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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Chulalongkorn University
Queen Sirikit National Institute of Child Health
Srinagarind Hospital, Khon Kaen University
Bamrasnaradura Institute
Nakornping Hospital
Prapokklao Hospital
Surin Hospital
Sappasitthiprasong Hospital
Udonthani Hospital
Buddhachinaraj Hospital
Phrachomklao Hospital
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01307124
First received: February 3, 2011
Last updated: July 24, 2012
Last verified: July 2012
History of Changes

February 3, 2011
July 24, 2012
March 2011
March 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01307124 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-infected Children
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
  • Active Comparator: standard dose
    Arm 1:LPV/r Standard dose BW 25-35 kg 300/75 mg BW >35-50 kg 400/100 mg
    Intervention: Drug: kaletra
  • Experimental: low dose
    Arm 2:Low dose BW 25-35 kg 200/50 mg BW >35-50 kg 300/75 mg
    Intervention: Drug: kaletra
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
June 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01307124
HIV-NAT 152
Yes
Thanyawee Puthanakit, Department of Pediatric , Faculty of Medicine, Chulalongkorn University and Thai Red Cross AIDS Research Centre - HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
  • Chulalongkorn University
  • Queen Sirikit National Institute of Child Health
  • Srinagarind Hospital, Khon Kaen University
  • Bamrasnaradura Institute
  • Nakornping Hospital
  • Prapokklao Hospital
  • Surin Hospital
  • Sappasitthiprasong Hospital
  • Udonthani Hospital
  • Buddhachinaraj Hospital
  • Phrachomklao Hospital
Principal Investigator: Thanyawee Puthanakit, MD Department of Pediatric , Faculty of Medicine, Chulalongkorn University and Thai Red Cross AIDS Research Centre - HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP