Studies
Pediatric and Youth Research Programs

HIV-NAT035.1

Study ID: HIV-NAT035.1
Sub-study of: PREDICT: Paediatric Randomized to Early vs Deferred Initiation in Cambodia and Thailand
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.
Status: Ongoing since Feb 2007. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 300/283 (HIV-NAT=23)

Bone-D Study

Study ID: HIV-NAT175
Bone health and vitamin D status among perinatally HIV-infected Asian children and adolescents with virological suppression. This is a multicenter, cross-sectional study that will determine the prevalence and associated factors of adverse bone health effect among perinatally HIV-infected Asian children and adolescents with virological suppression after receiving antiretroviral therapy (ART). The study will also assess the independent associations of vitamin D status with systemic inflammation and abnormal bone remodeling among these children and adolescents.
Status: Closed Feb 2015. Manuscript writing
Target/Enrolled: 140/120

CAL-D

Study ID: HIV-NAT225
Effect of calcium and high-dose vitamin D supplementation on bone mineral density among prenatally HIV-infected children and adolescents. This study is a multicenter, randomized, open-labeled, phase II clinical trial comparing the effect of a 48-week daily calcium and high-dose vitamin D supplementation to calcium plus normal dose vitamin D supplementation on bone mineral density (BMD) in perinatally HIV infected children and adolescents.
Status: Open June 2015. RIHES is the coordinating center for this study. Still recruiting participants
Target/Enrolled: 100/58
Collaborator: RIHES, Chiang Mai University and Nakornping Hospital

CHIVAS: Children with HIV and Asthma

Study ID: HIV-NAT102
This aims to study allergen specific T effector and T regulatory cell response in HIV-infected children before and after commencement of HAART.
Status: Closed 2015. Manuscript writing
Target/Enrolled: 20/16
Site: HIV-NAT

Determinants of Resilience in Youth with HIV infection and Youth affected by HIV

Study ID: HIV-NAT217
This is a prospective observational cohort study that will identify the determinants of resilience in HIV-infected youth from the PREDICT cohort, prenatally HIV-exposed/HIV-negative youth and HIV-unexposed/HIV-negative youth adolescents.
Status: Opened Jan 2015
Target/Enrolled: 602/403
Collaborator: Srinagarind Hospital, Khon Kean University; Queen SavangVadhana Memorial Hospital, Chonburi; Nakornping Hospital, Chiang Mai; Chiangrai Prachanukroh Hospital, Chiang Rai; Prapokklao Hospital, Chantaburi; RIHES; National Pediatric Hospital, Phnom Penh, Cambodia and the Social Health Clinic, Phnom Penh, Cambodia

Diet and exercise

Study ID: HIV-NAT179
Effects of promotion on dietary intake and exercise on attitudes and practices of HIV-infected children and adolescents. This is a prospective study to evaluate the transfer of knowledge on nutrition and exercise as well as its effects in HIV-infected children and adolescents.
Status: Closed 2015. Manuscript writing
Target/Enrolled: 60/58

HIV reservoir in early-treated children

Study ID: HIV-NAT194
This is a cross-sectional study of clinical data and blood sample collection for HIV reservoir and immunity determination.
Status: Ongoing
Target/Enrolled: 100 (7 sites)/42 (HIV-NAT=12)
Collaborator: King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand; Siriraj Hospital, Mahidol University, Bangkok, Thailand; Queen Sirikit National Institute of Child Health, Bangkok, Thailand; Faculty of Medicine Srinakarin Hospital, Khon Kaen University, Khon Kaen; Nakornping Hospital, Chiang Mai, Thailand; Hat Yai Hospital, Songkha, Thailand; ;VCI Chulalongkorn University; RIHES; The University of Montreal, Montreal, Canada;The US Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR), MD, USA; Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok, Thailand; The U.S. National Institutes of Health, MD, USA

HPV in adolescents

Study ID: HIV-NAT139
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.
Status: Closed Nov 2013. Data is being analyzed
Target/Enrolled: 60/60
Site: HIV-NAT, Petchburi Hospital, Siriraj Hospital and Chiangrai Prachanukroh Hospital
Result: At least one-third of perinatally and behaviorally HIV-infected adolescents had abnormal cytology and at least half had HPV infection and E6/E7 oncogenic mRNA. HIV positive adolescents need access to preventative HPV immunization and routine monitoring for pre-cancerous and cancerous changes.

