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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.

  • Study of GS-3242 in Participants With HIV-1; Substudy-05

    NCT07001319 · start 2025-05-29

    Registered record
    Registry ID
    NCT07001319
    Conditions
    HIV-1-infection
    Interventions
    GS-3242; BVY; Standard of Care
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2025-05-29
    Completion
    2026-04-16
    Enrolment
    27

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

    ConditionHIV-1-infection
    InterventionGS-3242; BVY; Standard of Care
    PhasePhase 1
    Registry statusCompleted
  • Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses

    NCT06338826 · start 2025-02-01

    Registered record
    Registry ID
    NCT06338826
    Conditions
    HIV Infections; HBV Coinfection
    Interventions
    TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI; Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2025-02-01
    Completion
    2027-09-30
    Enrolment
    140

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

    ConditionHIV Infections; HBV Coinfection
    InterventionTDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI; Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)
    PhasePhase 2
    Registry statusNot yet recruiting
  • Efficacy and Safety of DTG/3TC in Treatment-naïve HIV-1 Infected Patients

    NCT06928090 · start 2025-01-24

    Registered record
    Registry ID
    NCT06928090
    Conditions
    HIV
    Interventions
    DTG + 3TC FDC
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Enrolling by invitation
    Start
    2025-01-24
    Completion
    2027-01-30
    Enrolment
    200

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

    ConditionHIV
    InterventionDTG + 3TC FDC
    PhaseNot recorded
    Registry statusEnrolling by invitation
  • UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children

    NCT05993767 · start 2024-12-11

    Registered record
    Registry ID
    NCT05993767
    Conditions
    HIV Infection
    Interventions
    dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen; Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2024-12-11
    Completion
    2026-01-20
    Enrolment
    53

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

    ConditionHIV Infection
    Interventiondolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen; Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF)
    PhasePhase 2
    Registry statusCompleted
  • Selection of Resistant Mutations to Dolutegravir in PLWH Treated in Mozambique

    NCT06607588 · start 2024-10-25

    Registered record
    Registry ID
    NCT06607588
    Conditions
    HIV; HIV Antiretroviral Therapy (ART) Adherence
    Interventions
    Not applicable- observational study
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2024-10-25
    Completion
    2026-09
    Enrolment
    200

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

    ConditionHIV; HIV Antiretroviral Therapy (ART) Adherence
    InterventionNot applicable- observational study
    PhaseNot recorded
    Registry statusRecruiting
  • LIROH - Liraglutide for Obesity in HIV

    NCT06438146 · start 2024-05-02

    Registered record
    Registry ID
    NCT06438146
    Conditions
    Obesity; HIV Infections
    Interventions
    Liraglutide
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2024-05-02
    Completion
    2025-05
    Enrolment
    40

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

    ConditionObesity; HIV Infections
    InterventionLiraglutide
    PhasePhase 4
    Registry statusUnknown
  • A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF

    NCT05911360 · start 2023-07-07

    Registered record
    Registry ID
    NCT05911360
    Conditions
    HIV; HIV Infections
    Interventions
    DTG/3TC
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2023-07-07
    Completion
    2026-02-09
    Enrolment
    205

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

    ConditionHIV; HIV Infections
    InterventionDTG/3TC
    PhasePhase 3
    Registry statusCompleted
  • Improving HIV-1 Control in Africa with Long Acting Antiretrovirals

    NCT05546242 · start 2022-12-08

    Registered record
    Registry ID
    NCT05546242
    Conditions
    HIV-1-infection
    Interventions
    Cabotegravir/Rilpivirine; Antiretroviral
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2022-12-08
    Completion
    2026-03
    Enrolment
    540

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

    ConditionHIV-1-infection
    InterventionCabotegravir/Rilpivirine; Antiretroviral
    PhasePhase 3
    Registry statusActive not recruiting
  • Study of Novel Antiretrovirals in Participants With HIV-1

