Status:
COMPLETED
Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
Ministry of Education, Thailand
National Health Security Office, Thailand
Conditions:
This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy
Eligibility:
All Genders
Up to 18 years
Brief Summary
This is an observational cohort study of virologic and immunologic outcome after at least 48 weeks of third line antiretroviral therapy. Upto 150 children at 8 Thai sites will be enrolled. Third line ...
Detailed Description
The primary objective of this study is to assess the virological efficacy, as measured by the proportions of children with HIV RNA below 400 and 50 copies/ml at 48 weeks after initiating third line AR...
Eligibility Criteria
Inclusion
- Children (\< 18 years old) with HIV infection may enroll if one of the following criteria is met:
- Have resistance to at least one drug in each of the 3 classes (NRTI, NNRTI and PI) and have plasma HIV RNA \> 1000 copies/ml prior to switching to third line ARV therapy
- Have intolerance to the current NRTI, NNRTI or PI treatment and need to receive darunavir, etravirine, tipranavir or raltegravir
Exclusion
- Have hepatic impairment with ALT ≥ 5 upper limit of normal
- Pregnant or breastfeeding
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01225406
Start Date
August 1 2010
End Date
December 1 2013
Last Update
July 17 2020
Active Locations (9)
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1
Prapokklao Chantaburi
Chanthaburi, Changwat Chanthaburi, Thailand, 22000
2
Chulalongkorn University
Bangkok, Thailand, 10330
3
HIV-NAT
Bangkok, Thailand, 10330
4
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700