FindTrial
Sign In

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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01307124
Enrollment
199
Registered
2011-03-02
Start date
2011-03-31
Completion date
2013-04-30
Last updated
2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-infected Children

Keywords

safety and efficacy, low dose LPV/r, standard dose LPV/r, HIV infected children

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

Interventions

DRUGkaletra

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

Sponsors

Chulalongkorn University
CollaboratorOTHER
Queen Sirikit National Institute of Child Health
CollaboratorOTHER_GOV
Srinagarind Hospital, Khon Kaen University
CollaboratorOTHER
Bamrasnaradura Infectious Diseases Institute
CollaboratorOTHER_GOV
Nakornping Hospital
CollaboratorOTHER
Prapokklao Hospital
CollaboratorUNKNOWN
Surin Hospital
CollaboratorUNKNOWN
Sappasitthiprasong Hospital
CollaboratorUNKNOWN
UdonThani Hospital
CollaboratorOTHER_GOV
Buddhachinaraj Hospital
CollaboratorOTHER
Phrachomklao Hospital
CollaboratorUNKNOWN
The HIV Netherlands Australia Thailand Research Collaboration
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 week48 weekproportion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026