, while the other group will just be referred to an offsite HCV treatment location.

Who is the study for?
Adults aged 18-70 with Hepatitis C who use drugs and are in an opioid treatment program can join. They must be new to HCV treatment, may have HIV if treated or with high CD4 counts, and not pregnant or breastfeeding. Those with severe liver disease, other hepatitis types, low platelets, or taking certain medications cannot participate.
What is being tested?
The trial compares immediate HCV treatment using glecaprevir/pibrentasvir plus support from a peer mentor versus the usual care of being referred to an offsite clinic for those diagnosed at the opioid treatment program.
What are the potential side effects?
Possible side effects of glecaprevir/pibrentasvir include headaches, fatigue, nausea, and sometimes allergic reactions. Each person's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never been treated for hepatitis C.
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I have HIV and am either not on ART with a CD4 count over 500, or on a stable ART regimen.
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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of liver cancer.
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I can stop taking certain medications like some cholesterol drugs and others listed, 14 days before starting the trial.
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I am not taking any prohibited medications like St. John's Wort or rifampin.
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I have never had severe liver problems like encephalopathy, bleeding varices, or ascites.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to initiation of treatment, up to 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to initiation of treatment, up to 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participants Who Initiate HCV Therapy
Secondary study objectives
HCV Treatment Completion
Therapeutic procedure
Time to HCV Treatment Initiation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Test and Treat plus Peer Mentors Intervention ArmExperimental Treatment1 Intervention
Participants offered 8 weeks of glecaprevir/pibrentasvir (GLE/PIB) at OTP plus peer support.
Group II: Standard of Care Referral ArmActive Control1 Intervention
Participants referred to offsite (non-OTP) location for HCV treatment.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,323 Previous Clinical Trials
14,874,183 Total Patients Enrolled
18 Trials studying Hepatitis C
154,734 Patients Enrolled for Hepatitis C
AbbVieIndustry Sponsor
1,022 Previous Clinical Trials
520,055 Total Patients Enrolled
110 Trials studying Hepatitis C
32,705 Patients Enrolled for Hepatitis C
Oluwaseun Falade-Nwulia, MBBS, MPHPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
760 Total Patients Enrolled

Media Library

Glecaprevir/pibrentasvir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT04677153 — N/A
Hepatitis C Research Study Groups: Test and Treat plus Peer Mentors Intervention Arm, Standard of Care Referral Arm
Hepatitis C Clinical Trial 2023: Glecaprevir/pibrentasvir Highlights & Side Effects. Trial Name: NCT04677153 — N/A
Glecaprevir/pibrentasvir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04677153 — N/A
~3 spots leftby Jan 2025
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