NCT00887120|CompletedPhase 2
Dose Reduction of Lopinavir in Children
Pharmacokinetics and Efficacy of Low- or Standard-dose of Lopinavir/Ritonavir (Kaletra®) in PI-naïve HIV-1 Infected Children
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Pharmacokinetics and Efficacy of Low- or Standard-dose of Lopinavir/Ritonavir (Kaletra®) in PI-naïve HIV-1 Infected Children
Sponsor study identifier
interventional
24
1 country
1
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)Study Completion
February 2009
Actual (reported)To study the pharmacokinetics of low-dose and standard dose, lopinavir/ritonavir in ARV PI naive HIV-1 infected Thai children. To study clinical and immunological efficacy after 48 weeks of lopinavir/ritonavir in PI naïve HIV-1 infected Thai children
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
January 2009
Actual (reported)February 2009
Actual (reported)April 21, 2009
Actual (reported)April 23, 2009
Actual (reported)pharmacokinetics of standard vs low dose LPV/r
4 weeks after start ART
efficacy and safety of standard and low dose LPV/r
48 weeks
Lopinavir/ritonavir standard dose + zidovudine and lamivudine
Lopinavir/ritonavir low dose (70% of standard dose) + zidovudine and lamivudine
* BW 6-7.9 kg: 1.5 mL oral q 12 hr * BW 8.0-16.9 kg: 2.0 ml oral q 12 hr * BW 17.0-19.9 kg: 2.5 ml oral q 12 hr * BW 20.0 - 24.9 kg: 3.0 ml oral q 12 hr * BW 25.0 - 29.9 kg: 3.5 ml oral q 12 hr * BW 30.0-34.9 kg: 4.0 ml oral q 12 hr * BW \> 35 kg: 5.0 ml oral q 12 hr Dose of Zidovudine (AZT) is 180-240 mg/m2 per dose every 12 hours Dose of Lamivudine (3TC) is 4 mg/kg every 12 hours Dose of Lopinavir/ritonavir (LPV/r)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Lopinavir/ritonavir standard dose According to WHO simplified dosing table
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Lopinavir/ritonavir low dose ( 70% of WHO recommended dosing table)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordHIV-NAT, Thai Red Cross AIDS Research Center, Bangkok
Bangkok, 10330, Thailand
Puthanakit T, van der Lugt J, Bunupuradah T, Ananworanich J, Gorowara M, Phasomsap C, Jupimai T, Boonrak P, Pancharoen C, Burger D, Ruxrungtham K. Pharmacokinetics and 48 week efficacy of low-dose lopinavir/ritonavir in HIV-infected children. J Antimicrob Chemother. 2009 Nov;64(5):1080-6. doi: 10.1093/jac/dkp322. Epub 2009 Sep 2.
Kiat Ruxrungtham, MD
Department of Medicine, Faculty of Medicine, Chulalongkorn University and Thai Red Cross Aids Research Centre - HIV-NAT
24 participants (actual enrollment reported by the registry).
First Submitted
April 21, 2009
First Posted
April 23, 2009
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Pharmacokinetics of Low Dose Raltegravir
* BW 6-7.9 kg: 1.0 mL oral q 12 hr * BW 8.0-16.9 kg: 1.5 ml oral q 12 hr * BW 17.0-19.9 kg: 1.8 ml oral q 12 hr * BW 20.0 - 24.9 kg: 2.0 ml oral q 12 hr * BW 25.0 - 29.9 kg: 2.5 ml oral q 12 hr * BW 30.0-34.9 kg: 3.0 ml oral q 12 hr * BW \> 35 kg: 3.5 ml oral q 12 h Dose of Zidovudine (AZT) is 180-240 mg/m2 per dose every 12 hours Dose of Lamivudine (3TC) is 4 mg/kg every 12 hours Dose of Lopinavir/ritonavir (LPV/r)
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Primary Completion
January 2009
Actual (reported)Study Completion
February 2009
Actual (reported)Last Updated
July 17, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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