Pediatric and Youth Research Programs
There are 22 ongoing pediatric and youth studies (14 HIV-NAT initiated, 4 Collaborator-initiated, and 4 sponsor-initiated study). We also have more studies in adolescent including adherence project and HPV vaccination. We are having more publications from PREDICT substudies and early 2013 we will have result of PEARL study.
Even though our knowledge in the field of pediatric HIV has been increasing, yet there are still many unanswered questions because HIV treatment in infants and children differs from adults. New pediatric formulations continue to be lacking. Long-term effects of various drugs such as tenofovir are unknown. As these children grow older and become teenagers, other problems such as adherence and sexual transmitted infections become important. Drug resistance and effects that alter the basic blood profile such as increase in triglycerides and cholesterol are a constant battle among pediatricians taking care of these patients. Pediatric HIV continues to be challenging but fulfilling as we learn more about it.
PREDICT (Paediatric Randomized to Early vs Deferred Initiation in Cambodia and Thailand)
This is an open label, randomized phase III study comparing early versus deferred (starting HAART when CD4+ falls below 15%) initiation of HAART in anti-retroviral-naive children aged one to 12 years with CDC paediatric clinical classification category A or B and CD4+ between 15 to 24%. (NCT 00234091)
This sub study assesses the effect of immediate versus deferred antiretroviral initiation on neurodevelopment in children with HIV in Cambodia and Thailand. Neurodevelopment is assessed every six months. The primary outcome is the neurodevelopment functions in the immediate arm compared to the deferred arm at week 144.
This sub-study assesses the impact of selenium/zinc levels on HIV disease and treatment response in children.
PREDICT sub study- PREDICT Cohort
Extension for HIV-NAT 035
PREDICT Neuro Control group
The neurodevelopment in normal children in Cambodia and Thailand
This is a long term follow-up study assessing whether children with HIV infection undergoing planned ART interruptions are disadvantaged clinically, immunologically, virologically or neurologically from periods of time off ART.
Treatment response of chronic viral hepatitis B to tenofovir and lamivudine-containing antiretroviral regimen in HIV-infected adolescents with chronic hepatitis B co-infection; HBV-HIV adolescent cohort
This study will investigate the treatment of HBV-co infection in HIV-infected children.
An Open-label Study of Liquid and Sprinkled Formulations of Efavirenz Administered in Combination with Didanosine and Emtricitabine in HIV-infected Infants and Children 3 months to 6 years of Age (AI266922)
This study will evaluate the pharmacokinetic and efficacy of efavirenz in HIV-infected children.
PAINT (TMC 278-C213)
This is a phase II, open label, single arm multicenter trial evaluating the pharmacokinetics, safety, tolerability and antiviral activity of Rilpivirine (TMC 278-C213) in naive HIV-infected adolescents between the ages of 12 and 18 years.
Meaning of life in Thai HIV infected youth
This is a randomized control trial. This study will evaluate the effect of logotherapy in HIV infected youths.
This is a phase II, open-label multicenter trial evaluating the safety, tolerability and antiviral activity of Etravirine (TMC 125-C213) in treatment experienced HIV-infected children and adolescents.
Third line HAART in HIV-infected children
This study will assess efficacy and safety of third line regimen in 150 Thai children.
MRI brain in Children
This is a prospective study that will compare the total brain volume between HIV-infected and healthy children by using multimodal imaging approach such as tensor-based morphometry (TBM) and diffusion tensor imaging (DTI).
A Kaletra ONCE daily Randomized Trial of the pharmacokinetics, safety and efficacy of twice-daily versus once-daily lopinavir/ritonavir tablets dosed by weight as part of combination antiretroviral therapy in HIV-1 infected children
This study will evaluate once daily lopinavir/ritonavir-based HAART in virological suppressed children.
The objective of this study is to determine the efficacy of TDF-based regimen in HIV-infected Thai children and assess effect of TDF on renal problem and bone mineral density.
The objectives of this study is to compare the prevalence of HPV infection among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIV-negative adolescents, and compare the prevalence of intraepithelial neoplasia and presence of E6/E7 biomarker at cervical and anal sites among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIV-negative adolescents.
Short-Cycle Therapy (SCT) (5 days on/2 days off) in young people with chronic HIV-infection
This study will evaluate the efficacy and safety of short cycle therapy in HIV-infected children.
TASER-Pediatrics: Prospective Monitoring of Second-line Antiretroviral Therapy Failure and Resistance in Children
The PEARL study
Pediatric study for Appropriate dose of Ritonavir boosted Lopinavir in Thai HIV-infected children
This is a multicenter randomized study to compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppressed HIV-infected Thai children.
Improving Adherence in Adolescents
Randomised Trial Comparing Two Interventions to Improve Adherence to Combination Antiretroviral Therapy (cART) in Adolescents and Young Adults with HIV in Thailand
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The HIV Netherlands Australia Thailand Research Collaboration