Status:
COMPLETED
Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
Chulalongkorn University
Radboud University Medical Center
Conditions:
HIV-1 Infections
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
Brief Summary
To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.
Detailed Description
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.
Eligibility Criteria
Inclusion
- HIV infection
- Age \< 18 years old
- BW \> 25 kg
- HIV RNA viral load \< 50 copies within 6 months
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01139905
Start Date
April 1 2010
End Date
March 1 2011
Last Update
March 26 2015
Active Locations (1)
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1
HIV-NAT
Bangkok, Thailand, 10330