Drug
Dolutegravir clinical trials
Also written GSK1349572, Tivicay and DTG.
- studies test it
- 173
- open now
- 18
- in phase 3
- 44
- first study started
- 2007
Keep track of what changes. Save the Dolutegravir studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Studies by the year they started
173 studies that test it; most in 2015 (18)
| Year | Studies |
|---|---|
| 2007 | 1 |
| 2008 | 5 |
| 2009 | 7 |
| 2010 | 8 |
| 2011 | 14 |
| 2012 | 4 |
| 2013 | 3 |
| 2014 | 13 |
| 2015 | 18 |
| 2016 | 15 |
| 2017 | 13 |
| 2018 | 6 |
| 2019 | 14 |
| 2020 | 6 |
| 2021 | 14 |
| 2022 | 7 |
| 2023 | 7 |
| 2024 | 7 |
| 2025 | 5 |
| 2026 | 6 |
By phase
A phase 1/2 study counts in both.
- Early Phase 1
- 1
- Phase 1
- 58
- Phase 2
- 33
- Phase 3
- 44
- Phase 4
- 41
- No phase
- 6
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 72 · Other 101
ViiV Healthcare (57) · National Institute of Allergy and Infectious Diseases (NIAID) (8) · GlaxoSmithKline (8) · ANRS, Emerging Infectious Diseases (4) · University of North Carolina, Chapel Hill (4) · St Stephens Aids Trust (4) · PENTA Foundation (3) · University of Liverpool (3)
Often tested with
Tested in the same studies.
Lamivudine (34) · Dolutegravir Sodium/Lamivudine (8) · Darunavir (8) · Abacavir (8) · Emtricitabine (7) · Tenofovir (7) · Tenofovir alafenamide (7) · Ritonavir (6)
Studies
Open first, then newest update. How each study uses Dolutegravir is read from its arms, and is right about nine times in ten.
Testing it · 173
- Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized StudyRecruitingPhase 2National Institute of Allergy and Infectious Diseases (NIAID)NCT05652478Written as Dolutegravir (DTG) AND Tenofovir alafenamide (TAF)
- Dolutegravir/Lamivudine in Treatment-Naïve Pregnant WomenRecruitingPhase 4Fundación HuéspedNCT07616739Written as Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]
- Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB TreatmentRecruitingPhase 3Johns Hopkins UniversityNCT06497465Written as Dolutegravir 50mg Tab
- Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV RemissionRecruitingPhase 1/2National Institute of Allergy and Infectious Diseases (NIAID)NCT02140255Written as Dolutegravir (DTG)
- An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in AfricaNot yet recruitingPhase 3University College, LondonNCT07792096Written as Dolutegravir (DTG)
- Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without AntiretroviralsRecruitingPhase 2Federal University of São PauloNCT06805656Written as Dolutegravir
- A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV TreatmentRecruitingPhase 3ViiV HealthcareNCT07393659Written as Dolutegravir (DTG)/ Lamivudine (3TC)
- Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB PreventionRecruitingPhase 1Brigham and Women's HospitalNCT06281834Written as Dolutegravir
- Switch to Dolutegravir Plus Lamivudine Dual-Therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)RecruitingPhase 4UBATECNCT06967753Written as Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)
- Efficacy, Safety, and ToLerability of Switching to A Two-Drug Regimen With DTG/3TC Compared to Maintaining A Three-Drug REgimen With BIC/FTC/TAF or DTG/3TC/ABC in ViroLogically SupprEssed PeopLe Living With HIV After 24 and 48 Weeks of Follow-UpRecruitingPhase 4José Antonio Mata MarínNCT07138144Written as dual therapy
- Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults.Not yet recruitingPhase 4Instituto Mexicano del Seguro SocialNCT06787976Written as Dolutegravir (DTG)
- Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral ExperienceRecruitingPhase 4Instituto Mexicano del Seguro SocialNCT07031063Written as DTG/3TC
- Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in MexicoRecruitingPhase 4José Antonio Mata MarínNCT06907056Written as dual therapy
- Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in PediatricsRecruitingPhase 1/2ViiV HealthcareNCT05674656Written as Dolutegravir/Rilpivirine FDC
- Evaluation of Switch to Dolutegravir/Lamivudine (DTG/3TC) From Current Suppressive Antiretroviral Therapy in People Living With HIV (PLWH) Receiving Opioid Agonist Therapy (OAT)Not yet recruitingPhase 4Saskatchewan Health Authority - Regina AreaNCT06580873Written as DOVATO
- Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TBRecruitingPhase 4University of KwaZuluNCT04746547Written as Dolutegravir 50 MG
- Pharmacokinetics and Safety of DolutegravIr in NeonateRecruitingPhase 1/2Desmond Tutu TB CentreNCT05590325Written as Dolutegravir
- Efficacy and Tolerability of DTG Plus 3TC in HIV Infected Adults With Virologically Suppression and TDF ToxicityNot yet recruitingPhase 4Shanghai Public Health Clinical CenterNCT05493969Written as Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG)
- ANRS 12372 MODERATO StudyCompletedPhase 3ANRS, Emerging Infectious DiseasesNCT04022967Written as dolutegravir
- 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 TherapyActive, not recruitingPhase 3ViiV HealthcareNCT05979311Written as Dolutegravir
See all 173 studies that test Dolutegravir →
Given in every arm · 17 — Dolutegravir is usual care beside what is tested
- A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIVRecruitingPhase 1/2National Institute of Allergy and Infectious Diseases (NIAID)NCT07124559Written as Dolutegravir
- Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy SwitchRecruitingPhase 3Chelsea and Westminster NHS Foundation TrustNCT04892654Written as Dolutegravir
- BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)CompletedPhase 1/2Michael HoelscherNCT04044001Written as Dolutegravir 50mg Tab
- Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE StudyCompletedPhase 2ViiV HealthcareNCT03639311Written as DTG
