HIV Infections Clinical Trial
Official title:
Randomised Open Label Clinical Trial of the Immune Response to Hepatitis B Vaccination in HIV-infected Persons.
In this study we compare the efficacy of two different HBV-vaccination schedules in HIV-infected persons concerning immune response and compliance. Short schedule: t=0,1,3 weeks and standard schedule: t=0,1,6 months.
It is known that HIV-infected persons are more prone to develop chronic hepatitis B
infection when they get infected with this virus. After developing chronic hepatitis B these
patients are more likely to get livercirrosis and hepatocellular carcinoma (Bodsworth et
al.).
Hepatitis B vaccination is available and the vaccine is about 95% protective in preventing
immunocompetent persons from developing chronic hepatitis B infection (Lemon). The response
on this vaccin is less effective in HIV-infected persons (Carne et al.). Furthermore there
is a compliance problem in the standard scheme.
In this study we compare the efficacy of two different HBV vaccination schedules in
HIV-infected persons concerning immune response and compliance. A short schedule: t=0,1,3
weeks, in which there are good results concerning immune response and compliance in
immunocompetent persons (Saltog et al.) and the standard schedule: t=0,1,6 months. Patients
not immune at week 28 will be offered boostervaccination. This consists of double doses at
t=0,1,2 months.
800 persons are needed to show non-inferiority with lower margin of 10% of the short
schedule in comparison with the control group. Powercalculation is 80%. Randomization is
stratified according to CD4 count(CD4 <200, 200-500, >500).
The hypothesis of the study is a better compliance and a comparable immune response in the
short schedule, through which persons will be protected against hepatitis B in an early
stage.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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