Coming Soon     BAGNKOK SYMPOSIUM 2002 on HIV MEDICINE     January 16-18, 2002      World Class Experts and Speakers     The Best Updating for HIV/AIDS Treatment and Care    BANGKOK SYMPOSIUM 2002   

 

 

  The HIV Netherlands Australia Thailand Research Collaboration
   Thai Red Cross AIDS Research Centre

  HIV-NAT
Starting Year: 1996 
Main Topic Area: Antiretroviral therapy and HIV care
Other Topic Areas: Access to drugs, Virology, immunology, and laboratory practices 
  Implementers
The project was implemented by the AIDS Research Centre of the Thai Red Cross Society (TRCARC); the Netherlands National AIDS Therapy Evaluation Centre (NATEC): Australian National Centre in HIV Epidemiology and Clinical Research (NCHECR).
   Funding

Starting expenses, core infrastructure (office and laboratory), and salaries of some research staff members were funded by TRCS, NATEC, and NCHECR. Expenses for the studies performed (including the majority of research staff salaries, research drugs, and laboratory assays) and presentation of the results at meeting were funded by the sponsors of the studies, ranging from pharmaceutical companies to the AIDS Division of the Thai Ministry of Public Health (MOPH) and the US National Institutes of Health (NIH). Additional training of Netherlands-Australia-Thailand HIV Research Collaboration (HIV-NAT) staff was funded by NCHECR, NATEC, and sponsors of the studies. Funding for training of others by HIV-NAT staff was provided by HIV-NAT, the party requesting the training, and/or a sponsor (e.g., the World Health Organization, Thai MOPH, or a pharmaceutical company)

  Objectives

  Primary objectives

  1. To establish a multi-centre HIV clinical research organization in Thailand that functions according to internationally accepted Good Clinical and Laboratory guidelines 

  2. To conduct clinical intervention studies (and potentially vaccine studies) that will yield answers to locally and regionally relevant research questions 

  3. To convince international pharmaceutical companies and other potential sponsors that scientifically and ethically sound HIV clinical studies can be conducted in Thailand, and that they should invest in such research in Thailand 

  4. To make drugs available to study participants 

  5. To strengthen the HIV research infrastructure and regular HIV care infrastructure

  6. To provide health care workers with valuable experience with newly available treatments. 

 

   The secondary objectives

To serve as a training centre in the practical, ethical, and scientific aspects of HIV care, and in particular of HIV clinical trials, for staff from government and university hospitals and other related organizations in Thailand and the region. 
   Main Activities

At least six clinical studies have been successfully completed and another five are currently ongoing at three sites in Bangkok, providing up to 1000 HIV-positive individuals with effective treatment. Validated quality-of-life research has been an integrated part of one protocol and will be expanded in future studies. 

Results of studies are shared with local HIV-treating physicians and Thai policy-makers and are presented at international meetings. 

HIV-NAT staff have taught at least 6 courses concerning the conduct of HIV clinical research and principles of Good Clinical and Laboratory Practice, twice at the invitation of the AIDS Division of the MOPH. 

HIV-NAT has organized two national and two regional meetings for health care workers who have limited access to international journals, information technology, and international meetings. Sponsorship was found, enabling these health care workers to travel to the meetings, which had well-known international speakers in the field of HIV care and research. 

Ongoing and planned studies and the quality of the research are reviewed yearly by an International Advisory Board with 10 expert members. Interim analysis safety and efficacy results of studies are reviewed by an Independent Data and Safety Monitoring Board of three members. All HIV-NAT staff take part in educational activities, often supported by speakers from NATEC or NCHECR with a particular skill. 
   Outcomes/outputs

Few objective measures are available yet. However, since the first completed study (and the positive feedback received from the United States auditors sent by the sponsor of that study), starting new studies and finding sponsors for proposed studies has been easier; HIV-NAT is now actually actively pursued by potential sponsors as a clinical trial site. Study-related income enabled HIV-NAT to provide the involved laboratories with some needed infrastructure. Visits from NATEC and NCHECR staff and sponsor audit teams have improved study and laboratory conduct, which have benefited HIV-NAT's educational activities. As well, study results and advice from the International Advisory Board are heard and taken seriously by local policy-makers. 

Informal evaluation forms, completed by participants attending the educational meetings, clearly indicate that the educational activities meet an important need felt by health care workers in the country and region. Financially, the organization is nearly self-supporting through its study-generated income, and it needs to rely less and less on overseas skills and intellectual support. 

