Status:
COMPLETED
Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ensemble contre le SIDA
GlaxoSmithKline
Conditions:
HIV Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
Immunogenicity is reduced in immunocompromised patients. The aim of this prospective randomized study is to evaluate tolerance and immunogenicity of 2 doses versus 3 doses of anti-HAV vaccine in HIV-1...
Detailed Description
RECOMMANDATIONS for hepatitis A vaccination is the same for HIV-infected patients than for general population. However, immunogenicity induced with 2 doses of anti-HAV vaccine is lower in HIV-infected...
Eligibility Criteria
Inclusion
- VIH-1 infection, aged 18-55 years negative anti-HAV IgG CD4 cell count between 200 and 500/mm3
Exclusion
- prior anti-HAV vaccination immunosuppressive treatment splenectomy Prothrombin time \< 50%, platelets\< 50 000/mm3 fever serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) activity \> 2 ULN for non co-infected patients, \> 5 ULN for co-infected patients
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00190242
Start Date
June 1 2003
End Date
October 1 2009
Last Update
December 16 2011
Active Locations (2)
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1
CIC de vaccinologie Cochin Pasteur, Service de médecine interne, hôpital Cochin
Paris, France, 75014
2
CISIH, Hôpital de Strasbourg
Strasbourg, France, 67091