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

Completed

• Conditions: inflammation of the liver; 10021460; 10047438; viral hepatitis; 10019654

• Registration Number: NL-OMON33393
• Lead Sponsor: GGD Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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