Dolutegravir

Generic Name: Dolutegravir

Brand Names: Dovato, Juluca, Tivicay, Triumeq

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₁₉F_₂N_₃O_₅

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

Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana

Recruiting

Conditions: Lactating Women on Select DOI
Breastmilk Fed Infants of Mothers on Select DOI
HIV Infections

Interventions: Drug: Dolutegravir
Drug: Lamivudine
Drug: Emtricitabine
Drug: Tenofovir Disoproxil Fumarate

First Posted Date: 2021-04-28

Last Posted Date: 2024-02-29

Lead Sponsor: Duke University

Target Recruit Count: 200

Registration Number: NCT04862975

Locations: 🇿🇦
Botswana-UPenn Partnership, Botswana, Gaborone, South Africa
🇿🇦
Old Naledi Clinic, Botswana, Gaborone, South Africa
🇿🇦
Mogoditshane Clinic KDC, Botswana, Gaborone, South Africa

and more 1 locations

Gut Microbiota, PGx and INSTIs Response

Completed

Conditions: HIV Infections

Interventions: Drug: Bictegravir
Drug: Dolutegravir

First Posted Date: 2021-03-18

Last Posted Date: 2024-05-10

Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Target Recruit Count: 180

Registration Number: NCT04805944

Locations: 🇧🇪
Cliniques universitaires Saint-Luc, Brussels, Belgium

The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers

Phase 1

Completed

Conditions: HIV-1-infection on Healthy Volunteers

Interventions: Drug: Dolutegravir

First Posted Date: 2021-02-25

Last Posted Date: 2024-03-05

Lead Sponsor: Chelsea and Westminster NHS Foundation Trust

Target Recruit Count: 16

Registration Number: NCT04771754

Locations: 🇬🇧
Arnold Xhikola, London, United Kingdom

A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults

Phase 2

Terminated

Conditions: HIV Infections

Interventions: Drug: GSK3640254
Drug: ABC/3TC
Drug: FTC/TAF
Drug: Dolutegravir
Drug: Placebo

First Posted Date: 2020-07-30

Last Posted Date: 2024-06-26

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 161

Registration Number: NCT04493216

Locations: 🇨🇭
GSK Investigational Site, Zuerich, Switzerland

Dolutegravir in Real Life in Lesotho

Completed

Conditions: HIV-1-infection

Interventions: Drug: Dolutegravir

First Posted Date: 2020-01-23

Last Posted Date: 2023-05-23

Lead Sponsor: Swiss Tropical & Public Health Institute

Target Recruit Count: 1433

Registration Number: NCT04238767

Locations: 🇱🇸
Seboche Mission Hospital, Butha-Buthe, Lesotho
🇱🇸
Butha-Buthe Government Hospital, Butha-Buthe, Lesotho

Second-line Switch to Dolutegravir Study

Phase 4

Completed

Conditions: HIV-1-infection

Interventions: Drug: Dolutegravir

First Posted Date: 2020-01-18

Last Posted Date: 2022-01-27

Lead Sponsor: University of Nairobi

Target Recruit Count: 795

Registration Number: NCT04229290

Locations: 🇰🇪
Kiambu Level 5 Hospital, Kiambu, Kenya
🇰🇪
Jaramogi Oginga Odinga Teaching and Referral Hospital, Kisumu, Kenya
🇰🇪
Thika Level 5 Hospital, Thika, Kenya

and more 1 locations

Inflammation and Co-Infections in D²EFT

Phase 4

Withdrawn

Conditions: HIV-infection/Aids
Human Herpesvirus 4 Infections
Cytomegalovirus Infections
Human Herpesvirus 8 Infection
Human Papilloma Virus

Interventions: Drug: NRTIs
Drug: Darunavir
Drug: Ritonavir
Drug: Dolutegravir

First Posted Date: 2019-12-03

Last Posted Date: 2020-11-10

Lead Sponsor: Kirby Institute

Registration Number: NCT04183738

Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

Phase 4

Completed

Conditions: Hiv
Tuberculosis

Interventions: Drug: Dolutegravir

First Posted Date: 2019-11-18

Last Posted Date: 2024-08-13

Lead Sponsor: Helen Reynolds

Target Recruit Count: 36

Registration Number: NCT04166474

Locations: 🇿🇦
Desmond Tutu Health Foundation, Cape Town, South Africa
🇺🇬
Infectious Diseases Institute, Kampala, Uganda

Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Placebo
Drug: S-648414
Drug: Midazolam
Drug: Dolutegravir

First Posted Date: 2019-11-01

Last Posted Date: 2021-11-01

Lead Sponsor: Shionogi

Target Recruit Count: 98

Registration Number: NCT04147715

Locations: 🇯🇵
P-One Clinic, Hachioji City, Toyko, Japan
🇺🇸
PPD Ph 1 Clinical Research Unit, Austin, Texas, United States

ANRS 12372 MODERATO Study

Phase 3

Active, not recruiting

Conditions: HIV-1-infection

Interventions: Drug: tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovir
Drug: atazanavir boosted with ritonavir
Drug: dolutegravir
Drug: Lamivudine

First Posted Date: 2019-07-17

Last Posted Date: 2023-09-06

Lead Sponsor: ANRS, Emerging Infectious Diseases

Target Recruit Count: 480

Registration Number: NCT04022967

Locations: 🇨🇮
Service des Maladies Infectieuses et Tropicales (SMIT), CHU de Treichville, Abidjan, Côte D'Ivoire
🇧🇫
Service de médecine interne, CHU Yalgado Ouédraogo, Ouagadougou, Burkina Faso
🇧🇫
Hôpital de jour, Service des maladies infectieuses, CHU Sourô Sanou, Bobo-Dioulasso, Burkina Faso

and more 2 locations

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