This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Dosed at 50 mg bd on 3 separate occasions with low, medium and high doses of rifampicin. Dosed at 50 mg od without rifampicin.
Desmond Tutu Health Foundation
Cape Town, South Africa
Infectious Diseases Institute
Kampala, Uganda
Change in pharmacokinetic parameter Cmin of dolutegravir
Change in dolutegravir Cmin when dosed with standard, medium, high dose rifampicin
Time frame: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Change in pharmacokinetic parameter AUC of dolutegravir
Change in dolutegravir AUC when dosed with standard, medium, high dose rifampicin
Time frame: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Change in pharmacokinetic parameter Cmax of dolutegravir
Change in dolutegravir Cmax when dosed with standard, medium, high dose rifampicin
Time frame: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Number of participants with Grade 3 and above adverse events as assessed by DAIDS (corrected v2.1 July 2017)
Number of participants with Grade 3 and above adverse events as assessed by DAIDS (corrected v2.1 July 2017)
Time frame: From first dose of dolutegravir until study completion approximately 2 years
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