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Isolated Anti-HBc Serological Profile in HIV Infected Patients: Immunological, Virological Characteristics and Response to Hepatitis B Vaccination

NCT ID: NCT02323308

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-06-30

Brief Summary

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The aim of study is to describe the clinical, immunological, serological, virological and therapeutic characteristics of HIV+ patients harboring isolated anti-HBc profile and to assess the response to vaccination in these patients.

Detailed Description

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Conditions

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HIV Infection Hepatitis B

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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vaccination

Anti-HBV vaccine injection

blood sampling

Intervention Type OTHER

Interventions

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blood sampling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HIV+ adults patients
* negative HBsAg
* negative a-HBs Ab
* positive HBc Ab
* without HBV - vaccination
* CD4 cell above 200 /mm3
* HIV viral load below 50 copies/mL

Exclusion Criteria

* positive HBs antigenemia in the past
* transaminitis above fivefold upper normal limit
* PT\<50% or Platelet \<50 000/mm3
* ongoing opportunistic infection
* ongoing or recent systemic corticoid or immunomodulatory therapy, splenectomy, pregnancy, contra-indication to intramuscular injection, familial history of neurological disease.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lionel Piroth

Role: PRINCIPAL_INVESTIGATOR

CHU DIJON

Locations

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Chu Dijon

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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2010-A00511-38

Identifier Type: OTHER

Identifier Source: secondary_id

ANRS HB EP 03 CISOVAC

Identifier Type: -

Identifier Source: org_study_id