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Hepatitis C Virus InfectionNCT04768517

HCV Reinfection in in HIV/HCV-coinfected Patients Achieving SVR by Antiviral Therapy

An observational study of Hepatitis C Virus Infection and Hepatitis C Virus Infection, Response to Therapy of, run by National Taiwan University Hospital at 7 sites in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Chronic hepatitis C virus (HCV) infection remains a health burden in people living with human immunodeficiency virus (HIV). Interferon (IFN)-based therapy is the treatment of choice for HCV infection for HIV coinfected patients in earlier years. Read more about this study

Who is it for?
Ages 20 years and older
How many people
300 participants
Where
7 sitesTaiwan
Study dates
9 Feb 2021to 1 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HIV/HCV-coinfected patients who undergo antiviral therapy for hepatitis C virus infection and who achieve sustained virologic response

Who may be able to join

  • Age old than 20 years old
  • Patients with human immunodeficiency virus coinfection (HIV) during IFN-based or IFN-free antiviral therapy for hepatitis C virus (HCV) infection
  • Patients achieving SVR, defined as undetectable serum HCV RNA at week 12 off-therapy

Who cannot join

  • Poor access to sites for venipuncture

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Taiwan7 sites, 7 recruiting
  • National Taiwan University Hospital, Yun-Lin Branch

    Douliu, 640

    Chen-Hua Liu, MD, +886-972651880, jacque_liu@mail2000.com.tw

    Recruiting
  • China Medical University Hospital

    Taichung, 40447

    Cheng-Yuan Peng, MD, +886422052121, cypeng@mail.cmuh.org.tw

    Recruiting
  • Taichung Veterans General Hospital

    Taichung, 40705

    Sheng-Shun Yang, MD, +886423592525, yansh@vghtc.gov.tw

    Recruiting
  • National Taiwan University Hospital

    Taipei, 10002

    Chen-Hua Liu, MD, +886-223123456 ext. 63572, jacque_liu@mail2000.com.tw

    Recruiting
  • Taipei City Hospital, Ren-Ai Branch

    Taipei, 10629

    Chih-Lin Lin, MD, +886227093600, DAB53@tpech.gov.tw

    Recruiting
  • Taipei Medical University Hospital

    Taipei, 110

    Wei-Yu Kao, MD, +886227372181, 121021@tmuh.org.tw

    Recruiting
  • Tri-Service General Hospital

    Taipei

    Yu-Lueng Shih, MD, +886287923311, albreb@ms28.hinet.net

    Recruiting

Other trials in Taiwan

About this study

Official title: Risk of Hepatitis C Virus Reinfection in Human Immunodeficiency Virus and Hepatitis C Virus Coinfected Patients Achieving Sustained Virologic Response by Antiviral Therapy

Chronic hepatitis C virus (HCV) infection remains a health burden in people living with human immunodeficiency virus (HIV). Interferon (IFN)-based therapy is the treatment of choice for HCV infection for HIV coinfected patients in earlier years. However, the treatment responses are far from ideal and the treatment-emergent adverse events (AEs) are frequently encountered. Based on the excellent efficacy and safety, IFN-free direct acting antivirals (DAAs) have been the mainstay of therapy for HCV. Furthermore, the world health organization (WHO) has set the goal of global HCV elimination by 2030. The microelimination of HCV among HIV/HCV-coinfected patients is also listed as the prioritized target by WHO. Although the overall treatment response has improved dramatically during the past 5-10 years, several studies have indicated the HIV/HCV-coinfected patients had high risks of reinfection following successful antiviral treatment. The risk of HCV reinfection was reported to be 24.6% among HIV-positive men who have sex with men (MSM) in Austria, German, France and the United Kingdom who attained sustained virologic response (SVR) by IFN-based therapy. Two recent studies from Canada showed that the incidence of HCV reinfection in HIV-positive patients was higher that HIV-negative patients (3.44 vs. 1.13 per 100 person-year; 2.56 vs. 1.12 per 100 person-year). In Taiwan, 14.1% of the HIV-positive patients had HCV reinfection following treatment-induced or spontaneous viral clearance, resulting an incidence of 8.2 per 100 person-year with a total of 218.3 person-years of follow-up for these patients.

