Third Line Highly Active Antiretroviral Therapy (HAART) in HIV-infected Children
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.
This Study is Designed to Collect Treatment Data of Thai Children on Third Line ARV Therapy.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Treatment Cohort of HIV-infected Children With Resistance or Intolerance to Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) First Line and PI Second Line Antiretroviral Therapy|
- undetectable viral load [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]Primary endpoint will be the proportions of subjects with HIV RNA below 400 and 50 copies/ml at 48 weeks.
- Hyperlipidemia [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]Number of subjects with hyperlipidemia as a measure of safety
Biospecimen Retention: Samples Without DNA
Plasma and PBMC
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Children who are already on third line ARV or are switching to third line ARV may be enrolled in this observational study
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225406
|Siriraj Hospital, Mahidol University|
|Bangkok, Thailand, 10700|
|Bangkok, Thailand, 10330|
|Bangkok, Thailand, 10330|
|Chantaburi, Thailand, 22000|
|Chiang Mai, Thailand, 50180|
|Chiang Rai Regional Hospital|
|Chiang Rai, Thailand, 57000|
|Khon Kaen University|
|Khon Kaen, Thailand, 40002|
|Nonthaburi, Thailand, 11000|
|Surin, Thailand, 32000|
|Principal Investigator:||Thanyawee Puthanakit, MD||Chulalongkorn University, Bangkok|
|Principal Investigator:||Kulkanya Chokephaibulkit, MD||Siriraj Hospital, Mahidol University, Bangkok, Thailand|