A Switch in Therapy to a Reverse Transcriptase Inhibitor Sparing Combination of Lopinavir/Ritonavir and Raltegravir in Virologically Suppressed HIV-Infected Patients: A Pilot Randomized Trial to Assess Efficacy and Safety Profile: The KITE Study

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Abstract
A nucleoside reverse transcriptase inhibitor (NRTI) backbone is a recommended component of standard highly active antiretroviral therapy (sHAART). However, long-term NRTI exposure can be limited by toxicities. NRTI class-sparing alternatives are warranted in select patient populations. This is a 48-week single-center, open-label pilot study in which 60 HIV-infected adults with plasma HIV-1 RNA (3 . At week 48, 92% [95% confidence interval (CI): 83–100%] of the LPV-r/RAL arm and 88% (95% CI: 75–100%) of the sHAART arm had HIV-RNAp =0.70). Lipid profile (mean±SEM, mg/dl, LPV-r/RAL vs. sHAART) at week 24 was total-cholesterol 194±5 vs. 176±9 ( p =0.07), triglycerides 234±30 vs. 133±27 ( p =0.003), and LDL-cholesterol 121±6 vs. 110±8 ( p =0.27). There were no serious adverse events (AEs) in either arm. Regimen change occurred in three LPV-r/RAL subjects ( n =1, due to LPV-r/RAL-related AEs) vs. 0 in sHAART. There were no differences between arms in bone mineral density, total body fat composition, creatinine clearance, or CD4 T cell counts at week 48. In virologically suppressed patients on HAART, switching therapy to the NRTI-sparing LPV-r/RAL combination produced similar sustained virologic suppression and immunologic profile as sHAART. AEs were comparable between arms, but the LPV-r/RAL arm experienced higher triglyceridemia.

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