Study of Dolutegravir and Lamivudine Dual Therapy Versus Standard Three-Drug Treatment for People With HIV and Tuberculosis Receiving Rifampin-Based TB Treatment

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and tolerability of a dual therapy regimen of dolutegravir plus lamivudine given either twice daily or as a combination in the morning plus dolutegravir in the evening, compared to the standard three-drug antiretroviral therapy ART in people living with HIV-1 who have not previously received ART and are also being treated for tuberculosis TB with rifampin-based therapy. This Phase IIIb international, multicenter, randomized trial aims to find better treatment options for patients co-infected with HIV and TB, conditions that commonly occur together and require concurrent treatment to improve survival. Participants will be randomly assigned to one of three treatment groups Arm 1 receives the fixed-dose combination tablet of dolutegravir 50 mg and lamivudine 300 mg twice daily during TB therapy and for two weeks after, then once daily through week 52. Arm 2 receives the same tablet once daily in the morning plus dolutegravir 50 mg at night during TB treatment and for two weeks after, followed by once daily dosing of the combination tablet through week 52. Arm 3 receives the local standard care of dolutegravir 50 mg plus tenofovir disoproxil fumaratelamivudine once daily during TB therapy and for two weeks after, then continuing the same once daily through week 52. During the study, participants will be monitored for HIV viral load suppression at 28 weeks and 48 weeks, changes in CD4 cell counts, and drug concentration levels over two years. Safety will be assessed by tracking adverse events. The trial includes laboratory tests and clinical assessments to evaluate efficacy and tolerability, with follow-up extending to 52 weeks for treatment and two years for safety monitoring. This comprehensive evaluation helps understand how well the dual therapy works compared to standard treatment in this population.

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