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

NCT06497465 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-24

No results posted yet for this 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

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)

Sponsors & Collaborators

Principal Investigators

  • Ethel M Weld, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-18
Primary Completion
2028-01-31
Completion
2029-01-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06497465 on ClinicalTrials.gov