Trial reportJournal of acquired immune deficiency syndromes (1999)2020
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.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 90 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
90 citing papers in PubMed, 2 syntheses or guidelines pooled it, 203 citations in OpenAlex.
- An international compendium of health state utilities in people with HIV: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Pooled it
- Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV - CDC Recommendations, United States, 2025.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2025Guideline
- VOGUE: Noninferior Efficacy of Dolutegravir/Lamivudine Versus Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-1 Naive to Treatment.Open forum infectious diseases · 2026Trial
- Longitudinal changes in plasma biomarkers of immune activation, neuronal inflammation and injury in persons with HIV initiating ART.HIV medicine · 2026Trial
- Three-Year CD4/CD8 Ratio Recovery After Initiation of Dual Versus Triple Integrase Inhibitor-Based Therapy in Naïve Adults With HIV.Open forum infectious diseases · 2026Trial
- D3/Penta 21 clinical trial design: A randomised non-inferiority trial with nested drug licensing substudy to assess dolutegravir and lamivudine fixed dose formulations for the maintenance of virological suppression in children with HIV-1 infection, aged 2 to 15 years.Contemporary clinical trials · 2024Trial
- Population pharmacokinetic modeling of dolutegravir/lamivudine to support a once-daily fixed-dose combination regimen in virologically suppressed adults living with HIV-1.Antimicrobial agents and chemotherapy · 2024Trial
- Trial
- Efficacy and Safety of Switching to Dolutegravir/Lamivudine Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Results Through Week 144 From the Phase 3, Noninferiority TANGO Randomized Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Integrase Inhibitor Resistance Mechanisms and Structural Characteristics in Antiretroviral Therapy-Experienced, Integrase Inhibitor-Naive Adults with HIV-1 Infection Treated with Dolutegravir plus Two Nucleoside Reverse Transcriptase Inhibitors in the DAWNING Study.Antimicrobial agents and chemotherapy · 2022Trial
- Virologic outcomes of switching to boosted darunavir plus dolutegravir with respect to history of drug resistance.AIDS research and therapy · 2021Trial
- 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.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020Trial
- Evaluation of Real-World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir/Lamivudine Fixed-Dose Combination in Treatment-Naive and Pretreated People Living With HIV Who are Virologically Suppressed, in Routine Clinical Care in France: Results From the CARAVEL Study.Open forum infectious diseases · 2026Article
- Renal and Cardiovascular Complications Following Type 2 Diabetes Mellitus in People With and Without HIV: Data From the Cohort Study on Morbidity and HIV in Sweden (COSMOHS) Between 2010 and 2024.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Temporal trends and clinical outcomes of antiretroviral therapy initiation and regimens in treatment-naive people with HIV: A real-world study at a tertiary specialist hospital in Beijing, China.Infectious diseases & immunity · 2026Article
- Beyond Surveillance Mutations: Long-Term Trends and Clinical Relevance of Transmitted HIV Drug Resistance in Spain (2007-2023).Open forum infectious diseases · 2026Article
- 'Leaving no stones unturned': up to 10 years results on the effectiveness, tolerability and metabolic safety of dolutegravir+lamivudine (DTG+3TC) as a switch regimen in the ODOACRE cohort.The Journal of antimicrobial chemotherapy · 2026Observational
- Use of dual ART in individuals with different HBV serological patterns.Current opinion in HIV and AIDS · 2026Review
- HIV-1 virologic failure in the RESINA cohort: lessons from two decades of real-world data.Infection · 2026Article
- Comparative effectiveness of dolutegravir + lamivudine versus three-drug regimens in Swedish clinical practice: a nationwide study.Journal of the International AIDS Society · 2026Article
30 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
21 authors at 10 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 2-drug regimen dolutegravir + lamivudine was noninferior to dolutegravir + tenofovir disoproxil fumarate/emtricitabine in achieving HIV-1 RNA <50 copies/mL in treatment-naive adults in the 48-week primary analysis of the GEMINI trials. We present results from the prespecified 96-week secondary analyses.
settingOne hundred eighty-seven centers in 21 countries.
methodsGEMINI-1 and GEMINI-2 are identical, double-blind phase III studies. Participants with screening HIV-1 RNA ≤500,000 copies/mL were randomized 1:1 to once-daily dolutegravir + lamivudine or dolutegravir + tenofovir disoproxil fumarate/emtricitabine.
resultsAt week 96, dolutegravir + lamivudine (N = 716) was noninferior to dolutegravir + tenofovir disoproxil fumarate/emtricitabine (N = 717) in achieving HIV-1 RNA <50 copies/mL (Snapshot algorithm; -10% noninferiority margin) in the pooled analysis (proportion of responders, 86.0% vs 89.5%, respectively; adjusted treatment difference [95% CI], -3.4% [-6.7 to 0.0007]), GEMINI-1 (-4.9% [-9.8 to 0.03]), and GEMINI-2 (-1.8% [-6.4 to 2.7]). Proportions of participants in the HIV-1 RNA ≥50 copies/mL Snapshot category were largely unchanged from week 48 to 96. Eleven participants taking dolutegravir + lamivudine and 7 taking dolutegravir + tenofovir disoproxil fumarate/emtricitabine met confirmed virologic withdrawal criteria through week 96; none had treatment-emergent resistance mutations. Dolutegravir + lamivudine had a lower rate of drug-related adverse events than dolutegravir + tenofovir disoproxil fumarate/emtricitabine (19.6% vs 25.0%; relative risk ratio, 0.78; 95% CI: 0.64 to 0.95). Renal and bone biomarker changes favored dolutegravir + lamivudine.
conclusionsConsistent with 48-week data, dolutegravir + lamivudine demonstrated long-term, noninferior efficacy vs dolutegravir + tenofovir disoproxil fumarate/emtricitabine without increased risk of treatment-emergent resistance, supporting its use in treatment-naive HIV-1-infected individuals.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.