Status:
COMPLETED
Lopinavir/Ritonavir Monotherapy in Children
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
Chulalongkorn University
Khon Kaen University
Conditions:
HIV Infections
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of lopinavir/ritonavir (LPV/r) monotherapy maintenance in Thai childre...
Detailed Description
The commonly used antiretroviral (ARV) regimen in the Thai National Access to Antiretroviral Program for People Living with HIV/AIDS is non-nucleoside reverse transcriptase (NNRTI) based HAART. Howeve...
Eligibility Criteria
Inclusion
- HIV infected children ages 2 to 18 years
- Treated with double boosted PIs during the last three months
- Two consecutive plasma HIV-RNA levels \< 50 copies/ml at least 3 months apart
- Willing to restart HAART with the same regimen as before enrollment, when indicated
- Signed written informed consent
Exclusion
- Active AIDS-defining disease at screening
- Pregnancy
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00626301
Start Date
November 1 2007
End Date
September 1 2009
Last Update
March 26 2015
Active Locations (3)
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1
Department of Pediatrics, Chulalongkorn University Hospital
Bangkok, Bangkok, Thailand, 10330
2
HIV-NAT
Bangkok, Bangkok, Thailand, 10330
3
Department of Pediatrics, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand