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

Study acronym: DOVETAIL
StatusRecruiting
PhasePhase 3
Started2025-09-18
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Status, Eligibility, Contacts/Locations v11
Study sites6→5
Eligibility criteria+319 characters
[...] oad ≥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 confirmat [...] Exclusion Criteria: Pregnant, or plans to become pregnant.
2025-09-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v10
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09→confirmed 2025-09-18
Study sitesdetails revised at 6 of 6 sites
2025-09-02
Study Status v9
Start date2025-09-01→2025-09
2025-08-25
Study Status v8
Start date2025-08-01→2025-09-01
2025-07-10
Study Status v7
Start date2025-07-14→2025-08-01
Show 6 earlier versions
2025-07-01
Study Status, Contacts/Locations v6
Study sites5→6
2025-06-10
Study Status v5
Start date2025-06-14→2025-07-14
2025-04-08
Study Status v4
Start date2025-04-14→2025-06-14
2025-01-08
Study Status, Arms and Interventions v3
Start date2025-01-31→2025-04-14
InterventionsDolutegravir 50mg Tab (Drug), Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC) (Drug), Dolutegravir/Lamivudine 50…→Dolutegravir 50mg Tab (Drug), Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC) (Drug), Dolutegravir/Lamivudine 50…
2024-12-12
Study Status, Contacts/Locations v2
Study sites8→5
2024-07-11
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
Eligibility criteria+2 characters
[...] d HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to entry and confirmed by a lice [...]
Secondary endpointsdetails revised at 2 of 6 entries
Study description+66 characters
[...] rrent Brazilian guidelines suggest that for patients with a cluster of differentiation 4 (CD4) < 50, ART should be started within 2 weeks of starting TB t [...] should be started within 2 months of starting TB treatment.1WHO World Health Organization guidelines suggest ART initiation within 2 weeks of TB diagn [...] the GEMINI, TANGO, and SALSA clinical trials, a regimen of 50mg50 milligram (mg) DTG combined with 300mg lamivudine (3TC) has been shown to [...]
2024-07-04
Original filing
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
Trial Details
NCT Number NCT06497465
Lead Sponsor Johns Hopkins University
Collaborators: ViiV Healthcare
Conditions Tuberculosis, HIV
Enrollment 150 participants
Start Date 2025-09-18
Primary Completion 2028-01-31 (estimated)
Study Completion 2029-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-11