Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine Symtuza
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Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine Genvoya
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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
, Dolutegravir
Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)Lopinavir-Ritonavir
Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)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.
Official Title The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial
Phase Phase IV
ClinicalTrials.gov NCT02401828
Treatments
Dolutegravir
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.
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
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Dolutegravir
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.
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
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Dolutegravir
, Dolutegravir
Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)Ritonavir
Ritonavir
Tradename:NorvirOther Names:RTVClass:Pharmacokinetic EnhancersCategories 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.
- 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.
- 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.
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
, Dolutegravir
Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Bictegravir-Tenofovir alafenamide-Emtricitabine
Bictegravir-Tenofovir alafenamide-Emtricitabine
Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet RegimensCategories 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.
Common TitleNADIA 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
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.
- 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.
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
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.
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
, Dolutegravir
Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)Raltegravir
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.
Official Title A Randomized, Double-Blind Study of the Safety and Efficacy of Dolutegravir (GSK1349572) Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
Phase Phase III
ClinicalTrials.gov NCT01263015
Treatments
Dolutegravir
, Dolutegravir
Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)Efavirenz-Tenofovir DF-Emtricitabine
, Efavirenz-Tenofovir DF-Emtricitabine
Tradename:AtriplaOther Names:EFV-TDF-FTC, Efavirenz-Tenofovir disoproxil fumarate-EmtricitabineClass:Single-Tablet RegimensDolutegravir-Abacavir-Lamivudine
Dolutegravir-Abacavir-Lamivudine
Tradename:TriumeqOther Names:DTG-ABC-3TCClass:Single-Tablet RegimensCategories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryViiV Healthcare
References
- Tebas P, Kumar P, Hicks C, et al. Greater change in bone turnover markers for efavirenz/emtricitabine/tenofovir disoproxil fumarate versus dolutegravir + abacavir/lamivudine in antiretroviral therapy-naive adults over 144 weeks. AIDS. 2015;29:2459-64.
- Walmsley S, Baumgarten A, Berenguer J, et al. Brief Report: Dolutegravir Plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy-Naive Patients: Week 96 and Week 144 Results From the SINGLE Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2015;70:515-9.
- Walmsley SL, Antela A, Clumeck N, et al. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369:1807-18.
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
Abacavir-Lamivudine
, Abacavir-Lamivudine
Tradename:EpzicomOther Names:ABC-3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Dolutegravir
, Dolutegravir
Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)Raltegravir
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.
- 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.
- 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.
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
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.
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
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.
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
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.