Pediatric Clinical Research in Asia

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Pediatric Clinical Research in Asia

• The TREAT Asia Pediatric Network
• July 2008

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Developing an Asian Regional Network

• History
• Characterization of the network
• Observational database
• Future directions

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History

• September 2005 18 clinical programs in 7 Asian
  countries invited to establish a regional
  pediatric research network
• February 2006 working group identified research
  priorities
• November 2006 TREAT Asia Pediatric Network
  launched
• Cambodia, China, India, Indonesia, Laos,
  Malaysia, Thailand, Vietnam
• Funding through Austrian AIDS Life Association
  (AALA), amfAR

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Characterization of the Network

• On-line site survey, preliminary results
• 17 of 20 sites, 79 questions
• Facility
• Public/government facilities 16 (94)
• University-affiliated and hospital-based 7 (41)
• Clinic visits in the previous month 117 (4-611)
• ART
• Year began providing ART 2001 (1994-2006)
• Number of children on ART 166 (17-656)
• Participation in other clinical trials or
  research 9 (53)

results are as total N () or median (range)
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Characterization of the Network

• PMTCT
• Exclusive formula-feeding recommended 15 (88)
• Free formula provided 14 (82)
• Lab
• Access all of the time, when needed, to
• CD4 15 (88)
• DNA PCR 13 (77)
• RNA VL 13 (77)
• Genotype 8 (47)

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TREAT Asia Pediatric HIV Observational Database
(TApHOD)

• First project
• Program support through TREAT Asia/amfAR
• Data management and analysis through NCHECR
• Funding through AALA, NICHD, NIH OAR, NIAID,
  amfAR
• March 2007 protocol version 1
• August 2007 completion of Access database

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TApHOD

• Data collection
• Submitted twice a year to NCHECR
• March-April 2008 first data transfer
• 9 sites in India, Malaysia, and Thailand
• 1400 patients
• Retrospective data included from 8 sites (1991 ?
  present)
• September 2008 second data transfer
• 3 additional sites in Cambodia, Indonesia,
  Malaysia
• 2300 patients

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Leadership and Collaboration

• Data owned by individual sites, managed by a
  steering committee
• Concept sheet and authorship protocols
• 3 approved, 1 under review
• Cohort profile
• Site survey
• Mortality
• Opportunistic infections
• Contact
• Monthly conference calls
• Annual network meeting
• Annual workshop (planned)

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Challenges

• Regulatory
• US OHRP FWA and registered IRB
• Local authorities
• Data management
• Access training

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Current Research ? Future Directions

• Treatment initiation
• PREDICT immediate or deferred treatment for
  children with moderate immune suppression
• Disclosure and adherence
• Treatment failure and second-line options
• Genotype-driven salvage
• Lower dose LPV/r 70 of WHO-recommended dose
• Double PI toxicity, efficacy, maintenance with
  monotherapy after VL suppression

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TApHOD Principle Investigators

• A Bowen, Sydney Children's Hospital, NSW, Sydney
  Australia
• A Sohn, UCSF-Vietnam, Ho Chi Minh City, Vietnam
• BV Huy and NV Lam, National Hospital of
  Pediatrics, Hanoi, Vietnam
• DA Cooper, MG Law, J Amin and A Kariminia ,
  National Centre in HIV Epidemiology and Clinical
  Research, The University of New South Wales,
  Sydney, Australia
• FJ Zhang and N Han, Beijing Ditan Hospital,
  Beijing, China
• FS Moy and M Thien, Hospital Likas, Kota
  Kinabalu, Malaysia
• G Jourdain, PHPT, Chiangmai, Chiang Mai,
  Thailand
• J Tucker, New Hope for Cambodian Children, Phnom
  Penh, Cambodia
• K Chokephaibulkit and N Seetapun, Siriraj
  Hospital, Mahidol University, Bangkok, Thailand
• K Frost, J Smith and J Pang, The Foundation for
  AIDS Research, New York, USA
• K Razali and NF Abdul Rahman, Pediatric
  Institute, Hospital Kuala Lumpur, Kuala Lumpur,
  Malaysia
• LK Do and LN Oanh, Worldwide Orphans Foundation
  (WWO), Ho Chi Minh City, Vietnam
• N Kumarasamy and S Saghayam, YRG Centre for AIDS
  Research and Education, Chennai, India
• N Kurniati and H I Satari, Cipto Mangunkusumo
  General Hospital, Jakarta, Indonesia
• NK Nik Yusoff and L C Hai, Hospital Raja
  Perempuan Zainab II, Kelantan, Malaysia
• P Lumbiganon and P Tharnprisan, Khon Kaen
  University, KhonKaen, Thailand
• R Hansudewechakul and S Watanaporn, Chiang Rai
  Regional Hospital, Chiang Rai, Thailand
• R Nallusamy and K C Chan, Penang Hospital,
  Penang, Malaysia
• S Seitaboth and K Nearyroth, Angkor Hospital for
  Children, Siem Reap Cambodia

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Program Support
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Final TApHOD Variable List

• Demographics 21 variables
• Diagnostic testing 15 variables
• Family status 14 variables
• Serology, other 19 variables
• Opportunistic infection 7 variables
• CD4 and HIV tests 8 variables
• Other lab and physical examination 26 variables
• Antiretroviral therapy 10 variables
• Prophylaxis 5 variables
• Adverse events 9 variables