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 Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
- Conditions
- Interventions
- First Posted Date
- 2024-02-28
- Last Posted Date
- 2024-08-19
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 25
- Registration Number
- NCT06281834
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
- Conditions
- Interventions
- First Posted Date
- 2023-08-07
- Last Posted Date
- 2024-08-19
- Lead Sponsor
- ViiV Healthcare
- Target Recruit Count
- 412
- Registration Number
- NCT05979311
- Locations
- 🇬🇧
GSK Investigational Site, London, United Kingdom
Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers
- Conditions
- Interventions
- First Posted Date
- 2022-12-15
- Last Posted Date
- 2024-12-20
- Target Recruit Count
- 120
- Registration Number
- NCT05652478
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Doravirine Dose Optimisation in Pregnancy
- First Posted Date
- 2022-11-29
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- University of Liverpool
- Target Recruit Count
- 76
- Registration Number
- NCT05630638
- Locations
- 🇿🇦
Desmond Tutu Health Foundation, Cape Town, South Africa
Pharmacokinetics and Safety of DolutegravIr in Neonate
- First Posted Date
- 2022-10-21
- Last Posted Date
- 2023-12-18
- Lead Sponsor
- Desmond Tutu TB Centre
- Target Recruit Count
- 56
- Registration Number
- NCT05590325
- Locations
- 🇿🇦
Tygerberg Hospital, Cape Town, Western Cape, South Africa
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir
- First Posted Date
- 2022-02-11
- Last Posted Date
- 2022-11-04
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 48
- Registration Number
- NCT05236530
- Locations
- 🇬🇧
Novartis Investigative Site, Belfast, Northern Ireland, United Kingdom
Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)
- First Posted Date
- 2021-11-17
- Last Posted Date
- 2024-03-18
- Lead Sponsor
- The Aurum Institute NPC
- Target Recruit Count
- 92
- Registration Number
- NCT05122767
- Locations
- 🇿🇦
The Aurum Institute: Pretoria Clinical Research Centre, Pretoria, Gauteng, South Africa
🇿🇦Peri Natal HIV Research Unit - Klerksdorp Tshepong Hospital, Klerksdorp, North-West, South Africa
Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV
- Conditions
- Interventions
- First Posted Date
- 2021-06-02
- Last Posted Date
- 2023-07-27
- Lead Sponsor
- Botswana Harvard AIDS Institute Partnership
- Target Recruit Count
- 140
- Registration Number
- NCT04910711
- Locations
- 🇧🇼
Princess Marina Hospital, Gaborone, Botswana
A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults
- Conditions
- Interventions
- First Posted Date
- 2021-05-25
- Last Posted Date
- 2023-12-14
- Lead Sponsor
- ViiV Healthcare
- Target Recruit Count
- 85
- Registration Number
- NCT04900038
- Locations
- 🇪🇸
GSK Investigational Site, Vigo, Spain
Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch
- Conditions
- Interventions
- First Posted Date
- 2021-05-19
- Last Posted Date
- 2023-10-25
- Lead Sponsor
- Chelsea and Westminster NHS Foundation Trust
- Target Recruit Count
- 150
- Registration Number
- NCT04892654
- Locations
- 🇬🇧
Mortimer Market Centre, London, United Kingdom
🇬🇧Imperial College Healthcare NHS Trust, London, United Kingdom
🇬🇧Chelsea & Westminster Hospital NHS Foundation Trust, London, United Kingdom
Drug Development Updates
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