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

NCT01307124 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2015-03-25

No results posted yet for this study

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

Conditions

  • HIV-infected Children

Interventions

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

Sponsors & Collaborators

  • Chulalongkorn University

    collaborator OTHER

  • Queen Sirikit National Institute of Child Health

    collaborator OTHER_GOV

  • Srinagarind Hospital, Khon Kaen University

    collaborator OTHER

  • Bamrasnaradura Infectious Diseases Institute

    collaborator OTHER_GOV

  • Nakornping Hospital

    collaborator OTHER

  • Prapokklao Hospital

    collaborator UNKNOWN

  • Surin Hospital

    collaborator UNKNOWN

  • Sappasitthiprasong Hospital

    collaborator UNKNOWN

  • UdonThani Hospital

    collaborator OTHER_GOV

  • Buddhachinaraj Hospital

    collaborator OTHER

  • Phrachomklao Hospital

    collaborator UNKNOWN

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Thanyawee Puthanakit, MD · Department of Pediatric , Faculty of Medicine, Chulalongkorn University and Thai Red Cross AIDS Research Centre - HIV-NAT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01307124 on ClinicalTrials.gov