HIVVIhVhEpbNCT02847507
Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb)
An observational study of HIV and Hepatitis E, run by Centre Hospitalier de la côte Basque at 1 site in France.
Trial summary
Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France in 2016. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hepatitis E
- How many people
- 307 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to 31 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- HIV positive > 18
Who cannot join
- patient refusal for participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb): a Prospective Cohort Study
Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France in 2016.
Read the detailed 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.
- Conditions
- HIV, Hepatitis E
- Keywords
- HIV, Hepatitis E
- Medical subject headings
- Hepatitis E
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months time period
Secondary outcomes (1)
fibrotest score
patients infected with hepatitis B or hepatitis C viruses will have their liver status determined using fibrotest score.
Measured: 6 months time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de la côte Basque
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Toulouse
- Responsible party
- Principal investigator, VAREIL Marc-Olivier, Centre Hospitalier de la côte Basque
- Investigators
- Marc-olivier Vareil, phd, Principal investigator, centre hospitalier côte Basque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847507
- Sponsor's protocol ID
- VIH VHE pays basque
- Acronym
- VIhVhEpb
- Status last verified
- Jul 2018
- First submitted
- 20 Jul 2016
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb): a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02847507
- Acronym / sponsor ID
- VIhVhEpb / VIH VHE pays basque
- Conditions
- HIV, Hepatitis E
- Keywords
- HIV, Hepatitis E
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Centre Hospitalier de la côte BasqueUniversity, hospital or other
- Collaborators
- University Hospital, Toulouse
- Study start
- Jul 2016
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France in 2016.
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- HIV positive > 18
Key exclusion criteria (1 listed)
- patient refusal for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 6 months time period
Blood samples will be tested for specific immunoglobulins against hepatitis E virus
1 secondary outcome
fibrotest score
Time frame: 6 months time period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc-olivier Vareil, phd principal investigator
centre hospitalier côte Basque
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Hepatitis E, run by Centre Hospitalier de la côte Basque at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months time period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.