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OpenTrials
Completed

NCT Number: NCT01307124

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

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

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Key information

Conditions

HIV-Infected Children

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Srinagarind Hospital, Khon Kaen University, Khon Kaen, Changwat Khon Kaen, Thailand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV infection children age < 18 years old
  • Currently on PI regimens
  • HIV RNA viral load < 50 copies/ml at screening
  • BW 25-50 kg
  • Written informed consent

Exclusion criteria

  • Relevant history or current condition of PI resistance, plasma HIV RNA > 1000 copies/ml after received the PI regimens for at least 6 months
  • On rifampin, nevirapine, efavirenz which have drug interaction with lopinavir
  • On double boosted protease inhibitors

Treatment and study plan

Kaletra

Drug

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

Primary outcomes

  1. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Bamrasnaradura Infectious Diseases Institute
  • Buddhachinaraj Hospital
  • Chulalongkorn University
  • Nakornping Hospital
  • Phrachomklao Hospital
  • Prapokklao Hospital
  • Queen Sirikit National Institute of Child Health
  • Sappasitthiprasong Hospital
  • Srinagarind Hospital, Khon Kaen University
  • Surin Hospital
  • UdonThani Hospital

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 2, 2011
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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