    NCT05585307 · start 2022-10-26

    Registered record
    Registry ID
    NCT05585307
    Conditions
    HIV-1-infection
    Interventions
    Bavtavirine; B/F/TAF; Standard of Care (Substudy 01); GS-1720; Standard of Care (Substudy 02); GS-6212; Standard of Care (Substudy 03)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2022-10-26
    Completion
    2024-03-18
    Enrolment
    49

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

    ConditionHIV-1-infection
    InterventionBavtavirine; B/F/TAF; Standard of Care (Substudy 01); GS-1720 +3 more
    PhasePhase 1
    Registry statusCompleted
  • Pharmacokinetics and Safety of DolutegravIr in Neonate

    NCT05590325 · start 2022-09-12

    Registered record
    Registry ID
    NCT05590325
    Conditions
    Hiv
    Interventions
    Dolutegravir
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Unknown
    Start
    2022-09-12
    Completion
    2024-12-31
    Enrolment
    56

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

    ConditionHiv
    InterventionDolutegravir
    PhasePhase 1 / Phase 2
    Registry statusUnknown
  • Efficacy and Tolerability of DTG Plus 3TC in HIV Infected Adults With Virologically Suppression and TDF Toxicity

    NCT05493969 · start 2022-08

    Registered record
    Registry ID
    NCT05493969
    Conditions
    Acquired Immunodeficiency Syndrome
    Interventions
    Dolutegravir 50 MG plus lamivudine 300 MG; Dolutegravir/lamivudine (50 MG/300 MG)
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2022-08
    Completion
    2026-06
    Enrolment
    100

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

    ConditionAcquired Immunodeficiency Syndrome
    InterventionDolutegravir 50 MG plus lamivudine 300 MG; Dolutegravir/lamivudine (50 MG/300 MG)
    PhasePhase 4
    Registry statusUnknown
  • Tolerability of Lopinavir Versus Dolutegravir for Children and Adolescents Living With HIV

    NCT05426421 · start 2022-07-11

    Registered record
    Registry ID
    NCT05426421
    Conditions
    HIV
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2022-07-11
    Completion
    2023-09-20
    Enrolment
    258

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

    ConditionHIV
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted
  • Obesogenic Origins of Maternal and Child Metabolic Health Involving Dolutegravir

    NCT04991402 · start 2021-09-21

    Registered record
    Registry ID
    NCT04991402
    Conditions
    HIV; Obesity; Obesity, Infant; Maternal Obesity During Childbirth; Maternal Obesity Complicating Pregnancy
    Interventions
    Dolutegravir-based antiretroviral therapy
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2021-09-21
    Completion
    2025-05-30
    Enrolment
    1,920

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

    ConditionHIV; Obesity; Obesity, Infant; Maternal Obesity During Childbirth +1 more
    InterventionDolutegravir-based antiretroviral therapy
    PhaseNot recorded
    Registry statusCompleted
  • Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment

    NCT05883761 · start 2021-09-07

    Registered record
    Registry ID
    NCT05883761
    Conditions
    Neural Tube Defects; Congenital Abnormalities; Teratogens
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2021-09-07
    Completion
    2023-09-30
    Enrolment
    50,075

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

    ConditionNeural Tube Defects; Congenital Abnormalities; Teratogens
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted
  • Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

    NCT04518228 · start 2021-09-01

    Registered record
    Registry ID
    NCT04518228
    Conditions
    HIV; Tuberculosis
    Interventions
    Bictegravir (BIC); Tenofovir alafenamide (TAF); Long-acting injectable formulation of cabotegravir (CAB LA); Dolutegravir (DTG); Atazanavir/ritonavir (ATV/r); Darunavir/ritonavir (DRV/r); Lopinavir/ritonavir (LPV/r); Cobicistat; Ritonavir; First-Line TB Treatment; Second-Line TB Treatment; Doravirine (DOR)
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Terminated
    Start
    2021-09-01
    Completion
    2025-07-10
    Enrolment
    205

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

    ConditionHIV; Tuberculosis
    InterventionBictegravir (BIC); Tenofovir alafenamide (TAF); Long-acting injectable formulation of cabotegravir (CAB LA); Dolutegravir (DTG) +8 more
    PhaseNot recorded
    Registry statusTerminated