Dose Reduction of Lopinavir in Children

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborator: Ministry of Education, Thailand
• Treatments: Lamivudine; Lopinavir; Ritonavir; Zidovudine

Criteria

Inclusion Criteria:

• Age from 2- 18 years old

• Documented positive test for HIV-1 infection

• PI-naïve

• HIV RNA viral load > 1,000 copies

• Written informed consent

Exclusion Criteria:

• Active opportunistic infection

• Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.

• Use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir

• Pregnancy or lactating

• Inability to understand the nature and extent of the study and the procedures required.