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

Phase 3

Completed

• Conditions: HIV-infected Children
• Interventions: Drug: kaletra

• Registration Number: NCT01307124
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-28
• Study Start: 2011-03
• Study First Posted: 2011-03-02
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
low dose	kaletra	Arm 2:Low dose BW 25-35 kg 200/50 mg BW \>35-50 kg 300/75 mg
standard dose	kaletra	Arm 1:LPV/r Standard dose BW 25-35 kg 300/75 mg BW \>35-50 kg 400/100 mg

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (10)

Queen Sirikit National Institute of Child Health; 🇹🇭 Bangkok, Thailand

Prapokklao Hospital; 🇹🇭 Chantaburi, Thailand

Nakornping Hospital; 🇹🇭 Chiang Mai, Thailand

Srinagarind Hospital, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand

Bamrasnaradura Institute; 🇹🇭 Nonthaburi, Thailand

Phrachomklao Hospital; 🇹🇭 Petchaburi, Thailand

Surin Hospital; 🇹🇭 Surin, Thailand

Sappasitthiprasong Hospital; 🇹🇭 Ubonratchathani, Thailand

Buddhachinaraj Hospital; 🇹🇭 Pitsanulok, Thailand

Udonthani Hospital; 🇹🇭 Udonthani, Thailand