A Phase 3 interventional study of Dolutegravir 50mg Tab and Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO] in Tuberculosis and HIV, sponsored by Johns Hopkins University. Recruiting at 5 sites in Brazil. Open to participants aged 15 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Johns Hopkins University · Phase 3, Interventional, and Treatment
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
Tuberculosis (TB) is the most common cause of death in people with HIV worldwide. Among patients with HIV, the incidence of TB per year is about 5-10%. The two diseases are now always treated concurrently in co-infected individuals, as there is a survival benefit for starting antiretroviral therapy (ART) soon after TB treatment initiation. Current Brazilian guidelines suggest that for patients with a cluster of differentiation 4 (CD4) \< 50, ART should be started within 2 weeks of starting TB treatment; for patients with a CD4>50, ART should be started within 2 months of starting TB treatment. World Health Organization guidelines suggest ART initiation within 2 weeks of TB diagnosis regardless of CD4 count (provided there are no signs of TB meningitis), but most programs defer ART until 6-8 weeks in patients with CD4 >50 to reduce the risk of immune reconstitution inflammatory syndrome (IRIS).
The option of dual therapy for HIV (i.e., complete regimens to treat HIV composed of only 2 drugs) is of increasing interest and can lower costs for patients, payors, and programs while lowering cumulative lifetime exposure to ART (with potential resultant lessened burden of cumulative toxicities) and maintaining high antiviral efficacy. Based on the GEMINI, TANGO, and SALSA clinical trials, a regimen of 50 milligram (mg) DTG combined with 300mg lamivudine (3TC) has been shown to be a highly effective stand-alone option for the treatment of HIV-1 in ART treatment-naïve or virologically suppressed individuals through 48 weeks (SALSA) and 144 weeks (GEMINI and TANGO).
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1: DTG 50mg/3TC 300 mg fixed-dose-combination (FDC) tablet (Dovato®) twice daily during TB therapy and for 2 weeks after, then DTG 50mg/3TC 300 mg FDC tablet (Dovato®) once daily to week 52
Drug: Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]
Arm 2: DTG 50mg/300mg FDC tablet plus DTG 50mg at night during TB treatment and for 2 weeks after, then DTG 50 mg/ 3TC 300 mg FDC tablet (Dovato®) once daily to week 52
Drug: Dolutegravir 50mg Tab · Drug: Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]
Arm 3: Local Standard of Care 3-drug ART (DTG 50mg + TDF/3TC) plus DTG 50 mg at night during TB treatment and for 2 weeks after, then DTG 50 mg + TDF/3TC FDC tablet once daily to week 52
Drug: Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
Participants will receive Dolutegravir 50mg
Also known as: TIVICAY 50 mg, TIVICAY PD
Drug pages: Dolutegravir · Dolutegravir Sodium/Lamivudine
Participants will receive Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet \[DOVATO\]
Drug pages: Dolutegravir · Tenofovir · Lamivudine
Participants will receive Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
Among treatment-naïve participants with HIV-1 who are taking rifampin-based regimens for TB, determine the proportion with HIV-1 virologic suppression (via FDA snapshot algorithm) at 28 weeks of HIV treatment, by arm
To Compare the proportion of participants with HIV-1 virologic suppression at 28 weeks of HIV treatment by arm.
Time frame: 28 weeks
1.3.1 Number of patients with HIV-1 virologic suppression (via FDA snapshot algorithm) at 48 weeks, in each arm
To compare the proportion in each arm above DTG protein adjusted 90% inhibitory concentration (IC90) (64 ng/mL) at each PK sampling.
Time frame: 48 weeks
1.3.2 Number of patients with HIV-1 virologic suppression at 48 weeks, in the combined DTG/3TC arms (Arm 1 + Arm 2)
To compare the proportion of patients with HIV-1 virologic suppression at 48 weeks, in the combined DTG/3TC arms (Arm 1 + Arm 2)
Time frame: 48 weeks
1.3.3 Change from baseline in CD4 over 28 weeks and 48 weeks of HIV treatment, by arm
To compare the changes from baseline over 28 weeks and 48 weeks of HIV treatment by the arm.
Time frame: 28 weeks, 48 weeks
1.3.4 Proportion of participants with DTG Cmin above target DTG trough of 158 ng/mL
1-To estimate the pharmacokinetics (PK) of DTG when given twice daily as a 50 mg/ 300 mg DTG/3TC FDC with rifampicin (RIF)-containing TB treatment, X DTG 50 mg/ 3TC 300 mg FDC given once daily without RIF among the same participants after completing TB treatment.
Time frame: 2years
1.3.4 Concentration of the PK of DTG
Concentration of DTG when given twice daily as a 50 mg/ 300 mg DTG/3TC FDC with RIF-containing TB treatment, X DTG 50 mg/ 3TC 300 mg FDC given once daily without RIF among the same participants after completing TB treatment.
Time frame: 2years
1.3.5 Compare Grade 3 or 4 adverse events, by arm
To compare the Grade 3 \& 4 adverse events by arm
Time frame: 2 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Dolutegravir · Dolutegravir Sodium/Lamivudine