For the first three protocols, HIV-NAT was unable to guarantee follow-up medication to participants upon initiation of the study. However, it was able to enrol all interested participants in follow-up protocols after the sponsors' confidence grew and enthusiasm for the activities increased. For the most recent study, it was able to obtain long-term drug-availability guarantees, either directly from the sponsor or through a reduced pricing scheme
  Lessons Learnedd

The major lesson learned from the experience of this project is that, properly planned and executed, such international cooperation on HIV/AIDS clinical practices can have valuable benefits for local populations and medical service providers. Among the specific lessons learned: 

Clinical trials can be conducted in Thailand according to Good Clinical and Laboratory Practice (GCLP) guidelines and should be feasible in other settings outside the Western world. However, not all parties involved in clinical research outside the Western world may work according to these standards. The majority of potential sponsor will demand that this standard be implemented. Therefore non-Western research organizations must have the resources (especially time) and the willingness to support and facilitate close collaboration with local institutional ethical committees, hospital laboratories, and local pharmaceutical companies in pursuing GCLP. 

A clinical trial is labour-intensive: adequate personnel, willing to learn new skills, have to be available at a site if a trial is to succeed. It was learned that without dedicated staff and a responsible coordinator at every individual research site, success is impossible. Setting up a single site and expanding the research activities to three sites in the course of two years has been successful. "Long-distance expansion" based on theoretical knowledge, without an initial physical presence by the HIV-NAT team, seemed not to work, given the multidisciplinary nature of clinical trials and the fact that for most staff the trial is only one of many duties. 

Clinical trials do create access to drugs, but only for a limited number of people. Drug access may therefore not be an appropriate primary goal for becoming involved in research. 

Although economic difficulties are the main reason, limited access to anti-HIV drugs in Thailand is also due to a relatively slow registration process of newly available anti-HIV agents and a rather passive attitude on the part of some local pharmaceutical representatives. HIV-NAT's experiences is that if clinical studies are initiated in collaboration with the companies' headquarters, the local subsidiaries are forced into a pro-active import approach. As well, valuable local experience is gained and local data are generated that help the pharmaceutical companies facilitate the registration of the agents. 

Simply establishing a programme, doing the studies, and generating useful data seem to exert pressure on government agencies, local pharmaceutical company representatives, and ethical committees to re-evaluate their tasks and performance in the areas of HIV care, clinical research, and importation and provision of drugs. 
 
 
 

Organization Structure 
and staffs

 Directors

Prof. Praphan Phanuphak, MD, Ph. D., TRC-ARC and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

Prof. David Cooper, MD, Ph. D., NCHECR, Sydney, Australia

Prof. Joep Lange, MD, Ph.D., IATEC, Amsterdam, Netherlands

 Deputy Director

A. Prof. Kiat Ruxrungtham, MD, MSc. Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

 HIV-NAT Staffs : Full time Employed by HIV-NAT, NATEC or NCHECR

Dr Chris Duncombe (Australia) Senior Trial Physician/Clinical Trials Co-ordinator

Dr Chaiwat Ungsedhaphand (Thailand) Physician/Clinical Trials Co-ordinator 

Dr Peter Cardiello (USA), Physician/Clinical Trials Co-ordinator 

Dr Mark Boyd (Australia) Physician/Clinical Trials Co-ordinator 

Dr. Jintanat Ananworanich (Thailand), Physician/Clinical Trials Co-ordinator 

Ms Techinee Chuenyam Manager and Co-ordinating Clinical Trials Nurse

Ms. Metta Tongtalung Clinical Trials Nurse

Ms. Suchada Manotaya Clinical Trials Nurse

Ms. Tarika Monhaphol Clinical Trials Nurse

Mr Chowalit Phadungphon Data Manager

Ms Jeerakan Janhom Secretary 

Ms Gunyanee Sattong Assistant Nurse

Ms Sasiwimol Ubolyam Laboratory Mananger

Mr Apicha Mahanotharit Medical Technologist

Mr Theeradej Boonmangum Laboratory Technician

 Part-time HIV-NAT staffs: Employed by the Thai Red Cross Society and/or the Faculty of Medicine, Chulalongkorn University and/or HIV-NAT

Dr Mana Khongphattanayothin Data Analyst/Statistician HIV-NAT Staff 


John Liddy
, Research Associate

Sunee Sirivichayakul Medical Technologist 

Somboon Nookhai Medical Technologist 

Supranee Buranapraditkul Medical Technologist 

Somsong Teeratakulpisarn Clinical Trials Nurse 

Dr Jettanong Klawsongkram Clinical Trials Physician 

 Contact Information

HIV-NAT, Thai Red Cross AIDS Research Centre
Tel:   66-2-256-4638 
FAX: 66-2-2547574

Postal address
104 Rajdrumri Rd., Bangkok 10330 THAILAND

Electronic mail

General Information: chris.d@chula.ac.th
Webmaster:
rkiat@yahoo.com

 

 


Coming Soon     BAGNKOK SYMPOSIUM 2002 on HIV MEDICINE     January 16-18, 2002      World Class Experts and Speakers     The Best Updating for HIV/AIDS Treatment and Care    BANGKOK SYMPOSIUM 2002   

 
2001 HIV-NAT. All rights reserved
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