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Common TitleMONARK
Official Title A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen Versus Lopinavir/Ritonavir in Combination With Lamivudine/Zidovudine in Antiretroviral Naïve Patients
Phase Phase III
ClinicalTrials.gov NCT00234923
Treatments
Lopinavir-Ritonavir
Lopinavir-Ritonavir Kaletra

Lopinavir-Ritonavir

Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)
Categories Treatment-NaiveMonotherapyResistance/Virological FailurePharmacologyAdverse Effects
Funding
IndustryAbbott
References
  • Avettand-Fenoel V, Flandre P, Chaix ML, et al. Impact of 48 week lopinavir/ritonavir monotherapy on blood cell-associated HIV-1-DNA in the MONARK trial. J Antimicrob Chemother. 2010;65:1005-7.
    [PubMed Abstract]
  • Delaugerre C, Flandre P, Chaix ML, et al. Protease inhibitor resistance analysis in the MONARK trial comparing first-line lopinavir-ritonavir monotherapy to lopinavir-ritonavir plus zidovudine and lamivudine triple therapy. Antimicrob Agents Chemother. 2009;53:2934-9.
    [PubMed Abstract]
  • Delfraissy JF, Flandre P, Delaugerre C, et al. Lopinavir/ritonavir monotherapy or plus zidovudine and lamivudine in antiretroviral-naive HIV-infected patients. AIDS. 2008;22:385-93.
    [PubMed Abstract]
  • Flandre P, Delaugerre C, Ghosn J, et al. Prognostic factors for virological response in antiretroviral therapy-naive patients in the MONARK Trial randomized to ritonavir-boosted lopinavir alone. Antivir Ther. 2009;14:93-7.
    [PubMed Abstract]
  • Ghosn J, Flandre P, Cohen-Codar I, et al. Long-term (96-week) follow-up of antiretroviral-naïve HIV-infected patients treated with first-line lopinavir/ritonavir monotherapy in the MONARK trial. HIV Med. 2010;11:137-42.
    [PubMed Abstract]
  • Kolta S, Flandre P, Van PN, et al. Fat tissue distribution changes in HIV-infected patients treated with lopinavir/ritonavir. Results of the MONARK trial. Curr HIV Res. 2011;9:31-9.
    [PubMed Abstract]
  • Spire B, Marcellin F, Cohen-Codar I, et al. Effect of lopinavir/ritonavir monotherapy on quality of life and self-reported symptoms among antiretroviral-naive patients: results of the MONARK trial. Antivir Ther. 2008;13:591-9.
    [PubMed Abstract]
  • Tran TA, Ghosn J, Avettand-Fenoël V, et al. Residual HIV-1 replication may impact immune recovery in patients on first-line lopinavir/ritonavir monotherapy. J Antimicrob Chemother. 2015;70:2627-31.
    [PubMed Abstract]

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