Abstract
Methods Study drugs were dosed for three days to achieve maximal exposure, as RTV-mediated CYP3A4 inhibition is complete and induction is minimal at Day 3. LPV/r was administered at 400/100 mg BID and at supratherapeutic dose of 800/200 mg BID. RTV was dosed at 400 mg BID. Digital EKGs were performed in triplicate on Study Day 3 and compared to time-matched baseline. No effect on QTcF was concluded if the 95% upper confidence bound for the difference of drug mean from placebo mean was less than 10 msec for all times of measurement (Per ICH Guidance). Pharmacokinetic samples were obtained and exposure and QTcF relationship was analyzed.
Highlights
Abstracts of the Ninth International Congress on Drug Therapy in HIV Infection Meeting abstracts – A single PDF containing all abstracts in this Supplement is available here. http://www.biomedcentral.com/content/pdf/1758-2652-11-S1-info.pdf
LPV/r was administered at 400/100 mg BID and at supratherapeutic dose of 800/200 mg BID
Digital EKGs were performed in triplicate on Study Day 3 and compared to time-matched baseline
Summary
Evaluation of the impact of lopinavir/ritonavir (LPV/r) and ritonavir (RTV) on QTcF: results of a thorough QT study. CE Klein*, YL Chiu, BA Da Silva, PA Noertersheuser, WM Awni, CM Holas, TT Doan and B Bernstein. Address: Abbott, Abbott Park, USA * Corresponding author from Ninth International Congress on Drug Therapy in HIV Infection Glasgow, UK. Published: 10 November 2008 Journal of the International AIDS Society 2008, 11(Suppl 1):P95 doi:10.1186/1758-2652-11-S1-P95. Abstracts of the Ninth International Congress on Drug Therapy in HIV Infection Meeting abstracts – A single PDF containing all abstracts in this Supplement is available here. http://www.biomedcentral.com/content/pdf/1758-2652-11-S1-info.pdf
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