Because data regarding to the HCV reinfection in HIV-positive patients are still limited, where a more comprehensive assessment of HCV reinfection is important based on the perspectives of HCV microelimination among HIV-positive patients in Taiwan, the investigators thus aim to conduct a long-term, large-scale cohort study to assess the risk of HCV reinfection in HIV-positive patients achieving SVR after IFN-based or IFN-free therapies, and to assess the factors associated with different risks of reinfection in these patients.

Read the detailed description

Chronic hepatitis C virus (HCV) infection remains a health burden in people living with human immunodeficiency virus (HIV). Compared to the midpoint prevalence rate of HCV coinfection to be 2.4% in the general HIV-positive population, the prevalence rates are higher among bisexual men (4.0%), gay men (6.4%), and people who inject drugs (PWIDs) (82.4%). Following the widespread use of antiretroviral therapy (ART) for HIV which improves the health outcome by reducing the acquired immunodeficiency syndrome (AIDS)-related deaths, the liver-related death has become a frequent cause of non-AIDS-related deaths in HIV-positive population. If HCV is left untreated, the HIV/HCV-coinfected patients may have higher risks of developing hepatic decompensation or hepatocellular carcinoma (HCC) than HCV-monoinfected patients due to the accelerated progression of hepatic fibrosis.

Interferon (IFN)-based therapy is the treatment of choice for HCV infection for HIV coinfected patients in earlier years. However, the treatment responses are far from ideal and the treatment-emergent adverse events (AEs) are frequently encountered. Based on the excellent efficacy and safety, IFN-free direct acting antivirals (DAAs) have been the mainstay of therapy for HCV. Furthermore, the world health organization (WHO) has set the goal of global HCV elimination by 2030. The microelimination of HCV among HIV/HCV-coinfected patients is also listed as the prioritized target by WHO.

Although the overall treatment response has improved dramatically during the past 5-10 years, several studies have indicated the HIV/HCV-coinfected patients had high risks of reinfection following successful antiviral treatment. The risk of HCV reinfection was reported to be 24.6% among HIV-positive men who have sex with men (MSM) in Austria, German, France and the United Kingdom who attained sustained virologic response (SVR) by IFN-based therapy. Two recent studies from Canada showed that the incidence of HCV reinfection in HIV-positive patients was higher that HIV-negative patients (3.44 vs. 1.13 per 100 person-year; 2.56 vs. 1.12 per 100 person-year). In Taiwan, 14.1% of the HIV-positive patients had HCV reinfection following treatment-induced or spontaneous viral clearance, resulting an incidence of 8.2 per 100 person-year with a total of 218.3 person-years of follow-up for these patients.

Because data regarding to the HCV reinfection in HIV-positive patients are still limited, where a more comprehensive assessment of HCV reinfection is important based on the perspectives of HCV microelimination among HIV-positive patients in Taiwan, the investigators thus aim to conduct a long-term, large-scale cohort study to assess the risk of HCV reinfection in HIV-positive patients achieving SVR after IFN-based or IFN-free therapies, and to assess the factors associated with different risks of reinfection in these patients.

Keywords
Hepatitis C virus, Human immunodeficiency virus, Sustained virologic response, Reinfection
Medical subject headings
Hepatitis C, Acquired Immunodeficiency Syndrome, Coinfection, Reinfection

What is being measured

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

  1. Cumulative reinfection rate

    Time-dependent accumulative proportion of participants with evidence of resurgence of HCV viremia from the time point of viral clearance after antiviral therapy to the time point of last follow-up

    Measured: Through study completion, an average of 3 years

Timeline

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

  1. First posted24 Feb 2021
  2. Study start9 Feb 2021
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04768517
Sponsor's protocol ID
202012260RIND
Status last verified
Feb 2021
First submitted
21 Feb 2021
Last updated
26 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C Virus Infection and Hepatitis C Virus Infection, Response to Therapy of, run by National Taiwan University Hospital at 7 sites in Taiwan.

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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Taiwan. 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Chen-Hua Liu, MD (+886-223123456 ext. 63572, jacque_liu@mail2000.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative reinfection rate (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Feb 2021.

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