NCT06497465RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 4 Jul 2024
- Start date
- 18 Sept 2025
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT06497465
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 150
- From 18 Sept 2025 to the primary completion date, 31 Jan 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Pregnant, or plans to become pregnant.
Who the study is looking for
- 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 identified by:
- At least one sputum specimen positive for M. tuberculosis by molecular TB assay (Xpert) or line probe assay \[LPA\]), and RIF resistance not detected.
- OR Culture positive for MTB OR Positive Urinary Lipoarabinomannan (LAM) testing OR Clinical diagnosis of tuberculosis with no microbiological confirmation
Age in the registry: 15 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Tropical de Doenças Infecciosas Manaus Coordinator of this site? Confirm its status | Manaus | Brazil | Recruiting |
| CePClin - Center for Studies and Research in Infectious Diseases Ltda Coordinator of this site? Confirm its status | Natal | Brazil | Recruiting |
| FIOCruz Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Hospital Geral de Nova Iguaçu Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Universidade Federal da Bahia Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.