HIV Infections Clinical Trial
Official title:
A Pilot Study to Assess Virologic Suppression and Immune Recovery With Raltegravir and Lopinavir/Ritonavir and Raltegravir and Emtricitabine/Tenofovir in HIV-1 Infected Treatment-naïve Subjects
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.
A009 is a prospective, randomized, open-label pilot study to assess virologic suppression
and immune recovery rates associated with a two-drug potent antiretroviral regimen of
raltegravir and the protease inhibitor lopinavir/ritonavir and a three-drug regimen with
raltegravir and two nRTIs (emtricitabine/tenofovir) in treatment-naïve subjects.
HIV-1-infected subjects who are antiretroviral drug-naïve and have plasma HIV-1 RNA levels
≥5000 copies/ml obtained within 30 days prior to study entry will be randomized 1:1 to
Raltegravir 400 mg BID + LPV 400 mg/RTV 100 mg BID (Arm A) or Raltegravir 400 mg BID + FTC
200 mg/TDF 300 mg QD (Arm B).
Subjects will have measurements of HIV-1 RNA and CD4+ and CD8+ T-cell counts at pre-entry
and entry. The average of these measurements will be used to establish their baseline
values. Following entry, subjects will have plasma HIV-1 RNA samples drawn at days 2, 4, 8
and at weeks 2, 4, 8, 16, 24, 32, 40 and 48 and at virologic failure. CD38 expression on
CD4+/CD8+ cells and CD38/HLA-DR activation antigen on CD4+ and CD8+ cells and subsets T-cell
percentage will be done at entry, day 8 and weeks 4, 8, 24 and at virologic failure by
advanced flow cytometry.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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