RecruitingPhase 2NCT03731559

Efficacy, Safety and Pharmacokinetics of DTG with RIF

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


Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Enrollment

200 participants

Start Date

Jun 25, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether dolutegravir (DTG), an HIV medication, works effectively and safely when taken alongside rifampicin (RIF), an antibiotic commonly used to treat tuberculosis (TB), in people who have both HIV and TB. **You may be eligible if...** - You are HIV-positive and have never been on HIV treatment (or had less than 2 weeks of it) - You are 18 years or older - You have been diagnosed with TB and are taking rifampicin-based TB treatment - Your liver and kidney function are within acceptable ranges - Your weight is above 40 kg (about 88 lbs) - You do not have other serious active infections (besides oral thrush or disseminated MAC) **You may NOT be eligible if...** - You have been on HIV treatment for more than 2 weeks - You have significant liver problems (ALT more than 5 times the normal limit) - Your kidneys are not working well (eGFR below 60) - You are severely anemic (hemoglobin below 7 mg/L) - You have another serious active opportunistic infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDTG 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

DRUGDTG 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

View Full Details on ClinicalTrials.gov

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NCT03731559