HIVNAT 203: NAFLD study
Study title
Nonalcoholic fatty liver disease and long-term metabolic complications among perinatal HIV-infected children and adolescents receiving antiretroviral therapy
Study Code
HIVNAT 203: NAFLD study
Network
HIVNAT
Study PI
Tavitiya Sudjaritruk, MD, ScM
Study Co PI
Prof. Virat Sirisanthana, M.D.
Linda Aurpibul, M.D.
Study sites
Thailand
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), The Thai Red Cross AIDS Research Centre, Bangkok
- Faculty of Medicine Srinakarin Hospital, Khon Kaen University, Khon Kaen
- Faculty of Medicine and Research Institutes for Health Sciences, Chiang Mai University, Chiang Mai
Indonesia
Cipto Mangunkusumo Hospital, Jakarta
Funding agency
The NIH IeDEA program, through funds provided from NICHD
Study design
An age-matched case-control study. Cases and controls will be matched by their current age (+ 12 months) with the ratio of 1 case : 1 control.
Study objective
Aim 1: To compare the prevalence of NAFLD among perinatally HIV-infected children and adolescents with abnormal LFT while receiving successful ART with the prevalence of those with normal LFT.
Aim 2: To determine significant risk factors of NAFLD among perinatally HIV-infected children and adolescents receiving successful ART.
AIM 3: To assess the accuracy (sensitivity and specificity) of serum biomarkers for hepatic fibrosis and the correlation of the markers with transient elastography in diagnosis of hepatic fibrosis.
Aim 4: To identify the prevalence of MS among perinatally HIV-infected children and adolescents receiving successful ART.
Aim 5: To determine significant risk factors of MS among perinatally HIV-infected children and adolescents receiving successful ART.
Number of enrolled participants (overall/at RIHES)
120 perinatally HIV-infected children and adolescents from 4 participating sites.
For Faculty of Medicine and Research Institutes for Health Sciences (RIHES), Chiang Mai University will enroll approximately 20-25 perinatally HIV-infected children and adolescents to the study.
Year: started
January 2014
Year: expected to finish
December 2015
Significance
Nonalcoholic fatty liver disease (NAFLD) and Metabolic syndrome (MS) in HIV-infected children and adolescents receiving ART are considered as one of the critical research questions in pediatric HIV/AIDS field requiring specific and in-depth investigations. This proposed study will provide significant knowledge and better understanding about the burden and risk factors of NAFLD and MS in ART-experienced HIV-infected children and adolescents, especially in resource-constrained countries in order to address and draw attention to severely irreversible long-term medical complications in children and adolescents who are growing up with HIV