PMID- 22364141
OWN - NLM
STAT- MEDLINE
DCOM- 20130219
LR  - 20211021
IS  - 1931-8405 (Electronic)
IS  - 0889-2229 (Print)
IS  - 0889-2229 (Linking)
VI  - 28
IP  - 10
DP  - 2012 Oct
TI  - 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.
PG  - 1196-206
AB  - 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.
FAU - Ofotokun, Ighovwerha
AU  - Ofotokun I
AD  - Emory University School of Medicine, Department of Medicine, Division of 
      Infectious Diseases, Atlanta, Georgia 30303, USA. iofotok@emory.edu
FAU - Sheth, Anandi N
AU  - Sheth AN
FAU - Sanford, Sara E
AU  - Sanford SE
FAU - Easley, Kirk A
AU  - Easley KA
FAU - Shenvi, Neeta
AU  - Shenvi N
FAU - White, Kelly
AU  - White K
FAU - Eaton, Molly E
AU  - Eaton ME
FAU - Del Rio, Carlos
AU  - Del Rio C
FAU - Lennox, Jeffrey L
AU  - Lennox JL
LA  - eng
GR  - R38 AI140299/AI/NIAID NIH HHS/United States
GR  - U54 AG062334/AG/NIA NIH HHS/United States
GR  - K23 A1073119/PHS HHS/United States
GR  - R01 AR059364/AR/NIAMS NIH HHS/United States
GR  - MO1RR00039/RR/NCRR NIH HHS/United States
GR  - UL1 TR000454/TR/NCATS NIH HHS/United States
GR  - I01 BX000105/BX/BLRD VA/United States
GR  - P30 AI050409/AI/NIAID NIH HHS/United States
GR  - UL1 RR025008/RR/NCRR NIH HHS/United States
GR  - U01 AI103408/AI/NIAID NIH HHS/United States
GR  - R01 AG040013/AG/NIA NIH HHS/United States
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20120420
PL  - United States
TA  - AIDS Res Hum Retroviruses
JT  - AIDS research and human retroviruses
JID - 8709376
RN  - 0 (HIV Protease Inhibitors)
RN  - 0 (Lipids)
RN  - 0 (Pyrrolidinones)
RN  - 0 (RNA, Viral)
RN  - 2494G1JF75 (Lopinavir)
RN  - 43Y000U234 (Raltegravir Potassium)
RN  - O3J8G9O825 (Ritonavir)
SB  - IM
MH  - Acquired Immunodeficiency Syndrome/*drug therapy/immunology
MH  - CD4 Lymphocyte Count
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Follow-Up Studies
MH  - HIV Protease Inhibitors/*administration & dosage/pharmacology
MH  - *HIV-1
MH  - Humans
MH  - Lipids/immunology
MH  - Lopinavir/*administration & dosage/pharmacology
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Pyrrolidinones/*administration & dosage/pharmacology
MH  - RNA, Viral/immunology
MH  - Raltegravir Potassium
MH  - Ritonavir/*administration & dosage/pharmacology
MH  - Treatment Outcome
MH  - Viral Load
PMC - PMC3448110
EDAT- 2012/03/01 06:00
MHDA- 2013/02/21 06:00
PMCR- 2013/10/01
CRDT- 2012/02/28 06:00
PHST- 2012/02/28 06:00 [entrez]
PHST- 2012/03/01 06:00 [pubmed]
PHST- 2013/02/21 06:00 [medline]
PHST- 2013/10/01 00:00 [pmc-release]
AID - 10.1089/aid.2011.0336 [pii]
AID - 10.1089/AID.2011.0336 [doi]
PST - ppublish
SO  - AIDS Res Hum Retroviruses. 2012 Oct;28(10):1196-206. doi: 10.1089/AID.2011.0336. 
      Epub 2012 Apr 20.