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OpenTrials
Completed

NCT Number: NCT01139905

Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children

To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.

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Key information

Conditions

HIV-1 Infections

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HIV-NAT

Bangkok, 10330, Thailand

About this study

This is an open-label, single arm study to compare standard dose with a new tablet formulation of a lower dose of lopinavir/ritonavir in HIV-1 infected children.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV infection
  • Age < 18 years old
  • BW > 25 kg
  • HIV RNA viral load < 50 copies within 6 months
  • Written informed consent

Exclusion criteria

  • Active opportunistic infection
  • Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
  • Use of concomitant medications that may interfere with the pharmacokinetics of lopinavir/ritonavir

Treatment and study plan

lopinavir/ritonavir

Other

standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.

Primary outcomes

  1. assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%)

    Time frame: 4 months

    study drug Aluvia (lopinavir/ritonavir 100/25 mg)

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Chulalongkorn University
  • Radboud University Medical Center

Registry information

Official study title

Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 9, 2010
Registry last updated
Mar 26, 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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