Product
Dolutegravir
Aliases
Dolutegravir 50 mg, Dolutegravir 50 MG, Dolutegravir (DTG), Dolutegravir film-coated dispersible tablets (2 other aliases)
Name
Dolutegravir
INN Name
dolutegravir sodium
FDA Approved
Yes
34 clinical trials
2 organizations
26 indications
2 documents
Indication
HIV InfectionsIndication
HIVIndication
MalariaIndication
HIV-1 infectionIndication
Pregnancy RelatedIndication
TuberculosisIndication
Amyotrophic lateral sclerosisIndication
HIV-associated TuberculosisIndication
Healthy VolunteerIndication
Weight GainIndication
Metabolic EffectsIndication
Integrase Strand Transfer InhibitorsIndication
Pediatric HIV infectionIndication
HIV InfectionIndication
LTBIIndication
HIV infectionIndication
HIV-1 InfectionIndication
Adverse Reaction to Antiviral DrugsIndication
Vascular DiseasesIndication
Cardiovascular AbnormalitiesIndication
Adipose Tissue AbnormalityIndication
Body Weight ChangesIndication
Body Fat DisorderIndication
HIV-Associated Lipodystrophy SyndromeIndication
ContraceptionIndication
Antiretroviral TherapyClinical trial
A Phase IIb, Randomized, Double-blind, Parallel-group Study to Assess the Efficacy, Safety, Tolerability, and Resistance Profile of GSK3640254 in Combination With Dolutegravir Compared to Dolutegravir Plus Lamivudine in HIV-1 Infected, Treatment-naïve AdultsStatus: Terminated, Estimated PCD: 2022-11-22
Clinical trial
Open-label Access to Dolutegravir for HIV-1 Infected Children and Adolescents Completing IMPAACT Studies P1093 and P2019Status: Active (not recruiting), Estimated PCD: 2024-07-31
Clinical trial
A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofovir Alafenamide Once Daily for Virologic Suppression and Maintenance in Antiretroviral Therapy Naive Adults Living With HIVStatus: Not yet recruiting, Estimated PCD: 2025-09-22
Clinical trial
A Phase I, Open-label, Fixed-sequence, Two-period, Crossover, Drug-drug Interaction Study to Evaluate the Effect of Multiple Doses of Ganaplacide and Lumefantrine Combination on the Pharmacokinetics of Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir in Healthy ParticipantsStatus: Completed, Estimated PCD: 2022-10-17
Clinical trial
'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase InhibitorStatus: Completed, Estimated PCD: 2023-01-31
Clinical trial
A Phase IIb, Randomized, Partially Blind, Active Controlled, Dose-range Finding Study of GSK3640254 Compared to a Reference Arm of Dolutegravir, Each in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1 Infected Antiretroviral Treatment-naive AdultsStatus: Terminated, Estimated PCD: 2022-09-05
Clinical trial
Dolutegravir in Pregnant HIV Mothers and Their NeonatesStatus: Completed, Estimated PCD: 2020-10-20
Clinical trial
Drug Interactions Between Dolutegravir and Escalating Doses of RifampicinStatus: Active (not recruiting), Estimated PCD: 2024-01-01
Clinical trial
Impact of a Dolutegravir-based Regimen on Early Mortality of Severely Immunocompromised AIDS PatientsStatus: Completed, Estimated PCD: 2021-07-31
Clinical trial
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and PostpartumStatus: Recruiting, Estimated PCD: 2026-03-11
Clinical trial
HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)Status: Completed, Estimated PCD: 2022-11-17
Clinical trial
Gut Microbiota, Pharmacogenetics and Integrase Strand Transfer Inhibitors ResponseStatus: Completed, Estimated PCD: 2023-12-31
Clinical trial
An Open-label, Sequential Non-randomised Pharmacokinetics Study of DTG Plasma Exposure When Given as Twice or Once Daily DTG in the Presence of Rifampicin in Children With HIV and TB Between 20-35kgs in SAStatus: Recruiting, Estimated PCD: 2025-07-31
Clinical trial
