An observational study in Human Immunodeficiency Virus; HIV, sponsored by Janssen-Cilag S.p.A.. Completed. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-11-26.
Sponsored by Janssen-Cilag S.p.A. · Observational
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 33 is below the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Janssen-Cilag S.p.A. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Antiretroviral treatment-naive patients with advanced HIV infection starting a Darunavir/Ritonavir - or Efavirenz-based HAART regimen. Patients with advanced HIV infection are defined by a treatment-naïve CD4+ cell count >50 to \<250 cells/mm3.
Exclusion Criteria is not defined in protocol.
Drug: Darunavir/Ritonavir (DRV/r)
Drug: Efavirenz (EFV)
Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen
Efavirenz (EFV) + Tenofovir/Emtricitabina regimen
Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells
Time frame: Baseline and Week 24
Change (>=10%) in the proportion of activated HLA-DR+CD38+CD8+ T-cells
Time frame: Baseline, Week 12, and Week 48
Change in peripheral T-lymphocyte immune phenotype
Time frame: Baseline, Week 12, Week 24 and Week 48
Change in peripheral T-lymphocyte turnover
Time frame: Baseline, Week 12, Week 24 and Week 48
No study locations are listed for this record.
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome→
Janssen-Cilag S.p.A.