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Niyada Kiatying-Angsulee, Ph.D . Chair, Social Pharmacy Research Unit,

Ethics in Clinical Trial for AIDS Vaccine and Antiretroviral Drugs: Patient Perspectives in Thailand. Niyada Kiatying-Angsulee, Ph.D . Chair, Social Pharmacy Research Unit, Chulalongkorn University Thailand Niphattra Haritavorn, MA. PhD student Macquarie University Australia

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Niyada Kiatying-Angsulee, Ph.D . Chair, Social Pharmacy Research Unit,

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  1. Ethics in Clinical Trial for AIDS Vaccine and Antiretroviral Drugs:Patient Perspectives in Thailand Niyada Kiatying-Angsulee, Ph.D. Chair, Social Pharmacy Research Unit, Chulalongkorn University Thailand Niphattra Haritavorn, MA. PhD student Macquarie University Australia March 21st, 2007 8th Asian Bioethics Conference Bangkok Thailand

  2. Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK2

  3. Outline • AIDS in Thailand and health care provision • Regulatory Path • ARV and AIDS Vaccine Trials • Ethical Debates • The Situation: Patient Perspectives • Recommendations Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK3

  4. HIV/AIDS in Thailand First report 1984 • Cumulative HIV infection 2005 = 1,092,327 • Adults age 15-49 with HIV/AIDS, 2005 = 560,000 • New HIV infections, 2005 = 18,172 • New AIDS cases, 2005 = 48,932 • Adult HIV prevalence (%), 2005= 1.4 • Women age 15-49 with HIV/AIDS, 2005= 220,000 • Children with HIV/AIDS, 2005= 16,000 • AIDS orphans (ages 0-17), 2005= nd • AIDS deaths, 2005= 21,000 • Prevalence HIV in IDU = 40-50% Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK4

  5. Healthcare structure and ARV service • Healthcare provision • 10+ University hospitals • 20+Special Hospitals (MoPH) • 19 Regional hospitals (MoPH) • 76 General hospitals (MoPH) • 1,000 Community hospitals (MoPH) • Private hospitals and clinics • 10+ Medical Schools • 13 Pharmacy schools Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK5

  6. Increasing trend of clinical trials relating to AIDS and intervention • Care • Treatment • ARV • OI • Micronutrients • Others • Prevention • Vaccine • Other means Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK6

  7. ARV and AIDS trials in Thailand • Who and What (MoPH, University, TRC, BMA) • HIV-NAT 50 trials ARVs and others > 1500 • PHPT 49 sites (ARVs and others • TUC/BMA (AIDSVAX, Tenofovir, ?) • US Army medical center HIV Vaccine 16,000 • Where • Central = Bangkok, Samutprakarn, etc • North = Chiang Mai, Chiang Rai, Pistanulok, Lampun, etc • East = Rayong, Chonburi, Chantaburi, etc • North-east = Mahasarakham, Nakornratchasima, Kon Kaen • South = Songkla Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK7

  8. HIV Vaccine trial • AIDSVAX of VaxGen (2,546 participants and reported fail in 2003) • Tenofovir in BKK (on going) • Prime-boosted HIV vaccines in Chonburi and Rayong, involves 16,000 healthy people (recruiting) Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK8

  9. A randomized trial comparing several antiretroviral combinations for the prevention of the selection of resistance mutations after intrapartum single dose nevirapine. PACTG 1032. Gemini in 2005 60 Multicentre A 48-week, randomized, open-label, 2-arm study to compare the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-na?ve HIV-1 infected patients (Gemini Study) Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK9

  10. HIV Vaccine and ARV clinical trial Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK10

  11. $$$ Researchers Thai Clinical Trial Bioethics Arena International Codes Sponsors National RB???, Law??? IRB Community??? Institutes Patients/participants Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK11

  12. International Bioethics CodesAutonomy, Beneficence, Non maleficence, Justice • The Nuremberg Code 1947 • The Declaration of Helsinki 1964, …, 2004 • The Belmont report 1979 • CIOMS 1983, 1993, 2002 • WHO GCP 1995 • ICH GCP 1996 • UNAIDS guideline HIV vaccine research 2000 • EU Directive 2001  effective 2004 Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK12

