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
- -
Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir
- Conditions
- Interventions
- First Posted Date
- 2015-01-13
- Last Posted Date
- 2018-08-03
- Lead Sponsor
- Juan A. Arnaiz
- Target Recruit Count
- 104
- Registration Number
- NCT02337322
- Locations
- 🇪🇸
Hospital Clinic of Barcelona, Barcelona, BCN, Spain
Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure
- Conditions
- Interventions
- First Posted Date
- 2014-10-13
- Last Posted Date
- 2019-10-14
- Lead Sponsor
- Babafemi Taiwo
- Target Recruit Count
- 89
- Registration Number
- NCT02263326
- Locations
- 🇺🇸
University of California San Diego, San Diego, California, United States
🇺🇸Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸University of Cincinnati, Cincinnati, Ohio, United States
Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults
- Conditions
- Interventions
- First Posted Date
- 2014-08-18
- Last Posted Date
- 2018-12-26
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Target Recruit Count
- 20
- Registration Number
- NCT02218320
- Locations
- 🇺🇸
Clinical and Translational Research Center, UNC Hospitals, Chapel Hill, North Carolina, United States
Cardiovascular Risk in HIV Patients Switching From a Boosted Protease Inhibitor (PI) to Dolutegravir (DTG)
- First Posted Date
- 2014-03-28
- Last Posted Date
- 2018-04-09
- Lead Sponsor
- St Stephens Aids Trust
- Target Recruit Count
- 415
- Registration Number
- NCT02098837
- Locations
- 🇫🇷
Hopital Saint Louis, Paris, France
🇩🇪Universitätsklinikum Essen, Essen, Germany
🇪🇸Universitario Alicante, Alicante, Spain
A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany
- First Posted Date
- 2014-03-03
- Last Posted Date
- 2018-08-13
- Lead Sponsor
- ViiV Healthcare
- Target Recruit Count
- 411
- Registration Number
- NCT02076386
- Locations
- 🇩🇪
GSK Investigational Site, Weimar, Germany
Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam
- Conditions
- Interventions
- First Posted Date
- 2013-04-09
- Last Posted Date
- 2014-04-09
- Lead Sponsor
- Tobira Therapeutics, Inc.
- Target Recruit Count
- 20
- Registration Number
- NCT01827540
- Locations
- 🇺🇸
SeaView Research, Inc., Miami, Florida, United States
Dolutegravir Expanded Access Study
- Conditions
- First Posted Date
- 2012-02-22
- Last Posted Date
- 2020-09-30
- Lead Sponsor
- ViiV Healthcare
- Target Recruit Count
- 200
- Registration Number
- NCT01536873
- Locations
- 🇵🇱
GSK Investigational Site, Szczecin, Poland
Drug Interaction Study Between Dolutegravir and an Oral Contraceptive Containing Norgestimate and Ethinylestradiol
- Conditions
- Interventions
- First Posted Date
- 2011-12-26
- Last Posted Date
- 2012-05-21
- Lead Sponsor
- ViiV Healthcare
- Target Recruit Count
- 16
- Registration Number
- NCT01498861
- Locations
- 🇺🇸
GSK Investigational Site, Miami, Florida, United States
A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects
- First Posted Date
- 2011-12-26
- Last Posted Date
- 2015-02-25
- Lead Sponsor
- ViiV Healthcare
- Target Recruit Count
- 13
- Registration Number
- NCT01499199
- Locations
- 🇺🇸
GSK Investigational Site, Providence, Rhode Island, United States
A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects
- Conditions
- Interventions
- First Posted Date
- 2011-11-08
- Last Posted Date
- 2012-10-15
- Lead Sponsor
- ViiV Healthcare
- Target Recruit Count
- 28
- Registration Number
- NCT01467531
- Locations
- 🇺🇸
GSK Investigational Site, Buffalo, New York, United States
Drug Development Updates
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