Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
Recruiting now · Phase 3
Conditions studied: Tuberculosis, HIV
In brief
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
Key facts
- Study ID
- NCT06497465
- Run by
- Johns Hopkins University
- People needed
- 150
- Starts
- 2025-09-18
- Expected to finish
- 2029-01-31
- Last updated by the study team
- 2025-09-24
Who can join
Age: 15 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Pregnant, or plans to become pregnant.
Where it is running
- Instituto Tropical de Doenças Infecciosas Manaus — Manaus, Amazonas, Brazil (enrolling)
- Universidade Federal da Bahia — Salvador, Estado de Bahia, Brazil (enrolling)
- FIOCruz — Rio de Janeiro, Rio de Janeiro, Brazil (enrolling)
- Hospital Geral de Nova Iguaçu — Rio de Janeiro, Rio de Janeiro, Brazil (enrolling)
- CePClin - Center for Studies and Research in Infectious Diseases Ltda — Natal, Rio Grande do Norte, Brazil (enrolling)
- RDSS- Ricardo Diaz Solucoes Cientificas — São Paulo, São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.