Studies
Clinical Research Programs in Co-tuberculosis Infections

IeDEA TB genomics

Study ID: HIV-NAT188
Impact of HIV infection on the population genomics of drug-resistant Mycobacterium tuberculosis: insights from macro-evolutionary analyses. This study will investigate the macroevolution of drug-resistant M. tuberculosis.
Status: Ongoing

LPV RMP

Study ID: HIV-NAT104
A pilot study of the pharmacokinetics and safety of lopinavir/ritonavir 400/100 mg bid versus lopinavir/ritonavir 600/150 mg bid combined with nucleoside analogue reverse transcriptase inhibitors in HIV/TB co-infected patients receiving rifampicin containing anti-tuberculosis therapy. This is a pilot study of the pharmacokinetics and safety of lopinavir/ritonavir 400/100mg bid versus lopinavir/ritonavir 600/150 mg BID combined with nucleoside analogue reverse transcriptase inhibitors in HIV/TB co-infected patients receiving rifampicin containing anti-tuberculosis therapy.
Status: Closed Aug 2015
Target/Enrolled: 40/23
Collaborator: David Burger (Radboud University Medical Center, The Netherlands), Kamol Kawkitinarong and Gompol Suwanpimolkul (Infectious Disease, Chulalongkorn University) and Supannee Jirajariyavet (Infectious Disease, Taksin Hospital)
Site: TRC-ARC and Chulalongkorn Hospital

Optimize TB Treatment outcome in Tertiary Care Hospitals

Study ID: TB NRU
This is a prospective cohort of patients suspected to have tuberculosis regardless of AFB, x-ray of the lungs and CT scan results.
Status: Closed Aug 2015
Collaborator: Disease Department Control (DDC), Thailand
Site Pls: Bamrasnaradura Infectious Disease Institute: Kamon Kawkitinarong; Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University: Opass Puthacharoen
Site: Bamrasnaradura Infectious Disease Institute, Rajvethi Hospital, Chulalongkorn University (Chest Unit, Internal Medicine Department, and Division of Infectious Diseases, Department of Medicine, Chulalongkorn University Hospital)

Regional TB Study

Study ID: HIV-NAT170
Socio-Economic Determinants of Tuberculosis (TB), Multidrug-resistant TB, and Immune Reconstitution Syndrome in HIV-TB Co-infected Patients in Asia. This is a case-control study that will assess the socio-economic risk factors for TB diagnosis.
Status: Closed Feb 2015
Target/Enrolled: 400/10; 50 at HIV-NAT, 200 for all sites in Thailand
Collaborator: Beijing Ditan Hospital, Beijing, China ; Queen Elizabeth Hospital, Hong Kong, China SAR ; Y.R. Gaitonde Centre for AIDS Research & Education, Chennai, India; Institute of Infectious Diseases, Pune, India; Sanglah Hospital, Udayana University, Denpasar, Indonesia; Cipto Mangunkusumo General Hospital, Jakarta Pusat, Indonesia; University of Malaya Medical Centre, Kuala Lumpur, Malaysia; Sungai Buloh Hospital, Sungai Buloh, Malaysia; Research Institute for Tropical Medicine, Muntinlupa City, Philippines; Tan Tock Seng Hospital, Singapore; Taipei Veterans General Hospital, Taipei, Taiwan; Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; National Hospital of Tropical Diseases, Hanoi, Vietnam; Bach Mai Hospital, Hanoi, Vietnam

Rifabutin with lopinavir/ritonavir

Study ID: HIV-NAT116
This is a pilot, randomized, open-label, 2-arm per group, parallel, phase II study that will describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg thrice weekly in combination with LPV/r 400/100 mg based cART in HIV/TB infected patients.
Status: Opened Oct 2015. Recruiting
Target/Enrolled: 40/27
Collaborator: Faculty of Medicine, Chulalongkorn University and Bamrasnadura Institute

Short Course Treatment of Latent TB

Study ID: A5279
Phase III Clinical Trial of Ultra-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals with Latent Tuberculosis Infection. This study will compare rifapentine plus isoniazid daily for 4 weeks to a standard regimen of isoniazid alone daily for 9 months for the prevention of tuberculosis (TB) in HIV-infected participants who do not show evidence of active TB.
Status: Open Nov 2014. Ongoing. Closed to recruitment.
Target/Enrolled: 3000 globally with 24 at HIV-NAT

TB Immunology

Sub-study of: Optimize TB Treatment outcome in Tertiary Care Hospitals
Investigation of specific immune response pattern in persons with active tuberculosis before and after receiving anti-tuberculosis therapy. This study will evaluate the performance of the CD25/CD134 co-expression assay in detecting the recall response to TB antigens in persons with active TB diagnosed by positive sputum sample by Xpert MTB/RIF assay. Investigate specific effector and specific regulatory response before and after TB treatment in participants with active TB, and compare TB specific effector and TB specific regulatory responses between cases of active and latent TB.
Status: Ongoing. Closed to recruitment. Data is being analyzed. Anticipate study will be completed by Jan 2017.
Target/Enrolled: 100/100

TB SMS

Study ID: HIV-NAT173
This study will assess the causes of discontinuity of TB treatment and strategies to improve the treatment outcomes of TB treatment adherence in University Hospital
Status: Recruiting, ongoing and providing treatment
Target/Enrolled: Total 1300 (1000 retrospective; 300 prospective)/1,059 total (129 for HIV-NAT site)
Collaborator: Faculty of Medicine, Chulalongkorn University
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