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

NCT01307124 Phase 3 COMPLETED

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

Details

Lead sponsor	The HIV Netherlands Australia Thailand Research Collaboration
Phase	Phase 3
Status	COMPLETED
Enrolment	199
Start date	2011-03
Completion	2013-04

Conditions

• HIV-infected Children

Interventions

• kaletra

Primary outcomes

• 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 — 48 week
  proportion of patient who had HIV RNA \< 50 copies/ml Safety issue: patient who had HIV RNA \> 50 copies/ml during the study period will be checked for LPV blood level, if the LPV Cmin \< 1 ug/ml. The dose of LPV/r will be adjusted to appropriate dose.

Countries

Thailand