This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada.
It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
1, 400mg tablet twice a day, with Truvada 1 tablet once a day
2 tablets twice a day, with Truvada 1 tablet once a day
1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Absolute Change in CD4 Cell Counts
Time frame: 24 and 48 weeks
Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.
Time frame: 24 weeks
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