drugset / Trial / NCT06497465
Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |