Dolutegravir plus lamivudine two-drug HIV treatment for people starting 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
Run by Johns Hopkins University · NCT06497465 · Data updated 2026-11-12
This will test whether a two-drug HIV regimen (dolutegravir plus lamivudine), given either twice daily or as Dovato in the morning plus extra dolutegravir in the evening, works and is safe for ART‑naïve people with HIV who are receiving rifampin-based tuberculosis treatment compared with standard three‑drug therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 15 Years to 99 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 5 sites (Manaus, Amazonas and 4 other locations) |
| Status | Recruiting |
| Started | September 18, 2025 |
| Main results expected | January 31, 2028 |
| Study ends | January 31, 2029 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT06497465 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with HIV‑1 who are ART‑naïve, have CD4 count ≥50 cells/mm3, HIV RNA ≥1,000 copies/mL, documented pulmonary TB, and are receiving rifampin-based TB therapy are the intended participants.
✕Probably not a fit
People who are pregnant or planning pregnancy, already on ART, or otherwise excluded by the protocol would not be expected to benefit from participation in this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an international, multicenter, randomized, three-arm Phase IIIb trial comparing two dolutegravir/lamivudine (DTG+3TC) dosing strategies against standard-of-care dolutegravir plus tenofovir disoproxil fumarate/lamivudine in ART‑naïve adults with HIV and documented pulmonary TB who are receiving rifampin-based TB therapy. Participants are randomized to (1) DTG+3TC twice daily, (2) Dovato (DTG/3TC) in the morning plus an extra DTG in the evening, or (3) SOC twice-daily DTG plus once-daily TDF/3TC, with follow-up for virologic efficacy, safety, and tolerability. The design addresses the drug–drug interaction between rifampin and dolutegravir by using adjusted DTG dosing schedules. Trial sites include multiple centers in Brazil and outcomes will inform whether a simplified two‑drug regimen can be used during concurrent TB treatment.
Why it matters
Potential benefit: If successful, this could offer a simpler, lower‑exposure HIV regimen that remains effective during rifampin-based TB treatment, reducing pill burden and long‑term toxicity.
How similar studies have gone: Large trials such as GEMINI, TANGO, and SALSA have shown DTG+3TC is highly effective in many people without TB, but using this two‑drug approach alongside rifampin-based TB treatment is less well tested and is the focus of this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Instituto Tropical de Doenças Infecciosas Manaus
Manaus, Amazonas, Brazil Recruiting -
Universidade Federal da Bahia
Salvador, Estado de Bahia, Brazil Recruiting -
FIOCruz
Rio de Janeiro, Rio de Janeiro, Brazil Recruiting -
Hospital Geral de Nova Iguaçu
Rio de Janeiro, Rio de Janeiro, Brazil Recruiting -
CePClin - Center for Studies and Research in Infectious Diseases Ltda
Natal, Rio Grande do Norte, Brazil Recruiting
Study contacts
- Principal investigator: Ethel M Weld, MD — Johns Hopkins University
- Study coordinator: Beatriz M Kohler, RN
- Email: bkohler@jhmi.edu
- Phone: 410 614 3812
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.