Abstract

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

  Funding Agency

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

  Institution

Name
HIV-Nat, the Thai Red Cross AIDS Rch Center
Department
Type
DUNS #
671556129
City
Bangkok
State
Country
Thailand
Zip Code
10330

  Publications

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
Bunupuradah, Torsak; Hansudewechakul, Rawiwan; Kosalaraksa, Pope et al. (2015) HLA-DRB1454 and predictors of new-onset asthma in HIV-infected Thai children. Clin Immunol 157:26-9
Ananworanich, Jintanat; Kerr, Stephen J; Jaimulwong, Tanyathip et al. (2015) Soluble CD163 and monocyte populations in response to antiretroviral therapy and in relationship with neuropsychological testing among HIV-infected children. J Virus Erad 1:196-202
Kerr, Stephen J; Puthanakit, Thanyawee; Vibol, Ung et al. (2014) Neurodevelopmental outcomes in HIV-exposed-uninfected children versus those not exposed to HIV. AIDS Care 26:1327-35
Intasan, Jintana; Bunupuradah, Torsak; Vonthanak, Saphonn et al. (2014) Comparison of adherence monitoring tools and correlation to virologic failure in a pediatric HIV clinical trial. AIDS Patient Care STDS 28:296-302
Puthanakit, Thanyawee; Ananworanich, Jintanat; Vonthanak, Saphonn et al. (2013) Cognitive function and neurodevelopmental outcomes in HIV-infected Children older than 1 year of age randomized to early versus deferred antiretroviral therapy: the PREDICT neurodevelopmental study. Pediatr Infect Dis J 32:501-8
Bunupuradah, Torsak; Kosalaraksa, Pope; Vibol, Ung et al. (2013) Impact of antiretroviral therapy on quality of life in HIV-infected Southeast Asian children in the PREDICT study. AIDS Patient Care STDS 27:596-603
Puthanakit, Thanyawee; Saphonn, Vonthanak; Ananworanich, Jintanat et al. (2012) Early versus deferred antiretroviral therapy for children older than 1 year infected with HIV (PREDICT): a multicentre, randomised, open-label trial. Lancet Infect Dis 12:933-41
Haas, David W; Mootsikapun, Piroon; Ruxrungtham, Kiat et al. (2012) Clinical perspectives on human genetic screening to prevent nevirapine toxicity. Per Med 9:773-782

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