Dolutegravir

Generic Name
Dolutegravir
Brand Names
Dovato, Juluca, Tivicay, Triumeq
Drug Type
Small Molecule
Chemical Formula
C20H19F2N3O5
CAS Number
1051375-16-6
Unique Ingredient Identifier
DKO1W9H7M1
Background

Dolutegravir is an HIV-1 integrase inhibitor that blocks the strand transfer step of the integration of the viral genome into the host cell (INSTI). The effect of this drug has no homology in human host cells, which gives it excellent tolerability and minimal toxicity. Dolutegravir was developed by ViiV Healthcare and FDA-approved on August 12, 2013. On Nove...

Indication

Dolutegravir is indicated in combination with other antiretroviral agents for the treatment of patients with HIV-1 infection that comply with the characteristics of being adults or children aged 12 years and older and present at least a weight of 40 kg. The FDA combination therapy approval of dolutegravir and rilpivirine is indicated for adults with HIV-1 in...

Associated Conditions
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Associated Therapies
-
Clinical Trials
Related News

A Pilot Study of MONOtherapy of DOlutegravir in HIV-1 Virologically Suppressed Patients

First Posted Date
2015-10-09
Last Posted Date
2017-11-01
Lead Sponsor
Calmy Alexandra
Target Recruit Count
8
Registration Number
NCT02572947
Locations
🇨🇭

University Hospitals of Geneva, HIV unit, Geneva, Switzerland

Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen

First Posted Date
2015-10-02
Last Posted Date
2020-12-07
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
9
Registration Number
NCT02566707
Locations
🇳🇱

St. Elisabeth, Tilburg, Netherlands

🇳🇱

Rijstate, Arnhem, Netherlands

🇳🇱

Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands

and more 1 locations

Early Simplified: A Trial to Compare the Efficacy of Standard of Care Combination Antiretroviral Therapy With a Simplified Dolutegravir Monotherapy in Patients With a Primary HIV-1 Infection

First Posted Date
2015-09-16
Last Posted Date
2018-10-12
Lead Sponsor
University of Zurich
Target Recruit Count
101
Registration Number
NCT02551523
Locations
🇨🇭

University Hospital Zurich, University of Zurich, Zurich, Switzerland

HIV Reservoir Dynamics After Switching to Dolutegravir in Patients on a PI and 2 NRTI Based Regimen

Phase 4
Completed
Conditions
HIV-1
Interventions
Drug: PI
Drug: Dolutegravir
Drug: 2 NRTI
First Posted Date
2015-07-31
Last Posted Date
2017-06-14
Lead Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Target Recruit Count
44
Registration Number
NCT02513147
Locations
🇪🇸

Hospital Universitari Vall d'Hebron, Barcelona, Spain

Dolutegravir Impact on Residual Replication

Phase 4
Completed
Conditions
HIV
Interventions
Drug: dolutegravir
Other: Placebo
First Posted Date
2015-07-16
Last Posted Date
2017-11-20
Lead Sponsor
University of Melbourne
Target Recruit Count
40
Registration Number
NCT02500446
Locations
🇦🇺

Alfred Hospital, Prahran, Victoria, Australia

🇦🇺

Melbourne Sexual Health Centre, Carlton, Victoria, Australia

Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity

Phase 2
Withdrawn
Conditions
HIV/AIDS
Interventions
Drug: Darunavir/Cobicistat
Drug: Dolutegravir
First Posted Date
2015-07-16
Last Posted Date
2021-07-09
Lead Sponsor
Stanford University
Registration Number
NCT02499978
Locations
🇺🇸

University of Colorado, Aurora, Colorado, United States

🇺🇸

Stanford Univerity, Stanford, California, United States

Assessment of Dolutegravir Removed by Hemodialysis in HIV-infected Patients With End-stage Renal Disease

Phase 4
Completed
Conditions
HIV
Interventions
Drug: Dolutegravir
First Posted Date
2015-07-01
Last Posted Date
2015-10-01
Lead Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Target Recruit Count
5
Registration Number
NCT02487706
Locations
🇪🇸

Germans Trias i Pujol Hospital, Badalona, Barcelona, Spain

HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

First Posted Date
2015-05-07
Last Posted Date
2024-01-09
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Target Recruit Count
122
Registration Number
NCT02437110
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers

Not Applicable
Completed
Conditions
HIV
Hepatitis C
Interventions
Drug: dolutegravir
Drug: simeprevir
First Posted Date
2015-04-01
Last Posted Date
2021-03-17
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
25
Registration Number
NCT02404805
Locations
🇺🇸

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial

Phase 4
Completed
Conditions
Human Immunodeficiency Virus
Interventions
Drug: Dolutegravir
First Posted Date
2015-03-30
Last Posted Date
2020-01-28
Lead Sponsor
Erasmus Medical Center
Target Recruit Count
134
Registration Number
NCT02401828
Locations
🇳🇱

Erasmus Medical Center, Rotterdam, Zuid Holland, Netherlands

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