The objective of the study is to investigate the association between IL28 SNPs and the outcome of acute HCV treatment (response or non-response) in HIV-infected patients.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Association between IL28B SNPs and outcome of acute HCV treatment.
Secondary outcome
not applicable
Background summary
Recently, several studies have identified a few polymorphisms (SNPs) upstream
of the IL28B gene to be associated with the outcome of chronic hepatitis C
virus (HCV) treatment. However, to date no data exist about any possible
association between these polymorphisms and the outcome of acute HCV therapy.
In contrast to combination therapy with peginterferon-alfa/ ribavirin
(pegIFN/RBV) for chronic HCV infection, the optimal treatment for acute HCV is
being debated (combination therapy or mono-therapy pegIFN). In our unique
cohort treated with pegIFN mono-therapy we have a very high rate of
non-response. Therefore, we hypothesize that polymorphisms in the IL28B region
previously associated with clearance and non-response in chronic HCV treatment
are associated with non-response with pegIFN mono-therapy for acute HCV.
Study objective
The objective of the study is to investigate the association between IL28 SNPs
and the outcome of acute HCV treatment (response or non-response) in
HIV-infected patients.
Study design
Cohort study of HIV-infected patients treated for acute HCV in which single
measurement of IL28B SNPs will be performed.
Study burden and risks
10mL of blood will be obtained all 19 patients in this cohort. Those patients
with a non-response to therapy will benefit from participation because
information regarding their IL28B polymorphisms will possibly influence the
decisions regarding their future therapy for chronic HCV.
For the few patients successfully treated for acute HCV there is no direct
benefit in participation.
However, for all patients counts that the burden and risk of taking 1 blood
sample during regular blood measurements is minimal.
Heidelberglaan 100
3584 CX
Nederland
Heidelberglaan 100
3584 CX
Nederland
Listed location countries
Age
Inclusion criteria
all HIV-infected patients seen at the two outpatient clinics (UMCU and UMCG) (having been) treated with peginterferon-alfa mono-therapy for acute HCV.
Exclusion criteria
none, it's a excisting cohort of 19 treated patients with acute HCV and HIV
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31868.041.10 |