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

NCT06497465

RecruitingPhase 3

Sponsor: Johns Hopkins University

Conditions: Tuberculosis, HIV

Interventions: Dolutegravir 50mg Tab, Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO], Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)

Countries: Brazil

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 overview

Sex: ALL

Age: 15 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* Pregnant, or plans to become pregnant.
Locations (6)
  • Manaus, Amazonas, Brazil
  • Salvador, Estado de Bahia, Brazil
  • Rio de Janeiro, Rio de Janeiro, Brazil
  • Rio de Janeiro, Rio de Janeiro, Brazil
  • Natal, Rio Grande do Norte, Brazil
  • São Paulo, São Paulo, Brazil