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NCT02847507 Clinical Trial

Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb)

HIV Clinical Trial

— VIhVhEpb  

Official title:
Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb): a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02847507
Other study ID # VIH VHE pays basque
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2016
Est. completion date January 31, 2018

Study information
Verified date July 2018
Source Centre Hospitalier de la côte Basque
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France in 2016.

Description:

Study of seroprevalence of hepatitis E among patient followed and treated in "centre Hospitalier de la Côte Basque" for HIV infections. Study of acquisition of hepatitis E , and determination of liver status using fibrotest in co-infected patients with hepatis C and / or B.

Recruitment information / eligibility
Status Completed
Enrollment 307
Est. completion date January 31, 2018
Est. primary completion date January 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- HIV positive > 18

Exclusion Criteria:

- patient refusal for participation

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre hospitalier de la Côte Basque Bayonne

Sponsors (2)
Lead Sponsor Collaborator
Centre Hospitalier de la côte Basque University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) for hepatitis E in blood sample of each patients. Positive sample for both IgM and IgG will be confirmed using polymerase chain reaction (PCR) techniques Blood samples will be tested for specific immunoglobulins against hepatitis E virus 6 months time period
Secondary fibrotest score patients infected with hepatitis B or hepatitis C viruses will have their liver status determined using fibrotest score. 6 months time period
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