- A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive AdultsTerminatedPhase 2ViiV HealthcareNCT04900038Written as Dolutegravir
- An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)CompletedPhase 3ViiV HealthcareNCT02831764Written as Dolutegravir (DTG)
- An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)CompletedPhase 3ViiV HealthcareNCT02831673Written as Dolutegravir (DTG)
- Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral DrugsCompletedEarly Phase 1Rhonda BrandNCT04302896Written as dolutegravir oral tablet 50mg
- Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary TuberculosisCompletedPhase 2National Institute of Allergy and Infectious Diseases (NIAID)NCT02583048Written as Dolutegravir
- 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 DrugsCompletedPhase 1ViriomNCT03706898Written as Dolutegravir
- Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy AdultsCompletedPhase 1ShionogiNCT04147715Written as Dolutegravir
- Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced AdultsTerminatedPhase 2ViiV HealthcareNCT02386098Written as Dolutegravir (DTG)
- A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)CompletedPhase 3ViiV HealthcareNCT01263015Written as Dolutegravir
- Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female VolunteersCompletedPhase 1ViiV HealthcareNCT01231542Written as GSK1349572
- A Study to Evaluate the Effect of Boceprevir and Telaprevir on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697).CompletedPhase 1ViiV HealthcareNCT01563328Written as DTG
- Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy SubjectsCompletedPhase 1ViiV HealthcareNCT02373930Written as DTG 50 mg
- A Study to Evaluate the Effects of Calcium Carbonate and Ferrous Fumarate on Pharmacokinetics of Dolutegravir in Healthy Adult SubjectsCompletedPhase 1ViiV HealthcareNCT01762995Written as Dolutegravir 50 mg
As the comparator · 16 — what is tested is compared with Dolutegravir
- A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)Not yet recruitingPhase 2ViiV HealthcareNCT07816250Written as DTG/3TC
- A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)RecruitingPhase 2ViiV HealthcareNCT07202546Written as Dolutegravir / Lamivudine (DTG/3TC)
- Efficacy and Safety of ACC017 Tablets Compared With Dolutegravir Sodium Tablets in Treatment-Naïve Adults With Human Immunodeficiency Virus Type 1 (HIV-1)RecruitingPhase 1/2Jiangsu Aidea Pharmaceutical Group Co., Ltd.NCT07711223Written as DTG+FTC/TAF
- Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 InfectionRecruitingPhase 2Carlos BritesNCT07555431Written as Dolutegravir (DTG)
- Doravirine Dose Optimisation in PregnancyRecruitingPhase 4University of LiverpoolNCT05630638Written as Dolutegravir
- Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH SuccessfullyRecruitingPhase 2Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaNCT06774872Written as Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab
- Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive ParticipantsActive, not recruitingPhase 3ViiV HealthcareNCT02938520Written as DTG Tablet
- Evaluating Inflammatory and Immunological Changes of HIV-positive Patients Switching to DTG Dual Regimen Compared to Those Switching to a Triple Drugs Regimen (B/F/TAF)CompletedPhase 4Cristina MussiniNCT04054089Written as dolutegravir 50 mg / lamivudine 300 mg
- Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected AdultsCompletedPhase 3Gilead SciencesNCT03547908Written as DTG
- A Phase IV Study to Assess the Impact of the Change of Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With HIV InfectionCompletedPhase 4Fundacion SEIMC-GESIDANCT04076423Written as Dual Therapy
- A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive AdultsTerminatedPhase 2ViiV HealthcareNCT04493216Written as Dolutegravir
- Switch From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to E/C/F/TAF in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE)TerminatedPhase 3IRCCS San RaffaeleNCT03493568Written as Dolutegravir 50 mg plus one RTI
- Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive AdultsCompletedPhase 3Gilead SciencesNCT02607956Written as DTG
- Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically SuppressedCompletedPhase 3Gilead SciencesNCT03110380Written as DTG
- Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive AdultsCompletedPhase 2Gilead SciencesNCT02397694Written as DTG
- Neurological Monitoring in Patients Switching From Dolutegravir Based Regimen to Bictegravir Based RegimenStatus unknownPhase 3Azienda Ospedaliera Universitaria SeneseNCT04155554Written as Dolutegravir/lamivudine/abacavir
Codes
What other systems call Dolutegravir · ClinicalTrials.gg INT006890
- MeSH (NLM) D000099226DolutegravirConfirmed NLM, Wikidata
- UNII (FDA) DKO1W9H7M1DOLUTEGRAVIRConfirmed FDA, NLM, Wikidata
- RxNorm 1433868Confirmed FDA, Wikidata
- Wikidata Q937224dolutegravirConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C121543DolutegravirOne source FDA
- DrugBank DB08930One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | D000099226 | Dolutegravir | Confirmed NLM, Wikidata |
| UNII (FDA) | DKO1W9H7M1 | DOLUTEGRAVIR | Confirmed FDA, NLM, Wikidata |
| RxNorm | 1433868 | — | Confirmed FDA, Wikidata |
| Wikidata | Q937224 | dolutegravir | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C121543 | Dolutegravir | One source FDA |
| DrugBank | DB08930 | — | One source Wikidata |
Also registered as dolutegravir sodium (UNII 1Q1V9V5WYQ · RxNorm 1433867), dolutegravir sodium monohydrate (UNII 0E1T06685X), dolutegravir, (4s,12ar)- (UNII S3BN9Q9EHW) and dolutegravir, (s,s)- (UNII FGD6SPP2VH).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.