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Isolated Anti-HBc Serological Profile in HIV Infected Patients: Immunological, Virological Characteristics and Response to Hepatitis B Vaccination (ANRSHBEP03)

A

ANRS, Emerging Infectious Diseases

Status

Completed

Conditions

HIV Infection
Hepatitis B

Treatments

Other: blood sampling

Study type

Observational

Funder types

Other

Identifiers

NCT02323308
2010-A00511-38 (Other Identifier)
ANRS HB EP 03 CISOVAC

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

55 participants in 1 patient group

vaccination
Description:
Anti-HBV vaccine injection
Treatment:
Other: blood sampling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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