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Official Title A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women
Phase Phase IIIB
ClinicalTrials.gov NCT01910402
Treatments
Dolutegravir-Abacavir-Lamivudine
Dolutegravir-Abacavir-Lamivudine
Tradename:TriumeqOther Names:DTG-ABC-3TCClass:Single-Tablet RegimensCategories Pregnancy/WomenTreatment-Naive
Funding
IndustryViiV Healthcare
References
- Orrell C, Hagins DP, Belonosova E, et al. Fixed-dose combination dolutegravir, abacavir, and lamivudine versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate and emtricitabine in previously untreated women with HIV-1 infection (ARIA): week 48 results from a randomised, open-label, non-inferiority, phase 3b study. Lancet HIV. 2017;4:e536-e546.
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
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Dolutegravir-Abacavir-Lamivudine
, Dolutegravir-Abacavir-Lamivudine
Tradename:TriumeqOther Names:DTG-ABC-3TCClass:Single-Tablet RegimensBictegravir-Tenofovir alafenamide-Emtricitabine
Bictegravir-Tenofovir alafenamide-Emtricitabine
Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet RegimensCategories 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.
- 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.
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 Phase IIIb, Randomized, Open-label Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen Compared With Continuation of the Current Antiretroviral Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed, The STRIIVING Study.
Phase Phase IIIB
ClinicalTrials.gov NCT02105987
Treatments
Dolutegravir-Abacavir-Lamivudine
Dolutegravir-Abacavir-Lamivudine
Tradename:TriumeqOther Names:DTG-ABC-3TCClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryViiV Healthcare
References
- Trottier B, Lake JE, Logue K, et al. Dolutegravir/abacavir/lamivudine versus current ART in virally suppressed patients (STRIIVING): a 48-week, randomized, non-inferiority, open-label, Phase IIIb study. Antivir Ther. 2017;22:295-305.