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Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
Sponsor: Johns Hopkins University
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
Official title: 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
Key Details
Gender
All
Age Range
15 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-09-18
Completion Date
2029-01-31
Last Updated
2025-09-24
Healthy Volunteers
No
Conditions
Interventions
Dolutegravir 50mg Tab
Participants will receive Dolutegravir 50mg
Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]
Participants will receive Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet \[DOVATO\]
Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
Participants will receive Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
Locations (6)
Instituto Tropical de Doenças Infecciosas Manaus
Manaus, Amazonas, Brazil
Universidade Federal da Bahia
Salvador, Estado de Bahia, Brazil
FIOCruz
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Geral de Nova Iguaçu
Rio de Janeiro, Rio de Janeiro, Brazil
CePClin - Center for Studies and Research in Infectious Diseases Ltda
Natal, Rio Grande do Norte, Brazil
RDSS- Ricardo Diaz Solucoes Cientificas
São Paulo, São Paulo, Brazil