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Immunogenicity and Tolerance of Two Strategies of Anti-HAV Vaccination in HIV-infected Patients

NCT00190242 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2011-12-16

No results posted yet for this study

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 infected patients with CD4 count between 200 and 500 per mm3, co-infected or not with HBV and/or HCV. The factors influencing vaccine immunogenicity will be evaluate.

Conditions

  • HIV Infection

Interventions

DRUG

group1

Havrix at 1440IU was administrated à weeks S0, S4 and S24

DRUG

group2

Havrix (1440IU) was administrated at weeks S0 and S24 according to RECOMMANDATIONS

Sponsors & Collaborators

  • Ensemble contre le SIDA

    collaborator UNKNOWN

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Odile Launay, MD · Assistance Publique - Hôpitaux de Paris

  • Sophie GRABAR, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2006-10-31
Completion
2009-10-31

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00190242 on ClinicalTrials.gov