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
-

Dolutegravir and Darunavir Evaluation in Adults Failing Therapy

Phase 4
Active, not recruiting
Conditions
Interventions
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

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

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
Interventions
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

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
Interventions
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

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
Interventions
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

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

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