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

The HIV Netherlands Australia Thailand Research Collaboration199 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

199

Conditions

HIV-infected Children

Interventions

kaletraDRUG

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

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. HIV infection children age \< 18 years old 2. Currently on PI regimens 3. HIV RNA viral load \< 50 copies/ml at screening 4. BW 25-50 kg 5. Written informed consent Exclusion Criteria: 1. Relevant history or current condition of PI resistance, plasma HIV RNA \> 1000 copies/ml after received the PI regimens for at least 6 months 2. On rifampin, nevirapine, efavirenz which have drug interaction with lopinavir 3. On double boosted protease inhibitors

Locations (10)

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, Thailand

Bamrasnaradura Institute

Nonthaburi, Changwat Nonthaburi, Thailand

Queen Sirikit National Institute of Child Health

Bangkok, Thailand

Prapokklao Hospital

Outcomes

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

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.

Time frame: 48 week

Data from ClinicalTrials.gov

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