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Clinical Trials in Brazil / NCT06497465
Recruiting Phase 3

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

NCT06497465 · tracked via the Priya Life Science Brazil tracker
Sponsor
Johns Hopkins University
Phase
Phase 3
Started
2025-09-18
Last updated
2026-09-11

Condition(s) studied

TuberculosisHIV

Investigational drug(s) / intervention(s)

Dolutegravir 50mg Tab →Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO] →Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)All Dolutegravir trials (7) →All Gammora trials (6) →

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)

Study 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

Sex
ALL
Min age
15 Years
Max age
99 Years
Healthy volunteers
No
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 identified by: At least one sputum specimen positive for M. tuberculosis by molecular TB assay (Xpert) or line probe assay \[LPA\]), and RIF resistance not detected. OR Culture positive for MTB OR Positive Urinary Lipoarabinomannan (LAM) testing OR Clinical diagnosis of tuberculosis with no microbiological confirmation Exclusion Criteria: * Pregnant, or plans to become pregnant.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Instituto Tropical de Doenças Infecciosas Manaus Manaus Amazonas Recruiting
Universidade Federal da Bahia Salvador Estado de Bahia Recruiting
FIOCruz Rio de Janeiro Rio de Janeiro Recruiting
Hospital Geral de Nova Iguaçu Rio de Janeiro Rio de Janeiro Recruiting
CePClin - Center for Studies and Research in Infectious Diseases Ltda Natal Rio Grande do Norte Recruiting

Other trials for the same condition

Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV Recruiting
Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants Recruiting
Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals Recruiting
HIV Drug Resistance Among Individuals Failing Tenofovir/Lamivudine and Dolutegravir First Line Regimen in Brazil Active, not recruiting
A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06497465 on ClinicalTrials.gov ↗ ← All trials in Brazil