TREAT Asia Sites Pioneer Regional HIV Observational Database

June 2003—In an important first for multi-country collaboration on HIV research, clinical sites in China, Hong Kong, India, Japan, Malaysia, the Philippines, Singapore, Taiwan, and Thailand have signed on to participate in a coordinated HIV/AIDS observational database program that has been launched under the auspices of TREAT Asia.

In most countries in Asia and the Pacific, critical data on HIV/AIDS is limited or simply doesn’t exist. Information such as demographic statistics and data on access to treatment and care are crucial to creating strategic responses to HIV/AIDS in the region. In a pioneering effort to collect this essential data, TREAT Asia has launched the first ever HIV Observational Database covering Asia and the Pacific. With 11 sites signed on initially, the program will expand to others in the region. Sites in Vietnam, Cambodia and Indonesia have already expressed interest in joining this groundbreaking project.

Participating sites will use standardized methods to collect anonymous patient data that will then be transferred electronically to the University of New South Wales National Centre in HIV Epidemiology and Clinical Research (UNSW NCHECR), where it will be collated and processed. The university’s Human Research Ethics Committee has approved TAHOD and amfAR’s Board of Directors has granted funding for the initiative.

A pilot data transfer is scheduled to take place in late June, and the first full transfer is planned for September. Subsequent data transfers will occur twice annually, in March and September. Initial analyses from the database could be ready for presentation as early as mid-2004 in time for the International Conference on AIDS in Bangkok, Thailand.

The information gathered through the observational database will inform the development of more effective research and treatment programs, and ultimately help to define treatment standards for Asia and the Pacific—standards that may differ from those in Europe and the United States. It is hoped that TAHOD’s cost-effective, innovative methodology will serve as a model for monitoring HIV/AIDS in other regions of the world.

The observational database has several long-term goals. It seeks to improve HIV clinical data collection throughout the Asia-Pacific region; assist in evaluating new HIV treatments; monitor antiretroviral and prophylactic treatment as it relates to demographics and markers of HIV disease stage; monitor toxicity related to antiretroviral therapy; and examine HIV’s natural history, including the relationship between access to antiretroviral therapy and disease progression.

Each participating site is recruiting a minimum of 200 subjects and will record variables such as sex, age, ethnicity, HIV-exposure category, HIV subtype, AIDS-defining illnesses, immunology and virology, antiretroviral and prophylactic treatment, and reasons for treatment changes. All sites are required to obtain approval from their respective ethics committees.

TAHOD’s principal investigator, Dr. Matthew Law, heads the Biostatistics & Databases Program and is a senior lecturer at UNSW. Dr. David Cooper, director of UNSW NCHECR, has been instrumental in the development of the observational database and will serve as its co-principal investigator.

With their successful implementation of the Australian HIV Observational Database (AHOD) in 1999, the team at the University of New South Wales National Centre in HIV Epidemiology and Clinical Research has demonstrated the effectiveness of electronic transfer and combination of core variables from computerized systems at different clinical sites.

“We have a great deal of experience in this area, and over the years we’ve been able to refine our methodology,” said Dr. Law. “We know from our experience that TAHOD will generate invaluable data to help shape comprehensive, strategic approaches to HIV/AIDS research and treatment in the region.”