Johns Hopkins University
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
HIV
Dolutegravir 50mg Tab
Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]
Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
PHASE3
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).
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 150 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| 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 |
| Actual Study Start Date : | 2025-01-31 |
| Estimated Primary Completion Date : | 2028-01-31 |
| Estimated Study Completion Date : | 2029-01-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 15 Years to 99 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Tropical Institute of Infectious Diseases Manaus
Manaus, AM, Brazil, 69040-000
Not yet recruiting
Federal University of Bahia
Salvador, BA, Brazil, 40110-160
Not yet recruiting
FIOCruz
Rio de Janeiro, RJ, Brazil, 21040-360
Not yet recruiting
Nova Iguaçu General Hospital
Rio de Janeiro, RJ, Brazil, 26210-190
Not yet recruiting
RDSS - Ricardo Diaz Scientific Solutions
São Paulo, SP, Brazil, 04037-030