Dolutegravir (Tivicay)

Other Names: DTG

All Clinical Trials

All Clinical Trials
Clinical Studies
- Treatment-Naive
- Treatment-Experienced
- Switch/Simplification
- Dual Therapy
- Monotherapy
- PREP
- PEP
- Acute HIV
Resistance/Virological Failure
Pharmacology
- General Pharmacology
- Adverse Effects
- Drug Interactions
Pregnancy/Women
Pediatrics
Review

DAWNING Industry

Official Title A Phase 3b, Randomized, Open-label Study of the Antiviral Activity and Safety of Dolutegravir Compared to Lopinavir/Ritonavir Both Administered With Dual Nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1 Infected Adult Subjects With Treatment Failure on First Line Therapy

Phase Phase IIIB

ClinicalTrials.gov NCT02227238

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Categories Resistance/Virological FailureTreatment-Experienced

Funding

IndustryViiV Healthcare

References

Aboud M, Kaplan R, Lombaard J, et al. Dolutegravir versus ritonavir-boosted lopinavir both with dual nucleoside reverse transcriptase inhibitor therapy in adults with HIV-1 infection in whom first-line therapy has failed (DAWNING): an open-label, non-inferiority, phase 3b trial. Lancet Infect Dis. 2019;19:253-64.
[PubMed Abstract]

DOMONO Non-Industry

Official Title The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial

Phase Phase IV

ClinicalTrials.gov NCT02401828

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Categories Treatment-ExperiencedSwitch/SimplificationMonotherapy

Funding

Non-IndustryErasmus Medical Center

References

Wijting I, Rokx C, Boucher C, et al. Dolutegravir as maintenance monotherapy for HIV (DOMONO): a phase 2, randomised non-inferiority trial. Lancet HIV. 2017;4:e547-e554.
[PubMed Abstract]

DUALIS Non-Industry Industry

Official Title Efficacy and Safety of Switching to Dolutegravir With Boosted Darunavir in Virologically Suppressed Adults With HIV-1: A Randomized, Open-Label, Multicenter, Phase 3, Noninferiority Trial: The DUALIS Study

Phase Phase III

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Categories Treatment-ExperiencedSwitch/SimplificationDual Therapy

Funding

IndustryJanssen Pharmaceuticals and ViiV Healthcare

Non-IndustryTechnical University Munich

References

Spinner CD, Kümmerle T, Schneider J, et al. Efficacy and Safety of Switching to Dolutegravir With Boosted Darunavir in Virologically Suppressed Adults With HIV-1: A Randomized, Open-Label, Multicenter, Phase 3, Noninferiority Trial: The DUALIS Study. Open Forum Infect Dis. 2020;7(9):ofaa356.
[PubMed Abstract]

FLAMINGO Industry

Official Title A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir, DTG (GSK1349572) 50 mg Once Daily Compared to Darunavir/Ritonavir (DRV/r) 800 mg/100 mg Once Daily Each Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral naïve Adult Subjects

Phase Phase IIIB

ClinicalTrials.gov NCT01449929

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Categories Treatment-Naive

Funding

IndustryViiV Healthcare and Shionogi & Co.

References

Clotet B, Feinberg J, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 2014;383:2222-31.
[PubMed Abstract]
Molina JM, Clotet B, van Lunzen J, et al. Once-daily dolutegravir is superior to once-daily darunavir/ritonavir in treatment-naïve HIV-1-positive individuals: 96 week results from FLAMINGO. J Int AIDS Soc. 2014;17:19490.
[PubMed Abstract]
Molina JM, Clotet B, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b study. Lancet HIV. 2015;2:e127-36.
[PubMed Abstract]

GS-380-1489 Industry

Official Title Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Phase Phase III

ClinicalTrials.gov NCT02607930

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Dolutegravir-Abacavir-Lamivudine

Tradename:TriumeqOther Names:DTG-ABC-3TCClass:Single-Tablet Regimens

Bictegravir-Tenofovir alafenamide-Emtricitabine

Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet Regimens

Categories Treatment-Naive

Funding

IndustryGilead Sciences

References

Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017;390:2063-72.
[PubMed Abstract]
Wohl DA, Yazdanpanah Y, Baumgarten A, et al. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6:e355-e363.
[PubMed Abstract]

GS-380-1490 Industry

Official Title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Phase Phase III

ClinicalTrials.gov NCT02607956

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Bictegravir-Tenofovir alafenamide-Emtricitabine

Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet Regimens

Categories Treatment-Naive

Funding

IndustryGilead Sciences

References

Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017;390:2073-82.
[PubMed Abstract]