Efficacy and Safety of Dolutegravir + Lamivudine in Antiretroviral Treatment-naive Adults With HIV-1 Infection in a Multicenter Real-life Cohort StudyStatus: Completed, Estimated PCD: 2021-06-15
Clinical trial
Safety, Tolerability and Drug-drug Interactions of Short-course Treatment of Latent Tuberculosis Infection With High-dose Once-weekly Rifapentine and Isoniazid (3HP) Among Infants, Children and Adolescents Living With HIV Taking Dolutegravir-based Antiretroviral TreatmentStatus: Recruiting, Estimated PCD: 2024-12-01
Clinical trial
Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated TuberculosisStatus: Recruiting, Estimated PCD: 2025-02-28
Clinical trial
Open Label, Randomized (1:1) Clinical Trial to Evaluate Switching From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE Study).Status: Terminated, Estimated PCD: 2018-03-20
Clinical trial
Doravirine Dose Optimisation in PregnancyStatus: Recruiting, Estimated PCD: 2025-11-01
Clinical trial
Open Label, Single Arm, Two-stage Trial to Evaluate the Single and Multi-dose Pharmacokinetics and Safety of the Paediatric Dolutegravir (10 mg, Scored) Dispersible Tablet in HIV-exposed NeonatesStatus: Recruiting, Estimated PCD: 2024-06-30
Clinical trial
Standard Versus Double Dose Dolutegravir in Patients With HIV-associated Tuberculosis: a Phase 2 Non-comparative Randomised Controlled TrialStatus: Completed, Estimated PCD: 2022-01-20
Clinical trial
Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch (DORDOL)Status: Recruiting, Estimated PCD: 2026-11-30
Clinical trial
A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy VolunteersStatus: Not yet recruiting, Estimated PCD: 2028-01-31
Clinical trial
The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy VolunteersStatus: Completed, Estimated PCD: 2023-12-31
Clinical trial
Body Composition Sub-study of the D2EFT TrialStatus: Active (not recruiting), Estimated PCD: 2024-01-15
Clinical trial
A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1Status: Recruiting, Estimated PCD: 2024-09-30
Clinical trial
Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Dolutegravir 50mg Film-coated Tablets (50mg Dolutegravir) Versus Tivicay 50mg Film-coated Tablets (50mg Dolutegravir) in Healthy Subjects Under Fasting ConditionsStatus: Completed, Estimated PCD: 2024-01-15
Clinical trial
Observational Assessment of the Nation-wide Roll-out of Dolutegravir in LesothoStatus: Completed, Estimated PCD: 2021-05-19
Clinical trial
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB PreventionStatus: Not yet recruiting, Estimated PCD: 2027-02-01
Clinical trial
Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected IndividualsStatus: , Estimated PCD: 2025-02-28
Clinical trial
Population Pharmacokinetics of Antiretroviral in ChildrenStatus: Completed, Estimated PCD: 2022-06-16
Clinical trial
WRHI 060 (ADVANCE): A Randomised, Phase 3 Non-inferiority Study of DTG + TAF + FTC Compared With DTG + TDF + FTC and EFV + TDF + FTC in Patients Infected With HIV-1 Starting First-line Antiretroviral Therapy - Extension to 192 WeeksStatus: Completed, Estimated PCD: 2022-04-30
Clinical trial
Contribution of the Integrase Inhibitor Dolutegravir to Obesity and Cardiovascular Disease in Persons Living With HIVStatus: Completed, Estimated PCD: 2022-06-17
Clinical trial
Contraceptives and Dolutegravir-based ARTStatus: Active (not recruiting), Estimated PCD: 2023-08-31
Clinical trial
Immediate Initiation of Antiretroviral Therapy During Acute HIV InfectionStatus: Active (not recruiting), Estimated PCD: 2027-05-01
Document
DailyMed Label: TivicayOrganization
RPK Pharmaceuticals, Inc.Document
DailyMed Label: DolutegravirOrganization
Mylan Laboratories Limited