Pharmacokinetics and Efficacy of Low- or Standard-dose of Lopinavir/Ritonavir (Kaletra®) in PI-naïve HIV-1 Infected Children

NCT00887120 Phase 2 COMPLETED

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

Details

Lead sponsor	The HIV Netherlands Australia Thailand Research Collaboration
Phase	Phase 2
Status	COMPLETED
Enrolment	24
Start date	2007-04
Completion	2009-02

Conditions

• HIV Infections

Interventions

• Lopinavir/ritonavir standard dose According to WHO simplified dosing table
• Lopinavir/ritonavir low dose ( 70% of WHO recommended dosing table)

Primary outcomes

• pharmacokinetics of standard vs low dose LPV/r — 4 weeks after start ART

Countries

Thailand