Dose Reduction of Lopinavir in Children

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

January 31, 2009

Study Completion Date

February 28, 2009

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)"

Trial Locations (1)

10330

HIV-NAT, Thai Red Cross AIDS Research Center, Bangkok, Bangkok

All Listed Sponsors
collaborator

Ministry of Education, Thailand

OTHER

lead

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

NCT00887120 - Dose Reduction of Lopinavir in Children | Biotech Hunter | Biotech Hunter