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Dose Reduction of Lopinavir in Children

NCT00887120 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-07-17

No results posted yet for this study

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

Conditions

  • HIV Infections

Interventions

DRUG

Lopinavir/ritonavir standard dose According to WHO simplified dosing table

* 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)

DRUG

Lopinavir/ritonavir low dose ( 70% of WHO recommended dosing table)

* 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)

Sponsors & Collaborators

  • Ministry of Education, Thailand

    collaborator OTHER

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Kiat Ruxrungtham, MD · Department of Medicine, Faculty of Medicine, Chulalongkorn University and Thai Red Cross Aids Research Centre - HIV-NAT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00887120 on ClinicalTrials.gov