The purpose of this study is to determine whether an immunization schedule is beneficial to HIV-infected patients with CD4 recount over 500 cells/mm3 and undetectable viral load.
As HIV-infected patients are considered immunocompromised, it is generally recommended that they have to receipt appropriate vaccines. However data are conflicting concerning potential harmful effects following the administration of commercial vaccines in HIV-infected patients. Transient increases ("blips") in the viral load have been described associated with a single dose of vaccine, with the potential risk of developing resistance to HAART. On the other hand, there has been described that patients with blips can have an increase in HIV-specific immune responses, which may help to improve the viral control. Comparison: We have performed a clinical trial to evaluate the effect of a vaccination program in successfully treated HIV-infected adults on HAART compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
26
Department of Infectious Diseases, Hospital Clínic, C/Villarroel 170
Barcelona, Barcelona, Spain
Times viral load increases over 20.000 copies/mL.
Development of resistance to antiretroviral therapy during the 18 months of the study
Appearance of specific CD4 proliferative responses against HIV during the 18 months of the study
Appearance of specific cytotoxic responses against HIV during the 18 months of the study
Number of patients under 5000 copies/mL after 6 months of stopping HAART
Development of symptoms C during the 18 months of the study
Deaths during the 18 months of the study
Toxicity during the 18 months of the study
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