Status:
COMPLETED
Dose Reduction of Lopinavir in Children
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
Ministry of Education, Thailand
Conditions:
HIV Infections
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
Brief Summary
To study the pharmacokinetics of low-dose and standard dose, lopinavir/ritonavir in ARV PI naive HIV-1 infected Thai children. To study clinical and immunological efficacy after 48 weeks of lopinavir...
Detailed Description
In 2002, the Thai Ministry of Public Health (MOPH) launched the National Access to Antiretroviral Program for People living with HIV/AIDS (NAPHA) with the aim of providing treatment to all Thai patien...
Eligibility Criteria
Inclusion
- Age from 2- 18 years old
- Documented positive test for HIV-1 infection
- PI-naïve
- HIV RNA viral load \> 1,000 copies
- 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 medication that may interfere with the pharmacokinetics of lopinavir/ritonavir
- Pregnancy or lactating
- Inability to understand the nature and extent of the study and the procedures required.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00887120
Start Date
April 1 2007
End Date
February 1 2009
Last Update
July 17 2020
Active Locations (1)
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1
HIV-NAT, Thai Red Cross AIDS Research Center, Bangkok
Bangkok, Thailand, 10330