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RECRUITING
NCT06497465
PHASE3

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

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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

DRUG

Dolutegravir 50mg Tab

Participants will receive Dolutegravir 50mg

DRUG

Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]

Participants will receive Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet \[DOVATO\]

DRUG

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