Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
Dolutegravir Plus Lamivudine (DTG/3TC) Dual Therapy Versus Dolutegravir With TDF-lamivudine (DTG + TDF/3TC) Among Antiretroviral naïve People With HIV and TB Receiving Rifampin-based TB Treatment
Johns Hopkins University
150 participants
Sep 18, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria5
- Documentation of HIV-1 status: HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV 1 RNA viral load. Two or more HIV-1 RNA viral loads of \>1,000 copies/mL are also acceptable as documentation of HIV-1 infection.
- CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry
- HIV-1 viral load ≥1000 copies/mL
- ART-naïve.
- Documentation of pulmonary TB
Exclusion Criteria1
- Pregnant, or plans to become pregnant.
Interventions
Participants will receive Dolutegravir 50mg
Participants will receive Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet \[DOVATO\]
Participants will receive Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06497465