RecruitingPhase 3NCT06497465

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


Sponsor

Johns Hopkins University

Enrollment

150 participants

Start Date

Sep 18, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 15 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a simpler two-drug HIV treatment — dolutegravir plus lamivudine — is safe and effective for people with HIV who are also being treated for tuberculosis (TB) using the antibiotic rifampin. **You may be eligible if...** - You have confirmed HIV-1 infection (documented by standard HIV tests or viral load) - You have active tuberculosis (TB) and are currently being treated with a rifampin-based TB regimen - You are not yet on HIV treatment (antiretroviral therapy naïve) - You meet blood count and organ function requirements **You may NOT be eligible if...** - You have previously been on HIV treatment (antiretroviral drugs) - You have resistance to any of the study drugs - You are pregnant or planning to become pregnant - You have serious liver, kidney, or other health complications that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDolutegravir 50mg Tab

Participants will receive Dolutegravir 50mg

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

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

DRUGDolutegravir 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

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NCT06497465


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