  13. Thai Regulatory Path Governing Biomedical Research • Draft Law on Research on Human 1983, 1993, 2007 still as draft • Medical Council Act B.E. 2526 (1983) – code of ethics (self regulation) • Medical Council Act B.E.2526 (1983) – code of conduct for research and study in human being (self regulation) • Thai Research Council Guideline 2002 • Declaration of Thai Patient’s Rights (endorsed by four professional councils and MoPH) • Criminal Law and Civil law Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK13

  14. Declaration of Thai Patient’s Rights • Rights to health service as in Thai Constitution BE 2540 • Rights tofull medical services regardless of their status, • Right to receive their complete current information for decision • Rights to receive urgent and immediate relief • Rights to know the name-surname and the specialty of the practitioner Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK14

  15. Declaration of Patient Rights • Right to request a second opinion • Right to confidentiality • Right to information to take part in research • Right to full information in medical record • Representative for child, disable people • The patient is entitled to demand complete current information regarding his role in the research and the risks involved, in order to make decision to participate in/or withdraw from the medical research being carried out by their healthcare provider Treatment or Research? Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK15

  16. HIV vaccine trial diagram Risk vs Benefit Placebo HIV- Placebo HIV+ HIV- HIV- Vaccine IDU HIV+ Vaccine Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK16

  17. BioethicsDebates for HIV VaccineAutonomy, Beneficence, Non maleficence, Justice • Placebo arm = Risk behaviour to get HIV+ • Participants (IDUs) being arrested and could not continue the trial with risk from HIV incarceration • Chapter 23: Testing Vaccine in Injecting Drug Users: VaxGen’s efficacy trial in Thailand • Providing care and maintaining follow up of incarcerated participants in Asia’s first phase III HIV vaccine trial Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK17

  18. ARV trial diagram Risk vs Benefit Placebo HIV+ no effect Placebo HIV+ effective HIV+ HIV+ no effect ARV HIV+effective ARV Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK18

  19. BioethicsDebatesfor ARVAutonomy, Beneficence, Non maleficence, Justice • ARV is essential • ARV life long drugs • ARV use punctual and continuous ARV • Rate of resistant • Trial in HIV + in vulnerable group (Stigma, discrimination) Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK19

  20. Ethical Consideration for ARV trials • IRB approval (bias, quality) Sensitive issues • Vulnerable group versus stigmatization and discrimination (IDUs, CSW, Pregnant) • Placebo or standard treatment • Recruitment process • Coerce to join, fear of deny treatment, inducement • Same place as narcotic treatment may cause drawback • Inform consent and information • Information (document or discussion) to participants during trial (quality and quantity) Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK20

  21. Ethical Consideration for ARV trials • How to handle for those who cannot enroll or fail the inclusion criteria or those who get HIV+ during trial • Adverse events • Information • Treatment of ADR • Health insurance to cover • Resistant (how to help participants? During and post trial) • Post trial procedure • Test VRL, CD4, • OI treatment • ARV provision (first line, second line, third line) • Benefit to the country(accessibility, availability, affordability) Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK21

  22. Participants’ experience • ‘I found one mentioned enrolled in 2 trials at the same time because they (researchers) could not find enough participant and they did not ask me anything’ • ‘[He] brought the drugs back from the centre but did not take them, except when he went for the meeting’ • ‘I hardly used [illicit] drug now but they asked me to join the trial since they could not find any IDU, and I need methadone’ • ‘They have to go from one trial to another for money and for ARV’ • ‘My concern is about information to patients’ Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK22

  23. Patients’ Perspective • [inducement] How they were convinced to join the trial, did they have choices? Why did they decide to join? • [information] Which information they received before and during the trials? Can participants tell the name of ARV of their trials? • [Autonomy, choices] How many trials they have involved, what were the names of ARV/vaccine • [Non-maleficence] What were adverse events they experienced? How did they cope with them? • [Beneficence] Did they receive ARV after the trial, how long? • Etc. Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK23

  24. The Proposal: Human Rights Approaches • Community Advisory Board and Third party investigation • Recruitment process (preparedness, enough information, voluntary, fear) • During trial • Medical insurance • System for reporting adverse event • Management of adverse event • Post-trial process • Outcome report back to community • Drug Fund the whole life • Health services after trials • Benefit back to the country • Accessibility of products (availability and affordability) • Knowledge, information Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK24

  25. Thank You ! Clinical Trial for AIDS Vaccine and ARV: Patient Perspectives in Thailand, March 21, 2007 8th ABC NK25

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