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Efficacy, Safety and Pharmacokinetics of DTG with RIF
Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Summary
The overall aim of the project is to evaluate optimal DTG dose for the combined treatment of TB and HIV infections with RIF based anti-TB therapy. This Stage II trial will determine precisely the PK parameters of DTG in combination with RIF regimen in Thai HIV/TB co-infected patients. After the optimal dose of DTG has been found, it will be further tested in a larger Stage III trial to assess its safety, tolerability and efficacy when used with RIF based regimen.
Official title: Efficacy, Safety and Pharmacokinetics of Dolutegravir 50 Mg Once Daily with Food Versus Dolutegravir 50 Mg Twice Daily in HIV/TB Co-infected Patients Receiving Rifampin-based Antituberculosis Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2019-06-25
Completion Date
2025-06-30
Last Updated
2024-10-02
Healthy Volunteers
No
Conditions
Interventions
DTG 50 mg OD with food
Dolutegravir 50 mg once daily with food plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy
DTG 50 mg BID
Dolutegravir 50 mg BID plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy.
Locations (10)
Klang Hospital
Bangkok, Bangkok, Thailand
Bhumibol Adulyadej Hospital
Bangkok, Bangkok, Thailand
Infectious Disease, Chulalongkorn University
Bangkok, Bangkok, Thailand
Infectious Disease Taksin Hospital
Bangkok, Bangkok, Thailand
Infectious Disease Chonburi Hospital
Chon Buri, Changwat Chon Buri, Thailand
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Changwat Nonthaburi, Thailand
Infectious Disease Buddhachinaraj Phitsanulok Hospital
Phitsanulok, Changwat Phitsanulok, Thailand
Infectious Disease Chiangrai Prachanukroh Hospital
Chiang Rai, Chiangrai, Thailand
Chest Division, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
HIV-NAT, Thai Red Cross - AIDS Research Centre
Bangkok, Thailand