NADIA Industry

Official Title Nucleosides And Darunavir/Dolutegravir In Africa (NADIA): a Randomised Controlled Trial of Darunavir Versus Dolutegravir and Tenofovir Versus Zidovudine in Second-line Antiretroviral Therapy Regimens for the Public Health Approach in Sub-Saharan Africa

Phase Phase III

ClinicalTrials.gov NCT03988452

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Funding

IndustryJanssen

References

Paton NI, Musaazi J, Kityo C, et al. Dolutegravir or Darunavir in Combination with Zidovudine or Tenofovir to Treat HIV. N Engl J Med. 2021;385:330-41.
[PubMed Abstract]
Paton NI, Musaazi J, Kityo C, et al. Efficacy and safety of dolutegravir or darunavir in combination with lamivudine plus either zidovudine or tenofovir for second-line treatment of HIV infection (NADIA): week 96 results from a prospective, multicentre, open-label, factorial, randomised, non-inferiority trial. Lancet HIV. 2022;9:e381-e393.
[PubMed Abstract]

NEAT 022 Non-Industry

Official Title Cardiovascular Risk in HIV Patients Switching From a Boosted Protease Inhibitor (PI) to Dolutegravir (DTG)

Phase Phase IV

ClinicalTrials.gov NCT02098837

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Categories PharmacologySwitch/SimplificationAdverse Effects

Funding

Non-IndustrySt Stephens Aids Trust

References

Gatell JM, Assoumou L, Moyle G, et al. Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk. AIDS. 2017;31:2503-14.
[PubMed Abstract]

SAILING Industry

Official Title A Randomized, Double-blind Study of the Safety and Efficacy of Dolutegravir (GSK1349572) 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults

Phase Phase III

ClinicalTrials.gov NCT01231516

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Raltegravir

Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)

Categories Resistance/Virological FailureTreatment-Experienced

Funding

IndustryViiV Healthcare

References

Cahn P, Pozniak AL, Mingrone H, et al. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013;382:700-8.
[PubMed Abstract]

SPRING-2 Industry

Official Title A Randomized, Double Blind Study of the Safety and Efficacy of Dolutegravir (GSK1349572) 50mg Once Daily to Raltegravir 400mg Twice Daily Both Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

Phase Phase III

ClinicalTrials.gov NCT01227824

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Raltegravir

Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)

Categories Treatment-Naive

Funding

IndustryViiV Healthcare

References

Raffi F, Jaeger H, Quiros-Roldan E, et al. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013;13:927-35.
[PubMed Abstract]
Raffi F, Rachlis A, Brinson C, et al. Dolutegravir efficacy at 48 weeks in key subgroups of treatment-naive HIV-infected individuals in three randomized trials. AIDS. 2015;29:167-74.
[PubMed Abstract]
Raffi F, Rachlis A, Stellbrink HJ, et al. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013;381:735-43.
[PubMed Abstract]

VIKING Industry

Official Title A Pilot Study to Assess the Antiviral Activity of Dolutegravir (GSK1349572) Containing Regimen in Antiretroviral Therapy (ART)-Experienced, HIV-1-infected Adult Subjects With Raltegravir Resistance

Phase Phase II

ClinicalTrials.gov NCT00950859

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Categories Resistance/Virological FailureTreatment-Experienced

Funding

IndustryViiV Healthcare

References

Eron JJ, Clotet B, Durant J, et al. Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study. J Infect Dis. 2013;207:740-8.
[PubMed Abstract]

VIKING-3 Industry

Official Title A Phase III Study to Demonstrate the Antiviral Activity and Safety of Dolutegravir in HIV-1 Infected Adult Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

Phase Phase III

ClinicalTrials.gov NCT01328041

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Categories Resistance/Virological FailureTreatment-Experienced

Funding

IndustryViiV Healthcare

References

Castagna A, Maggiolo F, Penco G, et al. Dolutegravir in antiretroviral-experienced patients with raltegravir- and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study. J Infect Dis. 2014;210:354-62.
[PubMed Abstract]

VIKING-4 Industry

Official Title A Phase III Randomized, Double-blind Trial Investigating the Activity of Dolutegravir 50 mg BID vs Placebo Over 7 Days in HIV-1-infected Subjects With RAL/ELV Resistance, Followed by an Open-label Phase With an Optimized Background Regimen

Phase Phase III

ClinicalTrials.gov NCT01568892

Treatments

Dolutegravir

Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)

Categories Resistance/Virological FailureTreatment-Experienced

Funding

IndustryViiV Healthcare

References

Akil B, Blick G, Hagins DP, et al. Dolutegravir versus placebo in subjects harbouring HIV-1 with integrase inhibitor resistance associated substitutions: 48-week results from VIKING-4, a randomized study. Antivir Ther. 2015;20:343-8.
[PubMed Abstract]