Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
A prospective, randomized, open-label pilot study to assess virologic suppression and
immunologic recovery associated with a two-drug antiretroviral regimen of Raltegravir and the
protease inhibitor lopinavir/ritonavir (LPV/r) and a three drug regimen with Raltegravir and
two nRTIs (emtricitabine/tenofovir) in HIV-1 infected treatment-naïve subjects.
Immunology Substudy added to determine the kinetics of recovery of CD4 T cells and
subpopulations (regulatory T cell [T regs], TH-17 and TH1) after treatment initiation with
Raltegravir based regimens and their relationship with functional CD8 T cells and if
Raltegravir containing therapies leads to decreases in markers of gut microbial translocation
and of cellular and soluble markers of immune activation.