1 / 22

Pediatric HIV Clinical Pharmacology Program Development in Thailand

Pediatric HIV Clinical Pharmacology Program Development in Thailand. Tim R. Cressey Research Associate, Harvard School of Public Health, USA PHPT-IRD, Chiang Mai University, Thailand 4 th Annual Workshop on Global HIV Clinical Pharmacology Capacity Building and Implementation Research

sanaa
Download Presentation

Pediatric HIV Clinical Pharmacology Program Development in Thailand

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Pediatric HIV Clinical PharmacologyProgram Development in Thailand Tim R. Cressey Research Associate, Harvard School of Public Health, USA PHPT-IRD, Chiang Mai University, Thailand 4th Annual Workshop on Global HIV Clinical Pharmacology Capacity Building and Implementation Research July 1st, 2013 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention Kuala Lumpur, Malaysia

  2. Chiang Mai PHPT: a research group created in 1996 in Chiang Mai, the epicenter of the HIV epidemics in Thailand at that time Main objectives are to determine strategies for preventing mother to child transmission of HIV, and HIV/AIDS treatment and care that can be integrated in the existing health care system.

  3. Programs for HIV Prevention and Treatmentwww.phpt.org(previously Perinatal HIV Prevention Trials) A collaborative initiative including researchers from: • Ministry of Public Health, Chiang Mai and Mahidol Universities in Thailand • Harvard School of Public Health and School of Medicine, Boston, MA, USA • Institut de Recherche pour le Développement, Institut National d’EtudesDémographiques and INSERM; Lyon 2 & Paris 7 University, France • International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) • Pediatric European Network for the Treatment of AIDS (PENTA) • RIHES, HIV-NAT, CDC, Mahidol University, Chulalongkorn University in Thailand; • Harvard, Seattle, Tours, Paris, Lyon, Liverpool Universities

  4. Network of 50 Public hospitals PHPT Network More than 120 physicians, 250 nurses, counselors, laboratory technicians, pharmacists, in a network of hospitals Laboratory dedicated to HIV Research at Chiang Mai University

  5. PHPT-AMS Laboratory • Established in 2001 at the Faculty of Associated Medical Sciences, Chiang Mai University • HIV RNA Viral Load, HIV Genotyping, HIV DNA-PCR, Antiretroviral drug level measurement

  6. Particular research focus on the pharmacokinetics of antiretroviral drugs in pregnant women and children

  7. PHPT-AMS Pharmacology Laboratory • 2005: Secured first HPLC Machine (Agilent LC1100)

  8. ARV Assay Development • Many high performance liquid chromatography assays (HPLC) with UV detection for single and multiple ARV drugs are available • A few HPLC assays can over the majority of ARV drugs

  9. Laboratory Quality Assurance System Standard Operating Procedures (SOPs) [Work Instructions (WI):documents describing test procedures for ISO15189 Accreditation]

  10. Quality ControlSamples External Quality Control (EQC) Programs • External Quality Controls sample from Clinical Pharmacology Quality Assurance and Quality Control, USA (CPQA) will be performed twice yearly. • To monitor inter-day assay variability QC samples provided from ASQUALAB (France, http://www.asqualab.com/) are included in each run.

  11. Internal Monitoring of QC samples

  12. Laboratory Accreditation PHPT Laboratory was first accredited by the Thai Medical Technology Council in 2005

  13. PHPT Pharmacology Laboratory: 2008

  14. 2009 2011

  15. ISO 15189: Medical Laboratory Accreditation • ISO 15189:2012 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognizing the competence of medical laboratories. • PHPT laboratory was ISO15189 accredited by Bureau of Laboratory Quality Standards, Thai MoPH, in 2011

  16. Supporting PK Research Studies Nevirapine Efavirenz Lamivudine Lopinavir/r

  17. Therapeutic Drug Monitoring (TDM)(within the PHPT-GFATM program) Since 2005 Samples: 9,300 tests performed Reasons Drug toxicity PI dosing in Children Dual-Boosted PIs Non-ARV drug-drug interactions

  18. Staff Training at CPQA, Buffalo, USA • Assay Validation • Quality Control, Quality Assurance, Competency, Laboratory Self-Assessment • Quality Data Management • New Technologies: UPLC and Mass Spectrometry

  19. 2013 Agilent 6460 LC-MS-MS

  20. Future Technology Transfers • Establish capacity to measure intracellular antiretrovirals concentrations • Establish capacity to measure antiretrovirals on dried blood (or plasma) spots (DBS) or hair samples • Continue the development of Laboratory Quality Assurance System (GLP, IS017025)

  21. Acknowledgments Support • Ministry of Public Health, Thailand • Thailand International Development Cooperation Agency (TICA) • NICHD, NIAID, USA • Institut de Recherche pour le Développement (IRD), France • Global Fund to fight AIDS, Tuberculosis and Malaria (THA-102-G01-H-00) This satellite was sponsored by the UB-UZ AIDS International Training Research program funded by the Fogarty International Center.

  22. Thank You

More Related