drugset / Trial / NCT06497465

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

NCT06497465

Phase 3 Recruiting 150 enrolled Johns Hopkins University ViiV Healthcare · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2025-09-18
Primary completion
2028-01-31
Completion
2029-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dolutegravir Other / unclassified 50 mg
Subject Dolutegravir/Lamivudine Unknown 50 mg Oral
Subject Dolutegravir/Lamivudine Unknown 300 mg Oral
Comparator Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC) Unknown