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.

AIDS Research and Human Retroviruses
Ighovwerha OfotokunJeffrey L Lennox

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...Continue Reading

Associated Clinical Trials

Jun 18, 2008·Ighovwerha Ofotokun, Ighovwerha Ofotokun

References

Mar 29, 2003·Drugs·Risto S Cvetkovic, Karen L Goa
Feb 27, 2004·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Julio S G MontanerMichael V O'Shaughnessy
Jan 18, 2007·Annals of Internal Medicine·Nicolai LohseNiels Obel
Jun 27, 2007·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Kelem KassahunLarissa A Wenning
Jul 11, 2007·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Charlotte LewdenUNKNOWN Agence Nationale de Recherches sur le Sida et les Hepatites Virales (ANRS) CO3 AQUITAINE Study Group
Dec 14, 2007·Journal of Clinical Pharmacology·Marian IwamotoJohn A Wagner
Dec 14, 2007·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Nancy R ReynoldsMargaret A Chesney
Jul 3, 2008·JAMA : the Journal of the American Medical Association·Krishnan BhaskaranUNKNOWN CASCADE Collaboration
Jul 25, 2008·The New England Journal of Medicine·David A CooperUNKNOWN BENCHMRK Study Teams
Feb 24, 2009·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Charles Hicks, Roy M Gulick
Nov 18, 2009·Antimicrobial Agents and Chemotherapy·Elizabeth C ReumanRobert W Shafer
Jan 6, 2010·Current Opinion in HIV and AIDS·Anne-Genevieve MarcelinVincent Calvez
Jan 21, 2010·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Roy T SteigbigelUNKNOWN BENCHMRK Study Teamsa
Aug 3, 2010·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Ryan D CooperMarcello Tonelli
Aug 13, 2010·Expert Opinion on Drug Metabolism & Toxicology·David M Burger
Oct 16, 2010·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Rita MurriEnrica Tamburrini

❮ Previous
Next ❯

Citations

Sep 5, 2013·Drugs·Giovanni GuaraldiAntonella Santoro
Oct 26, 2013·The Lancet Infectious Diseases·Jordan E Lake, Judith S Currier
Jun 2, 2014·Current Infectious Disease Reports·Pola de la TorreJohn D Baxter
Feb 18, 2016·Drugs·Sean G KellyBabafemi O Taiwo
Nov 26, 2015·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Jan van LunzenPierre-Marie Girard
Apr 16, 2014·The Lancet. Diabetes & Endocrinology·Mark J BollandIan R Reid
Feb 26, 2016·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Franco MaggioloAnnapaola Callegaro
Jan 9, 2015·Infectious Diseases and Therapy·Corinne Isnard Bagnis, Hans-Jürgen Stellbrink
Sep 3, 2014·The Journal of Infectious Diseases·Katherine W KooijUNKNOWN AGEhIV Cohort Study group
Mar 16, 2016·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Maile Y KarrisUNKNOWN California Collaborative Treatment Group (CCTG) 589 Study Team
Sep 23, 2016·The Journal of Antimicrobial Chemotherapy·Vincent CalvezRoland Landman
Mar 31, 2017·AIDS·Christine KatlamaRobert L Murphy
Mar 18, 2017·BMC Infectious Diseases·Franco MaggioloCristina Mussini
Jun 18, 2017·Expert Opinion on Drug Safety·Vicente SorianoPablo Labarga
May 21, 2013·Respirology : Official Journal of the Asian Pacific Society of Respirology·Shui Shan LeeChi Chiu Leung
Feb 10, 2021·Expert Opinion on Drug Safety·Julen CadiñanosJose R Arribas

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Methods Mentioned

BETA
pregnancy
contraception

Clinical Trials Mentioned

NCT00700115

Software Mentioned

SAS Proc Genmod
SAS Proc Mixed

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