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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to initiation of treatment, up to 36 weeks
Awards & highlights

RAPID-HCV Trial 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.Check my eligibility
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.See study design
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.

RAPID-HCV Trial 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 have tested positive 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 have never been treated for hepatitis C.
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I am between 18 and 70 years old.
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I am between 18 and 70 years old.

RAPID-HCV Trial 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

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

RAPID-HCV 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
2,245 Previous Clinical Trials
14,816,382 Total Patients Enrolled
AbbVieIndustry Sponsor
950 Previous Clinical Trials
496,804 Total Patients Enrolled
5 Trials studying Hepatitis C Virus Infection
650 Patients Enrolled for Hepatitis C Virus Infection
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 Virus Infection Research Study Groups: Test and Treat plus Peer Mentors Intervention Arm, Standard of Care Referral Arm
Hepatitis C Virus Infection 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently taking part in this experiment?

"Affirmative. Clinicaltrials.gov's records show that this study is actively searching for participants, having been initially posted on August 6th 2021 and amended most recently on April 19th 2022. 250 subjects must be sourced from 5 distinct medical centres to complete the trial."

Answered by AI

Who is qualified to participate in this medical trial?

"This clinical trial, which is accepting around 250 participants, requires that potential enrollees have a hepatitis c diagnosis and be between 18 to 70 years of age."

Answered by AI

In what geographic locations can this experiment be accessed?

"This clinical trial is operating across 5 sites, including the University Health Network Toronto in Canada's largest city, Harvard University in Boston and The University of California San Francisco. There are also 2 additional locations for this study."

Answered by AI

Does this investigation restrict its participants to those 80 or younger?

"This medical trial is exclusively recruiting patients aged 18 to 70. Those under 18 or over 65 are eligible for 9 and 89 different trials, respectively."

Answered by AI

Is there an ongoing call for participants of this clinical research?

"Affirmative, the data available on clinicaltrials.gov demonstrate that this medical trial is currently enlisting participants - it was initially posted on August 6th 2021 and has since been updated April 19th 2022. This study requires 250 patients to be recruited from 5 different healthcare facilities."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Tennessee
How old are they?
18 - 65
What site did they apply to?
University of Alabama
What portion of applicants met pre-screening criteria?
Met criteria
~28 spots leftby Jan 2025