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Common TitleCASTLE
Official Title A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects
Phase Phase III
ClinicalTrials.gov NCT00272779
Treatments
Atazanavir
Atazanavir Reyataz

Atazanavir

Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)
,
Lopinavir-Ritonavir
Lopinavir-Ritonavir Kaletra

Lopinavir-Ritonavir

Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)
,
Ritonavir
Ritonavir Norvir

Ritonavir

Tradename:NorvirOther Names:RTVClass:Pharmacokinetic Enhancers
Categories Resistance/Virological FailureTreatment-NaivePharmacologyAdverse EffectsPregnancy/WomenGeneral Pharmacology
Funding
IndustryBristol-Myers Squibb
References
  • Lataillade M, Chiarella J, Yang R, et al. Prevalence and clinical significance of HIV drug resistance mutations by ultra-deep sequencing in antiretroviral-naïve subjects in the CASTLE study. PLoS One. 2010;5:e10952.
    [PubMed Abstract]
  • Malan N, Su J, Mancini M, et al. Gastrointestinal tolerability and quality of life in antiretroviral-naive HIV-1-infected patients: data from the CASTLE study. AIDS Care. 2010;22:677-86.
    [PubMed Abstract]
  • McDonald C, Uy J, Hu W, et al. Clinical significance of hyperbilirubinemia among HIV-1-infected patients treated with atazanavir/ritonavir through 96 weeks in the CASTLE study. AIDS Patient Care STDS. 2012;26:259-64.
    [PubMed Abstract]
  • Molina JM, Andrade-Villanueva J, Echevarria J, et al. Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr. 2010;53:323-32.
    [PubMed Abstract]
  • Molina JM, Andrade-Villanueva J, Echevarria J, et al. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet. 2008;372(9639):646-55.
    [PubMed Abstract]
  • Moyle G, Hardy H, Uy J, et al. Changes in biomarkers in HIV-1-infected treatment-naive patients treated with tenofovir DF/emtricitabine plus atazanavir/ritonavir or lopinavir/ritonavir for 96 weeks: the CASTLE biomarker substudy. Antivir Ther. 2014;19:693-9.
    [PubMed Abstract]
  • Moyle GJ, Hardy H, Farajallah A, DeGrosky M, McGrath D. Comparison of body composition changes between atazanavir/ritonavir and lopinavir/ritonavir each in combination with tenofovir/emtricitabine in antiretroviral-naïve patients with HIV-1 infection. Clin Drug Investig. 2014;34:287-96.
    [PubMed Abstract]
  • Moyle GJ, Hardy H, Farajallah A, McGrath SJ, Kaplita S, Ward D. Changes in bone mineral density after 96 weeks of treatment with atazanavir/ritonavir or lopinavir/ritonavir plus tenofovir DF/emtricitabine in treatment-naive patients with HIV-1 infection: the CASTLE body composition substudy. J Acquir Immune Defic Syndr. 2015;68:40-5.
    [PubMed Abstract]
  • Squires KE, Johnson M, Yang R, et al. Comparative gender analysis of the efficacy and safety of atazanavir/ritonavir and lopinavir/ritonavir at 96 weeks in the CASTLE study. J Antimicrob Chemother. 2011;66:363-70.
    [PubMed Abstract]
  • Zhu L, Liao S, Child M, et al. Pharmacokinetics and inhibitory quotient of atazanavir/ritonavir versus lopinavir/ritonavir in HIV-infected, treatment-naive patients who participated in the CASTLE Study. J Antimicrob Chemother. 2012;67:465-8.
    [PubMed Abstract]

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