Antiretroviral Therapy in HIV-1 Infected Children Clinical Trial
Official title:
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)
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.
n/a