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

This study has been completed.
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 (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01307124
First received: February 3, 2011
Last updated: March 23, 2015
Last verified: March 2015
  Purpose

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


Condition Intervention Phase
HIV-infected Children
Drug: kaletra
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • 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.


Enrollment: 199
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307124

Locations
Thailand
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, 11000
Phrachomklao Hospital
Petchaburi, Thailand
Buddhachinaraj Hospital
Pitsanulok, Thailand
Surin Hospital
Surin, Thailand
Sappasitthiprasong Hospital
Ubonratchathani, Thailand
Udonthani Hospital
Udonthani, Thailand
Sponsors and Collaborators
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
Investigators
Principal Investigator: Thanyawee Puthanakit, MD Department of Pediatric , Faculty of Medicine, Chulalongkorn University and Thai Red Cross AIDS Research Centre - HIV-NAT
  More Information

Additional Information:
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

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01307124     History of Changes
Other Study ID Numbers: HIV-NAT 152
Study First Received: February 3, 2011
Last Updated: March 23, 2015
Health Authority: Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
safety and efficacy
low dose LPV/r
standard dose LPV/r
HIV infected children

Additional relevant MeSH terms:
Lopinavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 05, 2015