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Sequelae of acute hepatitis C virus infection among HIV positive MSM, HIV negative MSM and HIV positive heterosexuals: the MOSAIC cohort.

Sequelae of acute hepatitis C virus infection among HIV positive MSM, HIV negative MSM and HIV positive heterosexuals: the MOSAIC cohort. - the MOSAIC cohort

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45164
Enrollment
500
Registered
2015-01-19
Start date
2015-07-01
Completion date
Unknown
Last updated
2024-04-23

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

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - male of female - 18 years or older - MSM or heterosexual - HIV positive of HIV negative - acute HCV infection - written informed consent

Exclusion criteria

Exclusion criteria: - no follow-up of patient at an HIV or Hepatology outpatient clinic - inability or unwillingness to provide informed consent or follow the requirements of the study

Design outcomes

Primary

MeasureTime frame
1 Frequency and determinants of acquiring primary , re- and superinfection with HCV (sociodemographic, clinical, behavioural, virological, immunological and genetic variables) 2 A: HCV viral load dynamics according to treatment status and other determinants B: Proportion of patients with Rapid Virological Response (RVR), Early Virological Response (EVR) and Sustained Virological Response (SVR), defined by current and future (inter)national guidelines, according to weeks of treatment or weeks post therapy C: Predictors for Virological Response 3 A: Morbidity following acute HCV and its determinants in HIV infected and HIV-uninfected individuals B: Mortality following acute HCV and its determinants in HIV infected and HIV-uninfected individuals 4 Overlap between HIV and HCV epidemics 5 Driving factors for the HCV outbreak including sociodemographic, behavioural and biological variables

Secondary

MeasureTime frame
1. A: Probability of achieving HCV clearance in the absence of therapy B: Predictors of HCV clearance based on sociodemographic, clinical, virological, immunological and genetic variables 2. HCV-specific immunology: T-cells, B-cells and the innate responses 3. Time to HCV antibody seroconversion and its determinants 4. Response to cART in HIV/acute HCV coinfection, defined as short-term changes in HIV RNA and CD4 count levels 5. Liver fibrosis progression based on fibroscan, echo, biopsy and non invasive blood test scores 6. A: Risk behaviour before and after acute HCV infection and/or HCV treatment based on variables concerning sexual risk taking and drug use B: Quality of life after acute HCV infection and before, during and after HCV treatment 7. Further spread of HCV by sexual transmission and the impact of awareness, early diagnosis and treatment on this (within mathematical models) 8. Level of clustering of HCV based on sequence data 9. Host genetic factors for susceptibility and outcome of acute HCV infection

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)