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Rapid Hepatitis C Treatment Access for Drug Users (RAPID-HCV Trial)
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.
RAPID-HCV Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRAPID-HCV Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RAPID-HCV Trial Design
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Who is running the clinical trial?
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- I have never been treated for hepatitis C.I have HIV and am either not on ART with a CD4 count over 500, or on a stable ART regimen.I have a history of liver cancer.I have tested positive for hepatitis C.I can stop taking certain medications like some cholesterol drugs and others listed, 14 days before starting the trial.I have HIV and am either not on ART with a CD4 count over 500, or on a stable ART regimen.I am not taking any prohibited medications like St. John's Wort or rifampin.I have never been treated for hepatitis C.I have never had severe liver problems like encephalopathy, bleeding varices, or ascites.You are a female of childbearing potential.You have an allergy or sensitivity to the ingredients in the study drugs.I am between 18 and 70 years old.I am using effective birth control and will continue for 30 days after my last dose.I am between 18 and 70 years old.
- Group 1: Test and Treat plus Peer Mentors Intervention Arm
- Group 2: Standard of Care Referral Arm
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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