NCT02847507

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

July 20, 2016

Last Update Submit

July 16, 2018

Conditions

HIVHepatitis E

Keywords

HIVHepatitis E

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • fibrotest score

    6 months time period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients seropositve for HIV and treated in the" Centre Hospitalier de la côte Basque" are considered for enrollment. Patient must be \> 18 years, and followed or treated in the investigators institution

You may qualify if:

  • HIV positive \> 18

You may not qualify if:

  • patient refusal for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier de la Côte Basque

Bayonne, 64100, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serological status for hepatitis E, hepatits B and hepatitis C, and biological follow up of HIV patients including fibrotest for hepatis b/ or C positive patients

MeSH Terms

Conditions

Hepatitis E

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Marc-olivier Vareil, phd

    centre hospitalier côte Basque

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 28, 2016

Study Start

July 1, 2016

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

FR(1)