Data updated: May 26, 2026
DOLUTEGRAVIR; RILPIVIRINE (dolutegravir)
Trial Activity: Declining 10 active trials
Infectious Disease
Development Insights
ViiV Healthcare conducting 12 trials (24%)
34 indications explored (Broad Platform)
→ hiv (11 trials)
→ infection, human immunodeficiency virus (6 trials)
→ hiv infections (5 trials)
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- ORAL
- Dosage Forms
- TABLET
DOLUTEGRAVIR; RILPIVIRINE 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 | recruiting | 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 | not yet recruiting | Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming 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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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; RILPIVIRINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment