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Dolutegravir Sodium

FDA-approved product (tablet, oral), marketed as Tivicay, Tivicay Pd.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
4 of 4

Chemical structure

Chemical structure of Dolutegravir Sodium
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • HIV infection
  • HIV-1 infection

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Integrase inhibitors
Anti-infective classification
Classified as another kind of anti-infective (for example an antifungal, antiviral or antiparasitic medicine).WHO ATC J05AJ03

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis, MRSA, E. coli and K. pneumoniae. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA61.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli55.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae47.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis64.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-9.9 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-8.8 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-10.3 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-9.5 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Dolutegravir Sodium with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Effect on HIV Medications on EPC Cells

    NCT03782142 · start 2018-11-01

    Registered record
    Registry ID
    NCT03782142
    Conditions
    AIDS
    Interventions
    Tenofovir; Rilpivirine; Prezcobix; Dolutegravir
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2018-11-01
    Completion
    2021-12-14
    Enrolment
    22

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAIDS
    InterventionTenofovir; Rilpivirine; Prezcobix; Dolutegravir
    PhaseNot recorded
    Registry statusCompleted
  • Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study

    NCT03639311 · start 2018-09-24

    Registered record
    Registry ID
    NCT03639311
    Conditions
    HIV Infections
    Interventions
    CAB LA; RPV LA; RPV; DTG
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2018-09-24
    Completion
    2023-01-30
    Enrolment
    97

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHIV Infections
    InterventionCAB LA; RPV LA; RPV; DTG
    PhasePhase 2
    Registry statusCompleted
  • Bioavailability Study of 10 Milligram (mg) and 5 mg Tablets Versus Conventional Tablets of Dolutegravir

    NCT03095638 · start 2017-05-03

    Registered record
    Registry ID
    NCT03095638
    Conditions
    HIV Infections
    Interventions
    Conventional dolutegravir 10 mg tablet; Conventional dolutegravir 50 mg tablet; Dispersible dolutegravir 5 mg tablet; Conventional dolutegravir 25 mg tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2017-05-03
    Completion
    2017-06-23
    Enrolment
    38

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHIV Infections
    InterventionConventional dolutegravir 10 mg tablet; Conventional dolutegravir 50 mg tablet; Dispersible dolutegravir 5 mg tablet; Conventional dolutegravir 25 mg tablet
    PhasePhase 1
    Registry statusCompleted
  • National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection

    NCT02987530 · start 2017-04-11

    Registered record
    Registry ID
    NCT02987530
    Conditions
    HIV-1 Infection
    Interventions
    Dolutegravir; Darunavir-cobicistat; Emtricitabine-Tenofovir
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-04-11
    Completion
    2020-01-31
    Enrolment
    101

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHIV-1 Infection
    InterventionDolutegravir; Darunavir-cobicistat; Emtricitabine-Tenofovir
    PhasePhase 3
    Registry statusCompleted
  • Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study

    NCT02245022 · start 2017-03-14

    Registered record
    Registry ID
    NCT02245022
    Conditions
    HIV; Pregnancy
    Interventions
    Dolutegravir 50mg od; Standard of Care
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Completed
    Start
    2017-03-14
    Completion
    2018-12-06
    Enrolment
    60

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHIV; Pregnancy
    InterventionDolutegravir 50mg od; Standard of Care
    PhasePhase 2 / Phase 3
    Registry statusCompleted
  • ADVANCE Study of DTG + TAF + FTC vs DTG + TDF + FTC and EFV + TDF+FTC in First-line Antiretroviral Therapy

    NCT03122262 · start 2017-01-16

    Registered record
    Registry ID
    NCT03122262
    Conditions
    HIV-1 Infection
    Interventions
    Dolutegravir; Tenofovir Alafenamide; Truvada; Atripla
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-01-16
    Completion
    2022-07-29
    Enrolment
    1,110

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHIV-1 Infection
    InterventionDolutegravir; Tenofovir Alafenamide; Truvada; Atripla
    PhasePhase 3
    Registry statusCompleted
  • Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis

    NCT02583048 · start 2016-08-15

    Registered record
    Registry ID
    NCT02583048
    Conditions
    Tuberculosis; HIV Infections
    Interventions
    Bedaquiline; Delamanid; Dolutegravir; Multidrug Background Treatment (MBT) for TB
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2016-08-15
    Completion
    2021-02-04
    Enrolment
    84

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionTuberculosis; HIV Infections
    InterventionBedaquiline; Delamanid; Dolutegravir; Multidrug Background Treatment (MBT) for TB
    PhasePhase 2
    Registry statusCompleted
  • Relative Bio-availability Study of Dolutegravir and Lamivudine Fixed Dose Combinations

    NCT02738931 · start 2016-05

    Registered record
    Registry ID
    NCT02738931
    Conditions
    Infection, Human Immunodeficiency Virus
    Interventions
    Dolutegravir 50 mg tablet; Lamivudine 300 mg tablet; Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA); Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2016-05
    Completion
    2016-06
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfection, Human Immunodeficiency Virus
    InterventionDolutegravir 50 mg tablet; Lamivudine 300 mg tablet; Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA); Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)
    PhasePhase 1
    Registry statusCompleted
  • Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection

    NCT02656511 · start 2015-12

    Registered record
    Registry ID
    NCT02656511
    Conditions
    HIV
    Interventions
    Dolutegravir; Emtricitabine/Tenofovir
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Active not recruiting
    Start
    2015-12
    Completion
    2028-05
    Enrolment
    74

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHIV
    InterventionDolutegravir; Emtricitabine/Tenofovir
    PhasePhase 4
    Registry statusActive not recruiting
  • Dolutegravir Impact on Residual Replication

    NCT02500446 · start 2015-09-28

    Registered record
    Registry ID
    NCT02500446
    Conditions
    HIV
    Interventions
    dolutegravir; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2015-09-28
    Completion
    2017-09-30
    Enrolment
    40

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHIV
    Interventiondolutegravir; Placebo
    PhasePhase 4
    Registry statusCompleted
  • Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir

    NCT02337322 · start 2015-03-31

    Registered record
    Registry ID
    NCT02337322
    Conditions
    Acquired Immune Deficiency Syndrome Virus
    Interventions
    Dolutegravir; Darunavir/r
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2015-03-31
    Completion
    2019-12
    Enrolment
    104

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcquired Immune Deficiency Syndrome Virus
    InterventionDolutegravir; Darunavir/r
    PhasePhase 4
    Registry statusUnknown
  • Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany

    NCT02342769 · start 2015-02-19

    Registered record
    Registry ID
    NCT02342769
    Conditions
    HIV Infections
    Interventions
    Dolutegravir/Abacavir/Lamivudin
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2015-02-19
    Completion
    2018-10-28
    Enrolment
    403

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHIV Infections
    InterventionDolutegravir/Abacavir/Lamivudin
    PhaseNot recorded
    Registry statusCompleted
  • Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients

    NCT02370979 · start 2015-02

    Registered record
    Registry ID
    NCT02370979
    Conditions
    HIV-1 Infection
    Interventions
    Blood samples
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2015-02
    Completion
    2017-07
    Enrolment
    202

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHIV-1 Infection
    InterventionBlood samples
    PhasePhase 4
    Registry statusUnknown
  • Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects

    NCT02373930 · start 2015-02

    Registered record
    Registry ID
    NCT02373930
    Conditions
    Infection, Human Immunodeficiency Virus
    Interventions
    DTG 50 mg; RPV 25 mg; DTG/RPV 50 mg/25 mg: Product Code AS; DTG/RPV 50 mg/25 mg: Product Code AM; DTG/RPV 50 mg/25 mg: Product Code AQ; DTG/RPV 50 mg/25 mg: Product Code AK; DTG/RPV 50 mg/25 mg: Product Code AR
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2015-02
    Completion
    2015-09
    Enrolment
    63

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionInfection, Human Immunodeficiency Virus
    InterventionDTG 50 mg; RPV 25 mg; DTG/RPV 50 mg/25 mg: Product Code AS; DTG/RPV 50 mg/25 mg: Product Code AM +3 more
    PhasePhase 1
    Registry statusCompleted
  • Multicentre Study To Assess Changes In Bone Mineral Density Of The Switch From Protease Inhibitors To Dolutegravir In HIV-1-Infected Subjects With Low Bone Mineral Density

    NCT01966822 · start 2014-01

    Registered record
    Registry ID
    NCT01966822
    Conditions
    HIV-1 Infection
    Interventions
    Dolutegravir, 50mg every 24 hours; Protease Inhibitor/ritonavir
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2014-01
    Completion
    2015-10
    Enrolment
    75

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHIV-1 Infection
    InterventionDolutegravir, 50mg every 24 hours; Protease Inhibitor/ritonavir
    PhasePhase 3
    Registry statusCompleted