Improving Adherence in Adolescents

Study ID: HIV-NAT171
Randomised Trial Comparing Two Interventions to Improve Adherence to Combination Antiretroviral Therapy (cART) in Adolescents and Young Adults with HIV in Thailand
Status: Closed May 2014
Target/Enrolled: 100/96 (HIV-NAT=25)
Collaborator: HIV-NAT, SEARCH children and youth program, We Understand Group, Khon Kaen University and AID Access Chiang Rai
Site: HIV-NAT, khon Kaen University, Phrachomklao Hospital, Petchaburi, Chaing Rai; Mae Chan Hospital, Phan Hospital, Mae Suai Hospital, Mae Sai Hospital, Phraya Meng Rai Hospital, Somdej Phra Yanna Sangworn Hospital and Thoeng Hospital

KONCERT/PENTA 18

Study ID: HIV-NAT124
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.
Status: Closed Jan 7, 2014
Target/Enrolled: 8/8

Liver and metabolic complications

Study ID: HIV-NAT203
Nonalcoholic fatty liver disease (NAFLD) and long-term metabolic complications among perinatal HIV-infected children and adolescents receiving antiretroviral therapy This is an age-matched case-control study that will evaluate the burden and associated risk factors of NAFLD and metabolic syndrome among perinatally HIV-infected children and adolescents receiving successful ART from resource-constrained countries, Thailand and Indonesia.
Status: Closed 2015
Target/Enrolled: 60/35

Meaning in life Thai HIV-infected youth

Study ID: HIV-NAT109
This is a randomized control trial To evaluate the effect of logotherapy in HIV infected youth.
Status: Closed 2015. Manuscript writing
Target/Enrolled: 48/48

MRI brain in children

Study ID: HIV-NAT121
Sub-study of: PREDICT: Paediatric Randomized to Early vs Deferred Initiation in Cambodia and Thailand
This is a prospective study to compare brain volumes and Diffusion Tensor Imaging (DTI) in HIV-infected children from the immediate compared to deferred antiretroviral therapy arms of PREDICT and to HIV-negative healthy children and teenage
Status: Closed June 2015
Target/Enrolled: 150/140
Collaborator: SEARCH; King Chulalongkorn Hospital, Chulalongkorn University; Srinagarind Hospital, Khon Kaen University; Chiang Mai Hospital, Chiang Mai University

PENTA 11

Study ID: HIV-NAT066
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.
Status: Closed Oct 2013
Target/Enrolled: 9/9

PREDICT Behavior Study

Study ID: HIV-NAT183
Sub-study of: PREDICT: Paediatric Randomized to Early vs Deferred Initiation in Cambodia and Thailand
This is a cross-sectional study of socioeconomic factors effect on cognition, adaptive function and school status in the PREDICT cohort
Status: Closed March 2016
Target/Enrolled: 600/543 (HIV-NAT=72)

PREDICT Cohort

Study ID: HIV-NAT035.3
Sub-study of: PREDICT: Paediatric Randomized to Early vs Deferred Initiation in Cambodia and Thailand
Extension for HIV-NAT 035
Status: Closed May 2014.
Target/Enrolled: 300/283 (HIV-NAT=24)
Collaborator: David A. Cooper
Site Pls: Bamrasnaradura Infectious Disease Institute: Jurai Wongsawat, Khon Kaen University: Pope Kosalaraksa, Queen Savang Vadhana Memorial Hospital: Wicharn Luesomboon, Nakornping Hospital: Suparat Kanjanavanit, Chiangrai Prachanukroh Hospital: Rawiwan Hansudewechakul, and Prapokklao Chantaburi: Chaiwat Ngampiyasakul; National Center for HIV/AIDS, Dermatology and STDs (NCHADS): Mean Chhi Vun and Vonthanak Saphonn

PREDICT: Paediatric Randomized to Early vs Deferred Initiation in Cambodia and Thailand

Study ID: HIV-NAT035
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%.
Status: Completed in 2011
Target/Enrolled: 180 Thai/120 Cambodian children
Collaborator: David A. Cooper
Site Pls: Bamrasnaradura Infectious Disease Institute: Jurai Wongsawat , Khon Kaen University: Pope Kosalaraksa, Queen Savang Vadhana Memorial Hospital: Wicharn Luesomboon, Nakornping Hospital: Suparat Kanjanavanit, Chiangrai Regional Hospital: Rawiwan Hansudewechakul, and Prapokklao Chantaburi: Chaiwat Ngampiyasakul; National Center for HIV/AIDS, Dermatology and STDs (NCHADS): Mean Chhi Vun and Vonthanak Saphonn

