TApHOD
Study title
The Treat Asia Paediatric HIV Observational Database
Study Code
TApHOD
Network
TREAT Asia
Study PI
Prof. Virat Sirisanthana, M.D.
Study Co PI
Linda Aurpibul, M.D.
Study sites
18 sites in 7 countries, Thailand Cambodia Malaysia Indonesia India and Vietnam
Funding agency
- amfAR, The Foundation for AIDS Research
- AIDS Life Association
- U.S. National Institutes of Health (NIH)
- The Kirby Institute, UNSW Australia
Study design
The protocol design is an open observational cohort of HIV-infected children and adolescents.
Study objective
- Examine HIV natural history, including relationships between access to ART and disease progression in pediatrics
- Develop capacity for systematic and standardized pediatric HIV clinical data collection in countries of the Asia-Pacific region
- Monitor pediatric ARV and prophylactic treatment as related to demographics and markers of HIV disease stage and progression
- Monitor toxicity to ART in children and adolescents
- Assist in evaluation of new pediatric HIV treatments in the Asia-Pacific region.
Number of enrolled participants (overall/at RIHES)
Participating clinical centers will enroll and follow all eligible patients receiving HIV care. There is no maximum sample size for each site. However, it is expected that clinical centers will enroll and continuously follow a minimum of 50 participants for TApHOD, unless otherwise approved by TREAT Asia.
For Faculty of Medicine and Research Institutes for Health Sciences (RIHES), Chiang Mai University enrolled 303 perinatally HIV-infected children and adolescents to the study.
Year: started
Aril 2007
Year: expected to finish
NA
Significance
In 2006, UNAIDS estimated that, worldwide, 2.3 million children under the age of 15 years were living with HIV and 380 000 children died from AIDS.
Epidemiological research has shown that there are critical differences in disease progression between children and adults. Largely due to the lower efficiency of a child’s immature (but developing) immune system, children experience a much more rapid disease progression and a much shorter duration of each stage of HIV disease. In the absence of any intervention, the majority of perinatally HIV-infected children develop HIV-related symptoms by six months of age.
The natural course of HIV disease in the absence of treatment is often short and progresses more rapidly in a majority of children, with very few long-term survivors. Studies in resource-constrained countries indicate that the risk of death in untreated HIV-infected infants is 45% at two years and 62% at five years. Delayed diagnosis of HIV infection, poor nutrition, and high levels of severe bacterial, respiratory and gastrointestinal tract infections are likely reasons for the higher early mortality.
In children, drug metabolism varies with age and maturation leading to differences in the drug distribution and clearance. The pharmacokinetic (PK) data are not consistently available in young children and variations in PK (between and within individuals) are frequently greater in children than in adults. New children formulations are needed to treat infants and very young children. Further research is a necessary step to reach scaling-up of paediatric ART in resource-poor settings.
The use of combination antiretroviral therapy (ART) has led to reduced morbidity and mortality caused by HIV infection. In every setting where ART has been used, death rates have dropped, as well as the incidence of hospitalizations and incidence of opportunistic infections even in children.
A broad range of resources for HIV/AIDS management exists in countries of the Asia-Pacific region; there is widespread access to antiretroviral therapy in some countries, however, in others access is extremely limited. For example, in Australia around 60% of people diagnosed with HIV are estimated to be receiving antiretroviral therapy, with over 80% of these people receiving three or more drugs (AHOD, 2000). In contrast, in many developing countries of the region the proportion of people with HIV who have received antiretroviral therapy is less than 1% (Dore & Cooper, 2001).
However, access to antiretroviral therapy has improved in some countries in recent years and should continue to improve. Price reductions for most antiretroviral therapy agents have been considerable, generic products are increasingly employed, and a global fund has recently been established to provide funds for access to treatments for HIV, tuberculosis and malaria.
The impact of more widespread introduction of antiretroviral therapy for children in the Asia-Pacific region will depend on several factors. First, health care worker education in delivery and monitoring of antiretroviral therapy is required. Second, laboratory capacity needs to be developed for HIV diagnosis, staging and therapeutic monitoring. Third, evaluation of various therapeutic regimens will be required to assess safety and efficacy in different settings. Fourth, programmatic research will be crucial to the overall evaluation of the impact of antiretroviral therapy. The latter incorporates collection of clinical data on children receiving care for HIV/AIDS including markers of HIV disease progression and therapeutic uptake.
Currently, there is limited information relating demographic factors, markers of HIV disease stage and antiretroviral treatment choices in paediatric clinic sites in most countries of the Asia-Pacific region. Such data are important to inform the cycle of quality assurance required for continuing improvement of paediatric HIV medical care. There is also wide variation in the extent of systematic clinical data collection between countries and within countries among clinic sites. Several individual clinic sites in countries of the Asia-Pacific region are setting up computerised patient management systems which will collect clinical data including antiretroviral treatments during routine medical care of people with HIV. Other sites will require resources to establish similar mechanisms of clinical data collection.
To address similar questions in adults in the Asia-Pacific region, the TREAT Asia Network developed and implemented in 2003. TAHOD is a prospective multi-centre, observational study of patients with HIV that aims to assess the natural history of HIV disease in treated and untreated patients. TAHOD is currently comprised of 17 clinical sites in 13 countries and has enrolled over 3,000 patients, most of whom are receiving antiretroviral therapy.
TAHOD, and the similar Australian HIV Observational Database (AHOD) have shown collection and collation of a limited number of core data variables from different clinical sites is a feasible method for creating a useful HIV database
A similar project, the TREAT Asia Paediatrics HIV Observational Database (TApHOD) is designed to collect and collate clinical paediatric data from countries of the Asia-Pacific region.
Study website (if any)
http://www.amfar.org/around-the-world/treat-asia/publications/treat-asia-report/
