NCT01196195

KONCERT A Kaletra ONCE Daily Randomised Trial of the Pharmacokinetics, Safety and Efficacy of Twice-daily Versus Once-daily Lopinavir/Ritonavir Tablets Dosed by Weight as Part of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-1 (HIV-1) Infected Children (PENTA 18)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: PENTA Foundation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The trial will evaluate the pharmacokinetics, safety, efficacy and acceptability of twice- and once-daily dosing of lopinavir/ritonavir tablets (Kaletra) dosed by weight in HIV-1 infected children who are currently taking lopinavir/ritonavir as part of their combination antiretroviral therapy and who are currently achieving virological suppression (\<50 copies/ml). Specifically: * To confirm weight-based dosing recommendations by evaluating the pharmacokinetics of twice-daily lopinavir/ritonavir half strength formulation tablets dosed on body weight and comparing to historical adult and paediatric data of pharmacokinetics of lopinavir/ritonavir soft gel capsules and oral solution respectively (1, 2). * To compare the pharmacokinetics of twice-daily lopinavir/ritonavir tablets with once-daily dosing in the same children. * To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression at 48 weeks. Adherence and acceptability will also be compared.

Conditions

• Antiretroviral Therapy in HIV-1 Infected Children

Interventions

Type	Name	Description
DRUG	Kaletra dosed once daily	Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = once daily.
DRUG	kaletra dosed twice daily	Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = twice daily.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-07-01
• Completion: 2013-08-01
• First posted: 2010-09-08
• Last updated: 2013-10-28

Locations

17 sites across 5 countries: Germany, Ireland, Netherlands, Thailand, United Kingdom