TApHOD ACASI

Study ID: HIV-NAT184
Understanding Adherence, Stigma, and Behavioral Risk Factors of Adolescents in the TREAT Asia Pediatric HIV Observational Database using an Audio Computer-Assisted Self Interview. This is a descriptive/qualitative study utilizing questionnaires, interviews and diaries to assess the antiretroviral therapy, risk factors, stigma, violence and sexual behaviors of the adolescents with and without HIV. Samples and specimens are collected too.
Status: Closed June 2016
Target/Enrolled: 310/310 (HIV-NAT=48)

TASER-P

Study ID: HIV-NAT149
TASER-Pediatrics: Prospective Monitoring of Second-line Antiretroviral Therapy Failure and Resistance in Children. This is multicenter, observational cohort study to monitor for resistance development and resistance patterns in children failing second-line ART over 168 weeks
Status: Ongoing. Closed to recruitment. Patients are followed and monitored
Target/Enrolled: 300/299 (HIV-NAT=45)

The latent HIV Reservoir in Early treated Thai children

Study ID: HIV-NAT209
This is a prospective observational study that will characterize the HIV reservoir size and replication, and the HIV-specific immunity in HIV-infected young children who initiate antiretroviral therapy (ART) within the first 6 months of life and have sustained plasma virologic suppression
Status: Ongoing
Target/Enrolled: 225/54 (HIV-NAT=28)
Collaborator: Srinagarind Hospital, Faculty of Medicine Khon Kaen University; Nakornping Hospital, Chiang Mai; Chiangrai Prachanukroh Hospital; Hat Yai Hospital, Songkhla; Phrachomklao Hospital, Petchaburi; Siriraj Hospital, Mahidol University, Faculty of Medicine, Bangkok; Queen Sirikit National Institute of Child Health, Bangkok; VCI Chulalongkorn University; The University of Montreal, Montreal, Canada; The National Institutes of Health (NIH), Bethesda, Maryland;; The US Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR), MD, USA; Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok, Thailand; The National Institutes of Health, MD, USA

The PEARL study

Study ID: HIV-NAT152
Pediatric study for Appropriate dose of Ritonavir boosted Lopinavir in Thai HIV-infected children
Status: Closed April 2013
Target/Enrolled: 31/31
Site: total 11 sites (HIV-NAT, Thai Red Cross AIDS Research Center, Bamrasnaradura Infectious Disease Institute, Khon Kaen University, Nakornping Hospital, Prapokklao Hospital, Queen Sirikit National Institute of Child Health, Surin Hospital, Sappasitthiprasong Hospital, Udonthani Hospital, Buddhachinaraj Hospital, Phrachomklao Hospital

The pilot intervention of perinatally HIV infected children and their caregivers for the adaptation of the collaborative HIV prevention and adolescent mental health program (CHAMP+) in Thailand

Study ID: HIV-NAT224
This study is conducted in 2 phases. The first phase is the pilot phase which assessed the intervention’s feasibility. The second phase examined the impact of Champ + intervention on perinatally infected youth and their caregivers, make any necessary modifications to the intervention to assure it is culturally and contextually relevant. Additional information can be obtained from section entitled, “Summary report of the activities for HIV-infected children and parents at the Thai Red Cross AIDS Research Centre”.
Status: Closed April 2014
Target/Enrolled: 100/88 children from 4 sites
Collaborator: Phetburi Hospital, Khon Kaen Hospital, and Khon Kaen University

Third line HAART in HIV-infected children

Study ID: HIV-NAT113
This study will assess efficacy and safety of third line regimen in 150 Thai children.
Status: Closed July 2013
Target/Enrolled: 55/55
Collaborator: Chulalongkorn Hospital, Siriraj Hospital, Bamrasnaradura Infectious Disease Institute, Chiang Rai Regional Hospital, Srinagarind Hospital Khon Kean University, Nakornping Hospital, Prapokklao Hospital and Surin Hospital
Site Pls: Kulkanya Chokephaibulkit, Jurai Wongsawat, Rawiwan Hansudewechakul, Pope Kosalaraksa, Suparat Kanjanavanit, Chaiwat Ngampiyakul, Pakarat Sangkla
Site: Chulalongkorn Hospital, Siriraj Hospital, Bamrasnaradura Infectious Disease Institute, Chiang Rai Regional Hospital, Srinagarind Hospital Khon Kean University, Nakornping Hospital, Prapokklao Hospital and Surin Hospital
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