This is a stage II, randomized, open-label study describing the efficacy and safety of DTG 50 mg OD with food and DTG 50 mg BID plus 2NRTIs in HIV/TB co-infected ART-naïve, RIF-sensitive, and newly diagnosed with probable or confirmed pulmonary, pleural, or lymph node (LN) Mycobacterium TB (MTB) patients on RIF-containing first-line TB treatment.
The study is comprised of two different stages:
1. Stage1: assess the safety, tolerability, and pharmacokinetics (PK), of two different doses of dolutegravir co-administered with standard anti-TB treatment. Intensive PK of DTG will be performed at week 4. Interim analysis will be performed if all 40 cases completed 12 weeks and 24 weeks. Premature study termination will be set for
- proportion of HIV RNA < 50 copies/ml at week 24 between 2 group is different > 20%
- DTG 50 mg with food has geometric mean DTG Ctrough < 0.3 mg/L
If there is no premature study termination met, the study will move to stage 2. Stage 2 will only be recruited if two different doses of dolutegravir are well tolerated and safe. 2. Stage 2: 160 HIV/TB patients will be enrolled. They will be randomized to 2 groups (DTG 50 mg with food and DTG 50 mg BID). DTG concentration will be performed at week 4 and 48. Interim analysis will be performed if all 200 cases completed 24 weeks.
