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 antiretroviral therapy in this study is defined as an antiretroviral (ARV) regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir The knowledge gained from this study will help the Thai government in planning its strategy to provide third line ARV therapy to children within the national program.
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 ARV therapy. Third line ARV therapy is defined as an ARV regimen in a patient who has failure or intolerance to first line NNRTI-based therapy and second line PI-based therapy. Such regimens may contain new drugs or drug classes such as darunavir, tipranavir, etravirine and raltegravir
Study Type
OBSERVATIONAL
Enrollment
56
Prapokklao Chantaburi
Chanthaburi, Changwat Chanthaburi, Thailand
Chulalongkorn University
Bangkok, Thailand
HIV-NAT
Bangkok, Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand
Nakornping Hospital
Chiang Mai, Thailand
Chiang Rai Regional Hospital
Chiang Rai, Thailand
Khon Kaen University
Khon Kaen, Thailand
Bamrasnaradura Institute
Nonthaburi, Thailand
Surin Hospital
Surin, Thailand
undetectable viral load
Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml at 48 weeks.
Time frame: 48 weeks
Hyperlipidemia
Number of subjects with hyperlipidemia as a measure of safety
Time frame: 48 weeks
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