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Official Title Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE)
Phase Phase III
ClinicalTrials.gov NCT02263326
Treatments
Dolutegravir-Lamivudine![Dolutegravir-Lamivudine Dovato](https://cdn.hiv.uw.edu/css/images/drugs/375.png)
![Dolutegravir-Lamivudine Dovato](https://cdn.hiv.uw.edu/css/images/drugs/375.png)
Dolutegravir-Lamivudine
Tradename:DovatoOther Names:DTG-3TCClass:Single-Tablet RegimensCategories Treatment-ExperiencedDual Therapy
Funding
IndustryViiV Healthcare
References
- Li JZ, Sax PE, Marconi VC, et al. No Significant Changes to Residual Viremia After Switch to Dolutegravir and Lamivudine in a Randomized Trial. Open Forum Infect Dis. 2019;6:ofz056.
- Taiwo BO, Marconi VC, Berzins B, et al. Dolutegravir Plus Lamivudine Maintains Human Immunodeficiency Virus-1 Suppression Through Week 48 in a Pilot Randomized Trial. Clin Infect Dis. 2018;66:1794-7.
Official Title An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (GEMINI 1)
Phase Phase III
ClinicalTrials.gov NCT02831673
Treatments
Dolutegravir-Lamivudine![Dolutegravir-Lamivudine Dovato](https://cdn.hiv.uw.edu/css/images/drugs/375.png)
![Dolutegravir-Lamivudine Dovato](https://cdn.hiv.uw.edu/css/images/drugs/375.png)
Dolutegravir-Lamivudine
Tradename:DovatoOther Names:DTG-3TCClass:Single-Tablet RegimensCategories Treatment-NaiveDual Therapy
Funding
IndustryViiV Healthcare
References
- Cahn P, Madero JS, Arribas JR, et al. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019;393:143-55.
- Cahn P, Madero JS, Arribas JR, et al. Durable Efficacy of Dolutegravir Plus Lamivudine in Antiretroviral Treatment-Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI-1 and GEMINI-2 Randomized Clinical Trials. J Acquir Immune Defic Syndr. 2020;83:310-18.
Official Title An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (GEMINI 2)
Phase Phase III
ClinicalTrials.gov NCT02831764
Treatments
Dolutegravir-Lamivudine![Dolutegravir-Lamivudine Dovato](https://cdn.hiv.uw.edu/css/images/drugs/375.png)
![Dolutegravir-Lamivudine Dovato](https://cdn.hiv.uw.edu/css/images/drugs/375.png)
Dolutegravir-Lamivudine
Tradename:DovatoOther Names:DTG-3TCClass:Single-Tablet RegimensCategories Treatment-NaiveDual Therapy
Funding
IndustryViiV Healthcare
References
- Cahn P, Madero JS, Arribas JR, et al. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019;393:143-55.
- Cahn P, Madero JS, Arribas JR, et al. Durable Efficacy of Dolutegravir Plus Lamivudine in Antiretroviral Treatment-Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI-1 and GEMINI-2 Randomized Clinical Trials. J Acquir Immune Defic Syndr. 2020;83:310-18.
Official Title A Phase III, Randomized, Multicenter, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine Fixed Dose Combination in HIV-1 Infected Adults Who Are Virologically Suppressed
Phase Phase III
ClinicalTrials.gov NCT04021290
Treatments
Dolutegravir-Lamivudine![Dolutegravir-Lamivudine Dovato](https://cdn.hiv.uw.edu/css/images/drugs/375.png)
![Dolutegravir-Lamivudine Dovato](https://cdn.hiv.uw.edu/css/images/drugs/375.png)
Dolutegravir-Lamivudine
Tradename:DovatoOther Names:DTG-3TCClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/SimplificationDual Therapy
Funding
IndustryViiV Healthcare
References
- Llibre JM, Brites C, Cheng CY, et al. Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With Human Immunodeficiency Virus 1 (HIV-1): Week 48 Results From the Phase 3, Noninferiority SALSA Randomized Trial. Clin Infect Dis. 2023;76:720-9.
Official Title A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed
Phase Phase III
ClinicalTrials.gov NCT03446573
Treatments
Dolutegravir-Lamivudine![Dolutegravir-Lamivudine Dovato](https://cdn.hiv.uw.edu/css/images/drugs/375.png)
![Dolutegravir-Lamivudine Dovato](https://cdn.hiv.uw.edu/css/images/drugs/375.png)
Dolutegravir-Lamivudine
Tradename:DovatoOther Names:DTG-3TCClass:Single-Tablet RegimensCategories Switch/SimplificationDual Therapy
Funding
IndustryViiV Healthcare
References
- van Wyk J, Ajana F, Bisshop F, et al. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020;71:1920-9.