NCT01307124

Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL)

A Multicenter Randomized Study to Compare the Safety and Efficacy of Low-dose Versus Standard Dose Lopinavir/Ritonavir Containing HAART Regimen in Virological Suppressed HIV-infected Thai Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load \< 50 copies/ml at 48 week

Conditions

• HIV-infected Children

Interventions

Type	Name	Description
DRUG	kaletra	The study participants will receive Lopinavir/ritonavir heat-stable tablet (100/25 mg or 200/50 mg) q 12 hour plus NRTIs. The other NRTIs is depend on physician discretion. Arm 1:LPV/r Standard dose Arm 2:Low dose BW 25-35 kg 300/75 mg 200/50 mg BW \>35-50 kg 400/100 mg 300/75 mg

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-03-02
• Last updated: 2015-03-25

Locations

10 sites across 1 country: Thailand