Dovato 50 mg/300 mg film-coated tablets
Sponsors
Viiv Healthcare UK Limited, Fundacion Seimc Gesida, Universitair Ziekenhuis Gent, Universitair Ziekenhuis Gent, Societa Italiana Di Malattie Infettive E Tropicali SIMIT, Societa Italiana Di Malattie Infettive E Tropicali SIMIT, Fondazione Penta Ets
Conditions
HIVHIV InfectionsHIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA <50 copies/mLHIV-1 infectionHIV-infectedHuman immunodeficiency virus (HIV)human immunodeficiency viruses (HIV)
Phase 2
Phase 3
A Phase 3b, multicenter, single-arm, open-label study evaluating the efficacy, safety, and tolerability of switching to DTG/3TC single tablet regimen administered once daily from a bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen in people living with HIV of at least 50 years of age who are virologically suppressed
Active, not recruitingCTIS2022-503137-66-00
Start: 2023-11-29Target: 117Updated: 2025-11-23
A Phase IIIb, multi-center, non-randomized, parallel-group, open-label, hybrid type I study evaluating the efficacy, safety, implementation effectiveness, and patient-reported outcomes of oral dolutegravir/lamivudine once-daily as a first-line regimen followed by participant-determined optional switch to long-acting intramuscular cabotegravir plus rilpivirine every two months for the maintenance of virologic suppression in antiretroviral therapy naive adults living with HIV-1.
Active, not recruitingCTIS2023-503893-19-00
Start: 2023-12-06Target: 67Updated: 2025-12-29
A Phase 3b, multi-center, randomized, parallel-group, open-label, non-inferiority study evaluating the efficacy, safety, and tolerability of oral dolutegravir/lamivudine once-daily as a first-line regimen compared to oral bictegravir/emtricitabine/tenofovir alafenamide once daily for virologic suppression and maintenance in antiretroviral therapy naive adults living with HIV
Active, not recruitingCTIS2023-504993-40-00
Start: 2024-02-14Target: 378Updated: 2025-04-04
DTG/3TC vs BIC/FTC/TAF maintenance therapy in people living with HIV: an open-label randomized clinical trial
CompletedCTIS2024-515167-56-00
Start: 2021-06-22End: 2025-03-13Target: 555Updated: 2025-06-04
Efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) from INSTI-based three-drug regimens in HIV-1-infected adults previously naïve who achieve virological suppression
Active, not recruitingCTIS2024-518909-18-00
Start: 2021-03-23Target: 440Updated: 2024-12-16
A randomised non-inferiority trial with nested PK to assess DTG/3TC fixed dose formulations for the maintenance of virological suppression in children with HIV infection aged 2 to <15 years old
Active, not recruitingCTIS2024-520388-15-00
Start: 2023-06-30Target: 6Updated: 2025-08-12
Phase 4
Phase IV, Randomized, Multicenter, Double-Blind Clinical Trial Designed to Evaluate the Safety and Appropriateness of Switching from DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control, and Neuropsychiatric Vulnerabilities: MIND Study
CompletedCTIS2024-511951-16-00
Start: 2022-08-30End: 2024-08-07Target: 84Updated: 2024-05-13
Virological and immunological assessment in HIV positive participants on 2DR versus 3DR in a prospective randomized controlled switch trial.
Active, not recruitingCTIS2024-515265-34-00
Start: 2020-05-26Target: 134Updated: 2024-10-09