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Common TitleACTG 5353 Non-Industry
Official Title Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients
Phase Phase II
ClinicalTrials.gov NCT02582684
Treatments
Lamivudine
, Lamivudine
Tradename:EpivirOther Names:3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Dolutegravir-Lamivudine
Dolutegravir-Lamivudine
Tradename:DovatoOther Names:DTG-3TCClass:Single-Tablet RegimensCategories Treatment-NaiveDual Therapy
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Nyaku AN, Zheng L, Gulick RM, et al. Dolutegravir plus lamivudine for initial treatment of HIV-1-infected participants with HIV-1 RNA <500 000 copies/mL: week 48 outcomes from ACTG 5353. J Antimicrob Chemother. 2019;74:1376-80.
- Taiwo BO, Zheng L, Stefanescu A, et al. ACTG A5353: A Pilot Study of Dolutegravir Plus Lamivudine for Initial Treatment of Human Immunodeficiency Virus-1 (HIV-1)-infected Participants With HIV-1 RNA <500000 Copies/mL. Clin Infect Dis. 2018;66:1689-97.
Official Title Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure (ASPIRE)
Phase Phase III
ClinicalTrials.gov NCT02263326
Treatments
Lamivudine
, Lamivudine
Tradename:EpivirOther Names:3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Dolutegravir-Lamivudine
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
Lamivudine
, Lamivudine
Tradename:EpivirOther Names:3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Dolutegravir-Lamivudine
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
Lamivudine
, Lamivudine
Tradename:EpivirOther Names:3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Dolutegravir-Lamivudine
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.
Common TitleLAMIDOL Non-Industry Industry
Official Title A Pilot Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple HAART - ANRS 167 Lamidol
Phase Phase II
ClinicalTrials.gov NCT02527096
Treatments
Lamivudine
, Lamivudine
Tradename:EpivirOther Names:3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Dolutegravir-Lamivudine
Dolutegravir-Lamivudine
Tradename:DovatoOther Names:DTG-3TCClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/SimplificationDual Therapy
Funding
IndustryViiV Healthcare
Non-IndustryFrench National Agency for Research on AIDS and Viral Hepatitis
References
- Joly V, Burdet C, Landman R, et al. Dolutegravir and lamivudine maintenance therapy in HIV-1 virologically suppressed patients: results of the ANRS 167 trial (LAMIDOL). J Antimicrob Chemother. 2019;74:739-45.
Common TitlePADDLE Non-Industry Industry
Official Title Dolutegravir-Lamivudine as Dual Therapy in Naive HIV-Infected Patients: A Pilot Study
Phase Phase IV
ClinicalTrials.gov NCT02211482
Treatments
Lamivudine
, Lamivudine
Tradename:EpivirOther Names:3TCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Dolutegravir-Lamivudine
Dolutegravir-Lamivudine
Tradename:DovatoOther Names:DTG-3TCClass:Single-Tablet RegimensCategories Treatment-NaiveDual Therapy
Funding
IndustryViiV Healthcare
Non-IndustryThe Huesped Foundation
References
- Cahn P, Rolón MJ, Figueroa MI, Gun A, Patterson P, Sued O. Dolutegravir-lamivudine as initial therapy in HIV-1 infected, ARV-naive patients, 48-week results of the PADDLE (Pilot Antiretroviral Design with Dolutegravir LamivudinE) study. J Int AIDS Soc. 2017;20:21678.
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
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
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.
Dolutegravir-Lamivudine Slide Deck
December 19, 2022
Clinical Trial Image Decks
ASPIRE - November 29, 2022
GEMINI-1 - November 29, 2022
GEMINI-2 - November 29, 2022
SALSA - December 31, 1969
TANGO - November 29, 2022