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
Year: 2012
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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 (<50 copies/ml) on sHAART were randomized (2:1) to lopinavir/ritonavir (LPV/r) 400/100 mg BID+raltegravir (RAL) 400 mg BID switch (LPV-r/RAL arm) or to continue on sHAART. The primary endpoint was the proportion of subjects with HIV-RNA<50 copies/ml at week 48. Secondary efficacy and immunologic and safety endpoints were evaluated. Demographics and baseline lipid profile were similar across arms. Mean entry CD4 T cell count was 493 cells/mm(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-RNA<50 copies/ml (p=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.
Institutions: Emory University, Abbott (United States)
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: U.S. Department of Veterans Affairs, Emory University, Atlanta Clinical and Translational Science Institute, National Institutes of Health, U.S. Public Health Service, Center for AIDS Research, University of Washington, National Institute on Aging, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Center for Research Resources, National Center for Advancing Translational Sciences
Awards: Atlanta Clinical and Translational Science Institute (UL1), G1616360476, G1779015823, G179581801, G1913134163, Emory R38 Research Training Program, Emory WIHS CRS - Longitudinal Cohort, G2675028044, G3548165356, G4103619991, Effect of HIV Infection and HAART on Bone Homeostasis, Bone Loss and Immune Reconstitution in HIV/AIDS, Atlanta Clinical and Translational Science Institute (ACTSI) Renewal, GENERAL CLINICAL RESEARCH CENTER, G6113675784, G9000034708, Emory Specialized Center of Research Excellence (SCORE) on Sex Differences, Center for AIDS Research at Emory University
OpenAlex ID: W2051819166