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

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 Overview

• Status: Completed
• Conditions: HIV-infected Children
• Intervention / Treatment: Drug: kaletra

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Queen Sirikit National Institute of Child Health
  • Chantaburi, Thailand
    • Prapokklao Hospital
  • Chiang Mai, Thailand
    • Nakornping Hospital
  • Khon Kaen, Thailand
    • Srinagarind Hospital, Khon Kaen University
  • Nonthaburi, Thailand, 11000
    • Bamrasnaradura Institute
  • Petchaburi, Thailand
    • Phrachomklao Hospital
  • Pitsanulok, Thailand
    • Buddhachinaraj Hospital
  • Surin, Thailand
    • Surin Hospital
  • Ubonratchathani, Thailand
    • Sappasitthiprasong Hospital
  • Udonthani, Thailand
    • UdonThani Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: standard dose; Arm 1:LPV/r Standard dose BW 25-35 kg 300/75 mg BW >35-50 kg 400/100 mg	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
EXPERIMENTAL: low dose; Arm 2:Low dose BW 25-35 kg 200/50 mg BW >35-50 kg 300/75 mg	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 week

Collaborators and Investigators

• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Chulalongkorn University; Queen Sirikit National Institute of Child Health; Srinagarind Hospital, Khon Kaen University; Bamrasnaradura Infectious Diseases Institute; Nakornping Hospital; Prapokklao Hospital; Surin Hospital; Sappasitthiprasong Hospital; UdonThani Hospital; Buddhachinaraj Hospital; Phrachomklao Hospital
• Investigators: Principal Investigator: Thanyawee Puthanakit, MD, Department of Pediatric , Faculty of Medicine, Chulalongkorn University and Thai Red Cross AIDS Research Centre - HIV-NAT

Publications and helpful links

General Publications

• A randomized study comparing low dose versus standard dose lopinavir/ritonavir among HIV-infected children with virological suppression . Presented at 7th IAS 2013 in June 30-July 3, 2013 in Kuala Lumpur, Malaysia as abstract presentation.
• Association of SCLO1B1 polymorphism and plasma concentration of lopinavir in HIV-infected children. Presented at 7th IAS 2013 in June 30-July 3, 2013 in Kuala Lumpur, Malaysia as abstract presentation and 5th International Workshop on HIV Pediatrics in June 28-29, 2013 in Kuala Lumpur, Malaysia

Helpful Links

• HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: February 3, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (ESTIMATE): March 2, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: HIV infected children; safety and efficacy; low dose LPV/r; standard dose LPV/r
• Other Study ID Numbers: HIV-NAT 152