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Last Updated: January 27, 2023

CLINICAL TRIALS PROFILE FOR DOVATO


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All Clinical Trials for Dovato

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03945981 ↗ Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults Completed ViiV Healthcare Phase 3 2019-07-02 Early initiation of antiretroviral therapy (ART) reduces morbidity and mortality for individuals infected with HIV. Suppressing viral replication with ART also reduces the potential for transmission of HIV. Hence, ART is recommended for all persons with HIV viremia regardless of cluster of differentiation 4 (CD4) count. This is an open-label single arm which will evaluate the feasibility, efficacy and safety using a fixed dose combination (FDC) of Dolutegravir (DTG) plus Lamivudine (3TC) as a first line regimen of a rapid Test and Treat model of care over 48 weeks. Participants with new and confirmed diagnosed HIV-1 who are willing to start study treatment immediately following diagnosis will receive 50 milligram (mg) DTG + 300 (mg) 3TC FDC as first line therapy without waiting for screening laboratory results, at the Screening/Day 1 Visit. The total duration for the study will be 52 weeks and 4 weeks of follow up period if required. This study will be conducted in United States (US) with approximately 120 participants.
NCT04553081 ↗ 2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial Active, not recruiting ViiV Healthcare Phase 4 2020-05-26 The aim of this study is to monitor virological and immunological markers in participants who are switching from a classic triple drug regimen (3DR) to dual therapy (2DR). We aim to monitor whether this has an influence on different parameters such as severity of HIV disease (evaluated by viral load and viral reservoir size), presence of non-AIDS related health complications, impact the phenotype and function of the immune system. By conducting this study we want to assess whether switching from 3DR to 2DR implies an increased risk for 'subclinical' failure. We especially want to make sure that this switch does not increase the HIV reservoir, does not increase inflammation or immune exhaustion in patients living with HIV and that it can be considered as a safe long term alternative for the classic 3DR. The primary objective is to demonstrate non inferiority at W48 of the 2DR DTG/3TC (Dovato) regimen compared to BIC/TAF/FTC (Biktarvy) in terms of the amount of intact replication competent HIV sequences with a non-inferiority margin of 12% quantified by the fraction intact HIV viral sequences quantified by IPDA, present in blood CD4 cells.
NCT04553081 ↗ 2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial Active, not recruiting University Hospital, Ghent Phase 4 2020-05-26 The aim of this study is to monitor virological and immunological markers in participants who are switching from a classic triple drug regimen (3DR) to dual therapy (2DR). We aim to monitor whether this has an influence on different parameters such as severity of HIV disease (evaluated by viral load and viral reservoir size), presence of non-AIDS related health complications, impact the phenotype and function of the immune system. By conducting this study we want to assess whether switching from 3DR to 2DR implies an increased risk for 'subclinical' failure. We especially want to make sure that this switch does not increase the HIV reservoir, does not increase inflammation or immune exhaustion in patients living with HIV and that it can be considered as a safe long term alternative for the classic 3DR. The primary objective is to demonstrate non inferiority at W48 of the 2DR DTG/3TC (Dovato) regimen compared to BIC/TAF/FTC (Biktarvy) in terms of the amount of intact replication competent HIV sequences with a non-inferiority margin of 12% quantified by the fraction intact HIV viral sequences quantified by IPDA, present in blood CD4 cells.
NCT04585737 ↗ Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF Recruiting ViiV Healthcare Phase 4 2020-09-22 Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dovato

Condition Name

Condition Name for Dovato
Intervention Trials
HIV Infections 3
HIV-1-infection 2
HIV I Infection 1
HIV Lipodystrophy 1
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Condition MeSH

Condition MeSH for Dovato
Intervention Trials
HIV Infections 4
Acquired Immunodeficiency Syndrome 3
Weight Gain 1
Renal Insufficiency 1
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Clinical Trial Locations for Dovato

Trials by Country

Trials by Country for Dovato
Location Trials
Italy 15
United States 11
Denmark 1
Belgium 1
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Trials by US State

Trials by US State for Dovato
Location Trials
Texas 2
Florida 2
New Jersey 1
North Carolina 1
Missouri 1
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Clinical Trial Progress for Dovato

Clinical Trial Phase

Clinical Trial Phase for Dovato
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Dovato
Clinical Trial Phase Trials
Recruiting 3
Completed 2
Not yet recruiting 1
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Clinical Trial Sponsors for Dovato

Sponsor Name

Sponsor Name for Dovato
Sponsor Trials
ViiV Healthcare 5
University Hospital, Ghent 1
Charlotte-Paige Rolle, MD 1
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Sponsor Type

Sponsor Type for Dovato
Sponsor Trials
Industry 5
Other 5
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