Dolutegravir: all 173 studies that test it

Page 1 of 2. Open to participants first (18), then studies with results posted, then the rest; newest registration first within each.

• An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in AfricaNot yet recruitingNCT07792096Phase 3
• Dolutegravir/Lamivudine in Treatment-Naïve Pregnant WomenRecruitingNCT07616739Phase 4
• A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV TreatmentRecruitingNCT07393659Phase 3
• 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-UpRecruitingNCT07138144Phase 4
• Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral ExperienceRecruitingNCT07031063Phase 4
• Switch to Dolutegravir Plus Lamivudine Dual-Therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)RecruitingNCT06967753Phase 4
• Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in MexicoRecruitingNCT06907056Phase 4
• Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without AntiretroviralsRecruitingNCT06805656Phase 2
• Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults.Not yet recruitingNCT06787976Phase 4
• 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 recruitingNCT06580873Phase 4
• Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB TreatmentRecruitingNCT06497465Phase 3
• Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB PreventionRecruitingNCT06281834Phase 1
• Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in PediatricsRecruitingNCT05674656Phase 1/2
• Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized StudyRecruitingNCT05652478Phase 2
• Pharmacokinetics and Safety of DolutegravIr in NeonateRecruitingNCT05590325Phase 1/2
• Efficacy and Tolerability of DTG Plus 3TC in HIV Infected Adults With Virologically Suppression and TDF ToxicityNot yet recruitingNCT05493969Phase 4
• Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TBRecruitingNCT04746547Phase 4
• Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV RemissionRecruitingNCT02140255Phase 1/2
• A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAFCompletedNCT05911360Phase 3Results posted
• Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated TuberculosisCompletedNCT05630872Phase 2Results posted
• A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1CompletedNCT05406583Phase 1Results posted
• Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to LamivudineCompletedNCT04880785Phase 2Results posted
• Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3CompletedNCT04880395Phase 4Results posted
• A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy ParticipantsCompletedNCT04857892Phase 1Results posted
• A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult ParticipantsCompletedNCT04827134Phase 1Results posted
• The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy VolunteersCompletedNCT04771754Phase 1Results posted
• Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAFCompletedNCT04585737Phase 4Results posted
• Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected IndividualsTerminatedNCT04272242Phase 2Results posted
• Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)CompletedNCT04021290Phase 3Results posted
• Tenofovir-lamivudine-dolutegravir Combination as Second-line ART: a Randomised Controlled TrialCompletedNCT03991013Phase 2Results posted
• Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected AdultsCompletedNCT03945981Phase 3Results posted
• Dolutegravir Pediatric Liquid Formulation StudyCompletedNCT03921723Phase 1Results posted
• Standard Versus Double Dose Dolutegravir in Patients With HIV-associated TuberculosisCompletedNCT03851588Phase 2Results posted
• Study to Evaluate the Pharmacokinetic (PK) Interactions Between GSK3640254 and Dolutegravir (DTG)CompletedNCT03816696Phase 1Results posted
• Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected AdolescentsCompletedNCT03682848Phase 3Results posted
• Rapid HIV Treatment Initiation, Access and Engagement in CareCompletedNCT03512964Not applicableResults posted
• Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)CompletedNCT03446573Phase 3Results posted
• Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant PatientsCompletedNCT03360682Phase 4Results posted
• ENLIGHTEN: Establishing Novel Antiretroviral (ARV) Imaging for Hair to Elucidate Non-AdherenceCompletedNCT03218592Phase 4Results posted
• Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and LamivudineCompletedNCT03078556Phase 1Results posted
• Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their InfantsCompletedNCT03048422Phase 3Results posted
• Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019CompletedNCT03016533Phase 3Results posted
• Dolutegravir in ReservoirsTerminatedNCT02924389Phase 4Results posted
• Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 PatientsCompletedNCT02582684Phase 2Results posted
• Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)CompletedNCT02519777Phase 4Results posted
• HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)CompletedNCT02437110Phase 1Results posted
• Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1)CompletedNCT02429791Phase 3Results posted
• Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)CompletedNCT02422797Phase 3Results posted
• Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative VolunteersCompletedNCT02404805Not applicableResults posted
• Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV InfectionCompletedNCT02384395Not applicableResults posted
• Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug ExposureCompletedNCT02263326Phase 3Results posted
• ODYSSEY (PENTA 20)CompletedNCT02259127Phase 2/3Results posted
• Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot StudyCompletedNCT02245022Phase 2/3Results posted
• Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line TreatmentCompletedNCT02227238Phase 3Results posted
• Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infectionCompletedNCT02178592Phase 3Results posted
• ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus InfectionCompletedNCT02075593Phase 3Results posted
• A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)CompletedNCT01910402Phase 3Results posted
• Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS PatientsCompletedNCT01837277Phase 2/3Results posted
• Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or ElivitegravirCompletedNCT01568892Phase 3Results posted
• A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive SubjectsCompletedNCT01499199Phase 3Results posted
• Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive SubjectsCompletedNCT01449929Phase 3Results posted
• A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.CompletedNCT01328041Phase 3Results posted
• Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and AdolescentsCompletedNCT01302847Phase 1/2Results posted
• A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive AdultsCompletedNCT01231516Phase 3Results posted
• A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice DailyCompletedNCT01227824Phase 3Results posted
• A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive SubjectsCompletedNCT00951015Phase 2Results posted
• A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to RaltegravirCompletedNCT00950859Phase 2Results posted
• Phase IIa Dose-ranging Study of GSK1349572 in HIV-1 Infected AdultsCompletedNCT00708110Phase 2Results posted
• A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)CompletedNCT07532304Phase 1
• A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Dolutegravir Sodium Tablets (DTG)CompletedNCT07002229Phase 1
• Bioequivalence Study to Compare Dolutegravir 50mg Film-coated TabletsCompletedNCT06450275Phase 1
• B/F/TAF to DTG/3TC Switch StudyActive, not recruitingNCT06444620Phase 3
• Assess the Effectiveness and Safety of Lipovirtide Combined With Nucleoside Drugs in HIV-infected Patients.CompletedNCT06061536Phase 2
• UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for ChildrenCompletedNCT05993767Phase 2
• 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 recruitingNCT05979311Phase 3
• A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral TherapyCompletedNCT05917509Phase 3
• Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral LoadCompletedNCT05898841Phase 4
• Effect of Dolutegravir Intensification on HIV-1 ReservoirsCompletedNCT05351684Phase 2
• Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot StudyWithdrawnNCT05295394Phase 4
• Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and DolutegravirCompletedNCT05236530Phase 1
• Triumeq in Amyotrophic Lateral SclerosisTerminatedNCT05193994Phase 3
• Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)Active, not recruitingNCT05122767Phase 1/2
• Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg)CompletedNCT05030025Early Phase 1
• Early DOlutegravir/LAmivudine Switching After Virological Suppression (EDOLAS Study)Status unknownNCT04979468Phase 3
• Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIVActive, not recruitingNCT04910711Phase 4
• Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected IndividualsCompletedNCT04904406Phase 4
• Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir DisproxilStatus unknownNCT04903847Phase 4
• Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)Active, not recruitingNCT04826562Phase 4
• Contribution of Dolutegravir to Obesity and Cardiovascular DiseaseCompletedNCT04340388Phase 4
• DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years OldActive, not recruitingNCT04337450Phase 2/3
• Second-line Switch to Dolutegravir StudyCompletedNCT04229290Phase 4
• Implication for Strategies of Long Term Control of Viral Replication in Patient With Primary HIV Infection (PHI).Status unknownNCT04225325Phase 4
• Inflammation and Co-Infections in D²EFTWithdrawnNCT04183738Phase 4
• Drug Interactions Between Dolutegravir and Escalating Doses of RifampicinCompletedNCT04166474Phase 4
• ANRS 12372 MODERATO StudyCompletedNCT04022967Phase 3
• Nucleosides And Darunavir/Dolutegravir In AfricaStatus unknownNCT03988452Phase 3
• Pharmacokinetics of Single-dose Dolutegravir in HIV-seronegative Subjects With Severe Hepatic Impairment Compared to Matched Controls.WithdrawnNCT03813979Phase 4
• Efficacy, Safety and Pharmacokinetics of DTG With RIFCompletedNCT03731559Phase 2
• Body Composition Sub-study of the D2EFT TrialCompletedNCT03675815Phase 4
• Effect of Reducing Nucleotide Exposure on Bone Health (ReNew)WithdrawnNCT03549689Phase 2

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