Objectives To conduct a randomised, open label study to test whether a strategy of initiation of antiretroviral therapy shortly after commencing tuberculosis chemotherapy (2 weeks) achieves a significantly improved outcome when compared to a strategy in which antiretroviral therapy is deferred until the induction phase is complete (2 months) Specific aims ? To evaluate the efficacy, safety and tolerability of two strategies for the management of HIV related TB disease ? To improve the clinical management of patients with HIV/TB co-disease ? To establish a system of direct observation of therapy for HIV related TB Methods ? The study will be conducted in both inpatient and outpatient settings in Thailand and Cambodia. ? All patients newly diagnosed with first episode tuberculosis and co-infected with HIV will receive standardised TB short-course chemotherapy. ? Patients will be randomised to receive antiretroviral therapy to commence either early in the course of tuberculosis treatment (at two weeks) or deferred until TB therapy has been completed (at two months). ? Patients in both arms will receive the same combination of antiretroviral drugs

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
4U19AI053741-06
Application #
7900782
Study Section
Special Emphasis Panel (ZAI1-EC-A (S4))
Project Start
2009-06-01
Project End
2011-05-31
Budget Start
2009-06-01
Budget End
2010-05-31
Support Year
6
Fiscal Year
2009
Total Cost
$58,828
Indirect Cost
Name
HIV-Nat, the Thai Red Cross AIDS Rch Center
Department
Type
DUNS #
671556129
City
Bangkok
State
Country
Thailand
Zip Code
10330
Paul, Robert; Apornpong, Tanakorn; Prasitsuebsai, Wasana et al. (2018) Cognition, Emotional Health, and Immunological Markers in Children With Long-Term Nonprogressive HIV. J Acquir Immune Defic Syndr 77:417-426
Paul, Robert; Prasitsuebsai, Wasana; Jahanshad, Neda et al. (2018) Structural Neuroimaging and Neuropsychologic Signatures in Children With Vertically Acquired HIV. Pediatr Infect Dis J 37:662-668
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Bunupuradah, Torsak; Puthanakit, Thanyawee; Kosalaraksa, Pope et al. (2012) Poor quality of life among untreated Thai and Cambodian children without severe HIV symptoms. AIDS Care 24:30-8
Kosalaraksa, Pope; Bunupuradah, Torsak; Vonthanak, Saphonn et al. (2012) Prevalence of anemia and underlying iron status in naive antiretroviral therapy HIV-infected children with moderate immune suppression. AIDS Res Hum Retroviruses 28:1679-86

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