Sequellae of acute hepatitis C virus infection among HIV-infected MSM: the HIV/HCV primo cohort

Sequellae of acute hepatitis C virus infection among HIV-infected MSM: the HIV/HCV primo cohort - the HIV/HCV primo cohort

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33393

Enrollment

400

Registered

2009-04-03

Start date

2009-05-15

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammation of the liver viral hepatitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male - Having sex with men - 18 years or older - HIV seropositive - Acute HCV infection - Written informed consent

Exclusion criteria

Exclusion criteria: - No follow-up of patient at HIV-center;- Inability or unwillingness to provide informed consent or follow the requirements of the study

Design outcomes

Primary

Measure	Time frame
- Risk factors for acquiring HCV infection including socio-demographic, clinical, behavioural, virological and immunological variables - Rate of viral decline and predictors of viral decline with and without treatment - Proportion of patients with Rapid Virological Response (RVR) and Sustained Virological Response (SVR), defined as undetectable HCV RNA in serum at respectively week 4 of treatment and 24 weeks post therapy and predictors for a virological response - Incidence, timing and determinants of viral clearance following initial infection (untreated) - Incidence, determinants, clinical outcomes and consequences of HCV re- and superinfection following initial HCV infection - Morbidity and mortality following acute HCV and their determinants in HIV-infected individuals	—

Measure

Time frame

- Risk factors for acquiring HCV infection including socio-demographic, clinical, behavioural, virological and immunological variables - Rate of viral decline and predictors of viral decline with and without treatment - Proportion of patients with Rapid Virological Response (RVR) and Sustained Virological Response (SVR), defined as undetectable HCV RNA in serum at respectively week 4 of treatment and 24 weeks post therapy and predictors for a virological response - Incidence, timing and determinants of viral clearance following initial infection (untreated) - Incidence, determinants, clinical outcomes and consequences of HCV re- and superinfection following initial HCV infection - Morbidity and mortality following acute HCV and their determinants in HIV-infected individuals

—

Secondary

Measure	Time frame
- Prevalence of HCV-specific T-cell responses - Risk behaviour before, during and after HCV seroconversion and/or HCV treatment based on variables concerning sexual risk taking and drug use - Quality of life before , during and after HCV seroconversion and/or HCV treatment based on SF-36 questionnaires - Duration of HCV seroconversion - Predictors of HCV seroconversion - HAART response in HIV/acute HCV coinfection measured by HIV viral load and CD4 count - Side effects of HCV treatment	—

Measure

Time frame

- Prevalence of HCV-specific T-cell responses - Risk behaviour before, during and after HCV seroconversion and/or HCV treatment based on variables concerning sexual risk taking and drug use - Quality of life before , during and after HCV seroconversion and/or HCV treatment based on SF-36 questionnaires - Duration of HCV seroconversion - Predictors of HCV seroconversion - HAART response in HIV/acute HCV coinfection measured by HIV viral load and CD4 count - Side effects of HCV treatment

—

Countries

Netherlands

Outcome results