Data updated: Sep 20, 2026
DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE (dolutegravir) · Lupin
Infectious Disease
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- ORAL
- Dosage Forms
- TABLET
DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE Approval History
No approval records found
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Clinical Trial Registry
51 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05652478 | 10000906 000906-I | Ph 2 | recruiting | Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study |
| NCT07532304 | 4646-006 MK-4646-006 | Ph 1 | completed | A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646) |
| NCT02987530 OPTIPRIM-2 | ANRS 169 OPTIPRIM-2 2016-001683-11 | Ph 3 | completed | National Multicenter Trial Evaluating Two Treatments in Patients With Primary Human Immunodeficiency Virus (HIV-1) Infection |
| NCT05630638 DoraDO | UoL001707 | Ph 4 | recruiting | Doravirine Dose Optimisation in Pregnancy |
| NCT07124559 | IMPAACT 2024 38747 | Ph 1, Ph 2 | not yet recruiting | A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV |
| NCT05122767 DOLPHIN KIDS | IRB00280272 | Ph 1, Ph 2 | active not recruiting | Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS) |
| NCT05979311 VOGUE | 219816 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy |
| NCT04771754 DTG Clamp results posted | CRF003 | Ph 1 | completed | The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers |
| NCT06805656 | SPARC-11 | Ph 2 | recruiting | Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals |
| NCT02259127 results posted | ODYSSEY (PENTA 20) 2014-002632-14 | Ph 2, Ph 3 | completed | ODYSSEY (PENTA 20) |
| NCT02656511 DGVTAF | IN-US-236-1354 | Ph 4 | active not recruiting | Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection |
| NCT03249181 DolPHIN-2 | DolPHIN-2 | Ph 3 | completed | Dolutegravir in Pregnant HIV Mothers and Their Neonates |
| NCT06281834 | 2024P000306 | Ph 1 | recruiting | Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention |
| NCT04166474 DoRIS | UoL001452 | Ph 4 | completed | Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin |
| NCT04493216 DOMINO results posted | 208379 | Ph 2 | terminated | A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults |
| NCT02437110 results posted | 150126 15-N-0126 | Ph 1 | completed | HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) |
| NCT04900038 DYNAMIC results posted | 212483 | Ph 2 | terminated | A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults |
| NCT04892654 DORDOL | CW004 2020-003928-17 | Ph 3 | recruiting | Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch |
| NCT03122262 ADVANCE | WRHI060 | Ph 3 | completed | ADVANCE Study of DTG + TAF + FTC vs DTG + TDF + FTC and EFV + TDF+FTC in First-line Antiretroviral Therapy |
| NCT02924389 results posted | IRB00089025 K23AI124913 | Ph 4 | terminated | Dolutegravir in Reservoirs |
| NCT03048422 VESTED results posted | IMPAACT 2010 30129 | Ph 3 | completed | Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants |
| NCT05236530 | CKAF156A2104 | Ph 1 | completed | Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir |
| NCT04229290 2SD | 2SD | Ph 4 | completed | Second-line Switch to Dolutegravir Study |
| NCT02583048 results posted | A5343 12005 | Ph 2 | completed | Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis |
| NCT03706898 | HIV-VM1500-07 | Ph 1 | completed | Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs |
| NCT04147715 results posted | 1908T0911 | Ph 1 | completed | Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults |
| NCT02499978 TMC114HIV2030 | deNUC | Ph 2, Ph 3 | withdrawn | Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity |
| NCT03813979 POLO | UMCN-AKF-16.03 | Ph 4 | withdrawn | Pharmacokinetics of Single-dose Dolutegravir in HIV-seronegative Subjects With Severe Hepatic Impairment Compared to Matched Controls. |
| NCT02566707 PRADAII | UMCN-AKF 14.08 | Ph 2 | terminated | Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen |
| NCT04183738 i2-D²EFT | 2019-10-i2-DEFT 18Q065 | Ph 4 | withdrawn | Inflammation and Co-Infections in D²EFT |
| NCT02401828 DOMONO | NL51858.078.14 | Ph 4 | completed | The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial |
| NCT02976259 DOLUPRIM | IMEA 051 | Ph 3 | completed | Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection |
| NCT02263326 ASPIRE results posted | ASPIRE | Ph 3 | completed | Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure |
| NCT03078556 results posted | 204994 | Ph 1 | completed | Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine |
| NCT02596334 MONCAY | CHRO 2015-03 | Ph 3 | terminated | Study to Evaluate the Efficacy of MONotherapy of TiviCAY® Versus a Triple Therapy in HIV-1-infected Patients |
| NCT02582684 results posted | ACTG A5353 2UM1AI068636 | Ph 2 | completed | Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients |
| NCT02098837 | NEAT 22/SSAT 060 | Ph 4 | completed | Cardiovascular Risk in HIV Patients Switching From a Boosted Protease Inhibitor (PI) to Dolutegravir (DTG) |
| NCT01263015 results posted | 114467 | Ph 3 | completed | A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial) |
| NCT02500446 DIORR | DIORR_20150306 | Ph 4 | completed | Dolutegravir Impact on Residual Replication |
| NCT02572947 MONODO | PRD-13-2015-I | Ph 2 | completed | A Pilot Study of MONOtherapy of DOlutegravir in HIV-1 Virologically Suppressed Patients |
| NCT02513147 | INDOOR | Ph 4 | completed | HIV Reservoir Dynamics After Switching to Dolutegravir in Patients on a PI and 2 NRTI Based Regimen |
| NCT02715479 | 206222 AI468-052 | Ph 1 | completed | A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176 |
| NCT01328041 VIKING-3 results posted | 112574 | Ph 3 | completed | A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen. |
| NCT02487706 | DTG_HD | Ph 4 | completed | Assessment of Dolutegravir Removed by Hemodialysis in HIV-infected Patients With End-stage Renal Disease |
| NCT01499199 results posted | 116070 | Ph 3 | completed | A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects |
| NCT01827540 | TBR 652-1-110 | Ph 1 | completed | Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam |
| NCT01459315 | 11-1733 | Ph 1 | completed | GSK1349572 Exposure in Blood, Seminal Fluid, and Rectal Fluid and Tissue in Healthy Male Subjects |
| NCT01467531 | 116181 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects |
| NCT01498861 | 111855 | Ph 1 | completed | Drug Interaction Study Between Dolutegravir and an Oral Contraceptive Containing Norgestimate and Ethinylestradiol |
| NCT01467518 | 115698 | Ph 1 | completed | Methadone-Dolutegravir (DTG - GSK1349572) Drug Interaction Study. |
Showing 50 of 51 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.