Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433030
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2007-02-08
Brief Title:
Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand
Sponsor:
Institut de Recherche pour le Developpement
Organization:
Institut de Recherche pour le Developpement
Study Overview
Official Title:
Observational Cohort of HIV Infected Adults and Children in the PHPT Network Hospitals in Thailand
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Since 2004 the Thai Ministry of Public Health has massively scaled up antiretroviral treatment programs to provide therapy to more than 80000 patients with partial support of the Global Fund to fight AIDS Tuberculosis and Malaria GFATM
As access to HIV care continues to expand under the universal health coverage system it is important to document and analyze the efficacy tolerance toxicity and acceptability of antiretroviral therapy within pilot treatment programs to provide evidence based feedback and recommendations to the national program and policy makers
As access to HIV care continues to expand under the universal health coverage system it is important to document and analyze the efficacy tolerance toxicity and acceptability of antiretroviral therapy within pilot treatment programs to provide evidence based feedback and recommendations to the national program and policy makers
Detailed Description:
As Thailand is rapidly expanding access to antiretroviral treatments under the universal health coverage system it is crucial to document and learn from pilot antiretroviral treatment programs in particular the medical outcomes and logistical and organizational issues faced by hospital teams and patients in order to adapt the ARV delivery and monitoring system to various local settings
Specific objectives
1 Analyze data collected in patients participating in the PHPT antiretroviral treatment program in accordance to national and international guidelines with no experimental interventions
2 To determine factors associated with treatment outcome including immune status virologic factors and antiretroviral drugs levels
3 To study the operational aspects of integrating comprehensive HIV care into the existing care system with regards to new activities generated at the hospital level counseling referral systems biological monitoring the impact on other health activities mobilization of human and financial resources affordability and sustainability
The population of the study consists of approximately 2000 consenting HIV-infected patients including one-third of children receiving HIV care as part of the GF-ATM or OXFAM Access to Antiretroviral programs presenting at any of the PHPT network hospitals
Specific objectives
1 Analyze data collected in patients participating in the PHPT antiretroviral treatment program in accordance to national and international guidelines with no experimental interventions
2 To determine factors associated with treatment outcome including immune status virologic factors and antiretroviral drugs levels
3 To study the operational aspects of integrating comprehensive HIV care into the existing care system with regards to new activities generated at the hospital level counseling referral systems biological monitoring the impact on other health activities mobilization of human and financial resources affordability and sustainability
The population of the study consists of approximately 2000 consenting HIV-infected patients including one-third of children receiving HIV care as part of the GF-ATM or OXFAM Access to Antiretroviral programs presenting at any of the PHPT network hospitals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None