Human Immunodeficiency Virus; HIV Clinical Trial
Official title:
Ex Vivo Study of Immune-Reconstitution Kinetics in HIV-infected ARV-naive Subjects, With Advanced Disease, Starting a Darunavir/Ritonavir or Efavirenz Based HAART (IMMUNO Study)
The purpose of this study is to study the kinetics (study of the rate of change) of immune recovery quality and function in stored plasma blood samples of treatment-naive (not previously treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (HIV) infection starting a Darunavir/Ritonavir- or Efavirenz-based highly active antiretroviral therapy (HAART) regimen.
This is an ex-vivo study (study which takes place outside the organism and records immune
parameters from stored blood and cells of a defined population without any intervention by
the researcher) to evaluate the kinetics (study of the rate of change) of immune recovery
quality and function in stored plasma blood samples of treatment-naive (not previously
treated with antiretroviral drugs) patients with advanced human immunodeficiency virus (HIV)
infection starting a Darunavir/Ritonavir (DRV/r)- or Efavirenz (EFV)-based highly active
antiretroviral therapy (HAART) regimen. In previously stored plasma blood samples, the role
of DRV/r compared with EFV in reducing T-lymphocyte activation, DRV/r compared with EFV in
recovering T-lymphocyte immune phenotype in peripheral blood and thymic production, and
DRV/r compared with EFV in recovering T-lymphocyte function (functional immunity) will be
studied. Blood samples will be analyzed before (baseline) and up to 48 weeks after
initiating HAART.
Each patient will receive orally administered (given by mouth) regimens of either
Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina or Efavirenz (EFV) +
Tenofovir/Emtricitabina.
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Time Perspective: Retrospective