Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment

This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice daily or DTG/3TC ( Dovato) in the morning +dolutegravir (DTG) in the evening, versus standard of care (SOC) twice-daily dolutegravir plus 2 once-daily Nucleoside reverse-transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate /lamivudine (TDF/3TC), among antiretroviral therapy (ART)-nave individuals with HIV-1 receiving rifampin-based TB therapy

NCT Number	NCT06497465
Lead Sponsor	Johns Hopkins University Collaborators: ViiV Healthcare
Conditions	Tuberculosis, HIV
Enrollment	150 participants
Start Date	2025-09-18
Primary Completion	2028-01-31 (estimated)
Study Completion	2029-01-31 (estimated)
Updated on ClinicalTrials.gov	2025-09-24