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RECRUITING
NCT03731559
PHASE2

Efficacy, Safety and Pharmacokinetics of DTG with RIF

Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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