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

Dolutegravir and Darunavir Evaluation in Adults Failing Therapy

Phase 4

Active, not recruiting

Conditions: HIV Infections

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

First Posted Date: 2017-01-11

Last Posted Date: 2023-04-18

Lead Sponsor: Kirby Institute

Target Recruit Count: 831

Registration Number: NCT03017872

Locations: 🇦🇷
Hospital G de Agudos JM Ramos Mejia, Buenos Aires, Ciudad De Buenos Aires, Argentina
🇦🇷
Hospital Dr Diego Paroissien, Isidro Casanova, Provincia De Buenos Aires, Argentina
🇦🇷
CAICI, Rosario, Provincia De Santa Fe, Argentina

and more 25 locations

National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection

Phase 3

Completed

Conditions: HIV-1 Infection

Interventions: Drug: Darunavir-cobicistat
Drug: Dolutegravir
Drug: Emtricitabine-Tenofovir

First Posted Date: 2016-12-09

Last Posted Date: 2022-01-04

Lead Sponsor: ANRS, Emerging Infectious Diseases

Target Recruit Count: 101

Registration Number: NCT02987530

Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection

Phase 3

Completed

Conditions: HIV Infection Primary

Interventions: Drug: Dolutegravir

First Posted Date: 2016-11-29

Last Posted Date: 2019-10-30

Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Target Recruit Count: 20

Registration Number: NCT02976259

Multi Interventional Study Exploring HIV-1 Residual Replication: a Step Towards HIV-1 Eradication and Sterilizing Cure

Not Applicable

Completed

Conditions: HIV
Chronic Infection

Interventions: Drug: Maraviroc
Drug: Dolutegravir
Biological: Dendritic Cell Vaccine
Drug: Sirtuin Histone deacetylase inhibitor
Drug: Auranofin

First Posted Date: 2016-11-11

Last Posted Date: 2020-07-28

Lead Sponsor: Federal University of São Paulo

Target Recruit Count: 30

Registration Number: NCT02961829

Locations: 🇧🇷
CCDI, Sao Paulo, SP, Brazil

Dolutegravir in Reservoirs

Phase 4

Terminated

Conditions: HIV

Interventions: Drug: dolutegravir
Drug: Triumeq
Drug: Truvada

First Posted Date: 2016-10-05

Last Posted Date: 2022-12-29

Lead Sponsor: Emory University

Target Recruit Count: 22

Registration Number: NCT02924389

Locations: 🇺🇸
Grady Health System, Atlanta, Georgia, United States
🇺🇸
Ponce De Leon Center, Atlanta, Georgia, United States
🇺🇸
Emory University, Atlanta, Georgia, United States

A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

Phase 1

Completed

Conditions: Infection, Human Immunodeficiency Virus

Interventions: Drug: BMS955176
Drug: Dolutegravir

First Posted Date: 2016-03-22

Last Posted Date: 2017-01-19

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 14

Registration Number: NCT02715479

Locations: 🇺🇸
GSK Investigational Site, Austin, Texas, United States

Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection

Phase 4

Active, not recruiting

Conditions: HIV

Interventions: Drug: Dolutegravir
Drug: Emtricitabine/Tenofovir

First Posted Date: 2016-01-15

Last Posted Date: 2024-05-08

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 74

Registration Number: NCT02656511

Locations: 🇺🇸
San Francisco General Hospital, San Francisco, California, United States

Study to Evaluate the Efficacy of MONotherapy of TiviCAY® Versus a Triple Therapy in HIV-1-infected Patients

Phase 3

Terminated

Conditions: HIV

Interventions: Drug: dolutegravir 50mg +abacavir 600mg +lamivudine 300mg
Drug: dolutegravir

First Posted Date: 2015-11-04

Last Posted Date: 2018-11-13

Lead Sponsor: Centre Hospitalier Régional d'Orléans

Target Recruit Count: 158

Registration Number: NCT02596334

Locations: 🇫🇷
CH de NIORT, Niort, France
🇫🇷
CH de LA ROCHELLE, La Rochelle, France
🇫🇷
CHD de VENDEE, La Roche sur Yon, France

and more 6 locations

Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients

Phase 2

Completed

Conditions: HIV-1 Infection

Interventions: Drug: Dolutegravir
Drug: Lamivudine

First Posted Date: 2015-10-21

Last Posted Date: 2018-05-09

Lead Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Target Recruit Count: 122

Registration Number: NCT02582684

Locations: 🇺🇸
University of Southern California CRS (1201), Los Angeles, California, United States
🇺🇸
UCLA CARE Center CRS (601), Los Angeles, California, United States
🇺🇸
Harbor-UCLA Med. Ctr. CRS (603), Torrance, California, United States

and more 23 locations

Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis

Phase 2

Completed

Conditions: HIV Infections
Tuberculosis

Interventions: Drug: Bedaquiline
Drug: Delamanid
Drug: Dolutegravir
Drug: Multidrug Background Treatment (MBT) for TB

First Posted Date: 2015-10-21

Last Posted Date: 2022-01-27

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 84

Registration Number: NCT02583048

Locations: 🇵🇪
Barranco CRS, Lima, Peru
🇿🇦
Task Applied Science (TASK) CRS, Cape Town, Western Cape Province, South Africa
🇿🇦
South African Tuberculosis Vaccine Initiative (SATVI) CRS, Cape Town, Western Cape Province, South Africa

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy