Tivicay

(Dolutegravir)

ApprovedSmall molecule

Dolutegravir is used to treat HIV infection by helping to stop the virus from multiplying in the body, usually taken as part of a combination therapy with other HIV medications.[2] Tivicay is currently approved and in use across 15 indications[4].[1]

Tivicay is one of 330 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

158

Total Trials

Active Trials

329

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Viral DiseaseActive, not recruiting

Body Weight GainApproved

AIDSApproved

ContraceptionActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

HIVActive, not recruiting

Pediatric HIV InfectionRecruiting

HIV InfectionsCompleted

Antiretroviral TreatmentCompleted

EfficacyRecruiting

Viral DiseaseApproved

Active, not recruiting

Body Weight GainApproved

Approved

AIDSApproved

Approved

ContraceptionApproved

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

HIVApproved

Active, not recruiting

Pediatric HIV InfectionPhase 1

Recruiting

HIV InfectionsPhase 3

Completed

Antiretroviral TreatmentPhase 3

Completed

EfficacyPhase 3

Recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Tivicay

GSK

Approved

8 2

Dexilant

Takeda

Preclinical

2 3

Lamprene

Novartis

Preclinical

1 4

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 5

Emtriva

Gilead

Preclinical

1 6

Foscavir

CClinigen, Inc.

Preclinical

6 7

Valium

Akero Therapeutics

Preclinical

2 8

Sirturo

WWim Janssens

Preclinical

1 9

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 10

Reminyl

WWim Janssens

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2/3Active, not recruiting

HIV Infection

NCT04337450

Q4 2026

Active, not recruiting

HIV

NCT04707326

Q1 2027

Phase 3Active, not recruiting

HIV

NCT05979311

Q2 2027

Phase 1Recruiting

Pediatric HIV Infection

NCT06281834

Clinical

Trials by Indication[1]

Treatment8 trials

Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT02582684·122 enrolled

Rapid HIV Treatment Initiation, Access and Engagement in Care

Completed·JJohns Hopkins University·N/A·NCT03512964·32 enrolled

Real Life Study of Dolutegravir Plus Lamivudine in HIV-1-Infected Treatment-Naive Patients

Completed·UUniversity Hospital Virgen de las Nieves··NCT04002323·88 enrolled

Show 5 more trials

Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults.

Not yet recruiting·IInstituto Mexicano del Seguro Social·Phase 4·NCT06787976·140 enrolled

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)

Completed· GSK logo

GSK·Phase 3·NCT02831764·722 enrolled

Dolutegravir Plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects

Completed·BBlueclinical, Ltd.·Phase 2·NCT03224338·30 enrolled

An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1)

Completed· GSK logo

GSK·Phase 3·NCT02831673·719 enrolled

Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults

Terminated· GSK logo

GSK·Phase 2·NCT02386098·86 enrolled

Interaction7 trials

Drug Interaction Study Between Dolutegravir and an Oral Contraceptive Containing Norgestimate and Ethinylestradiol

Completed· GSK logo

GSK·Phase 1·NCT01498861·16 enrolled

Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers

Completed·UUniversity of Colorado, Denver·N/A·NCT02404805·25 enrolled

Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults

Completed· Shionogi logo

Shionogi·Phase 1·NCT04147715·98 enrolled

Show 4 more trials

Dolutegravir Interactions With Artemisinin-based Combination Therapies

Completed·UUniversity of Liverpool·Phase 1·NCT02242799·46 enrolled

Methadone-Dolutegravir (DTG - GSK1349572) Drug Interaction Study.

Completed· GSK logo

GSK·Phase 1·NCT01467518·11 enrolled

Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir

Completed· Novartis logo

Novartis·Phase 1·NCT05236530·48 enrolled

Drug Interaction Study Between Dolutegravir and Prednisone

Completed· GSK logo

GSK·Phase 1·NCT01425099·12 enrolled

Immunodeficiency7 trials

A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults

Terminated· GSK logo

GSK·Phase 2·NCT04493216·161 enrolled

National Multicenter Trial Evaluating Two Treatments in Patients with Primary Human Immunodeficiency Virus (HIV-1) Infection

Completed·AANRS, Emerging Infectious Diseases·Phase 3·NCT02987530·101 enrolled

A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults

Terminated· GSK logo

GSK·Phase 2·NCT04900038·85 enrolled

Show 4 more trials

A Trial Evaluating Maintenance Therapy With Lamivudine (Epivir®) and Dolutegravir (Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple Highly Active Antiretroviral Therapy (HAART) (ANRS 167 Lamidol)

Completed·AANRS, Emerging Infectious Diseases·Phase 2·NCT02527096·110 enrolled

A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults

Completed· GSK logo

GSK·Phase 2·NCT04871113·62 enrolled

Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults

Completed· GSK logo

GSK·Phase 3·NCT03945981·131 enrolled

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)

Completed· GSK logo

GSK·Phase 3·NCT01910402·499 enrolled

HIV infection7 trials

Compassionate Use of Ibalizumab for the Treatment of HIV Infection

No longer available·UUniversity of Colorado, Denver··NCT02028819

Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection

Completed·IInstitut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba·Phase 3·NCT02976259·20 enrolled

DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old

Active, not recruiting·PPENTA Foundation·Phase 2/3·NCT04337450·386 enrolled

Show 4 more trials

DTG Plus 3TC for Prophylaxis of Mother-to-child Transmission of HIV Infection in Pregnant Women

Completed·FFundação Bahiana de Infectologia·Phase 3·NCT04808973·20 enrolled

Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT02384395·40 enrolled

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT02140255·1,120 enrolled

CHAPAS-5: An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa

Not yet recruiting·UUniversity College, London·Phase 3·NCT07792096·800 enrolled

HIV-16 trials

Multi Interventional Study Exploring HIV-1 Residual Replication: a Step Towards HIV-1 Eradication and Sterilizing Cure

Completed·FFederal University of São Paulo·N/A·NCT02961829·30 enrolled

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)

Terminated·IIRCCS San Raffaele·Phase 3·NCT03493568·100 enrolled

Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir

Completed· GSK logo

GSK·Phase 3·NCT01568892·30 enrolled

Show 3 more trials

Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019

Completed· GSK logo

GSK·Phase 3·NCT03016533·100 enrolled

Effect of Dolutegravir Intensification on HIV-1 Reservoirs

Completed·UUniversity of Liege·Phase 2·NCT05351684·20 enrolled

A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT05406583·48 enrolled

71 more indications

HIV5 trials

Dolutegravir in Pregnant HIV Mothers and Their Neonates

Completed·UUniversity of Liverpool·Phase 3·NCT03249181·268 enrolled

Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study

Active, not recruiting·EErasmus Medical Center··NCT04707326·2,040 enrolled

Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Use of Antiretrovirals

Recruiting·FFederal University of São Paulo·Phase 2·NCT06805656·70 enrolled

Show 2 more trials

Immediate Initiation of Antiretroviral Therapy During Acute HIV Infection

Active, not recruiting·UUniversity of California, San Francisco·Approved·NCT02656511·74 enrolled

A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofovir Alafenamide Once Daily for Virologic Suppression and Maintenance in Antiretroviral Therapy Naive Adults Living With HIV

Active, not recruiting· GSK logo

GSK·Phase 3·NCT05979311·307 enrolled

Tuberculosis5 trials

Standard Versus Double Dose Dolutegravir in Patients With HIV-associated Tuberculosis

Completed·UUniversity of Cape Town·Phase 2·NCT03851588·108 enrolled

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT04518228·205 enrolled

Dolutegravir Plus Lamivudine (DTG/3TC) Dual Therapy Versus Dolutegravir With TDF-lamivudine (DTG + TDF/3TC) Among Antiretroviral naïve People With HIV and TB Receiving Rifampin-based TB Treatment

Recruiting·JJohns Hopkins University·Phase 3·NCT06497465·150 enrolled

Show 2 more trials

Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV

Not yet recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT07124559·144 enrolled

Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05630872·30 enrolled

LAM4 trials

Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine

Completed· GSK logo

GSK·Phase 1·NCT03078556·154 enrolled

REal-Life Cohort With DOlutegravir + LAmivudina

Completed·IInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz··NCT04638686·185 enrolled

Relative Bioavailability Study of Two New Dolutegravir/Abacavir/Lamivudine Fixed Dose Combination Tablets

Completed· GSK logo

GSK·Phase 1·NCT01366547·18 enrolled

Show 1 more trial

Relative Bio-availability Study of Dolutegravir and Lamivudine Fixed Dose Combinations

Completed· GSK logo

GSK·Phase 1·NCT02738931·30 enrolled

Pilot Study4 trials

Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study

Withdrawn·PPedro Cahn·Phase 4·NCT05295394

Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study

Completed·UUniversity of Liverpool·Phase 2/3·NCT02245022·60 enrolled

Dolutegravir-Lamivudine as Dual Therapy in Naive HIV-Infected Patients: A Pilot Study

Completed·FFundación Huésped·Phase 4·NCT02211482·20 enrolled

Show 1 more trial

A Pilot Study of MONOtherapy of DOlutegravir in HIV-1 Virologically Suppressed Patients

Completed·CCalmy Alexandra·Phase 2·NCT02572947·8 enrolled

HIV Infections4 trials

Virologic Outcomes of Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine.

Completed·FFundacion SEIMC-GESIDA·Phase 2·NCT04880785·167 enrolled

A Phase 3b, Open-label, Multicenter, Continued Access Study for Participants Transitioning From ViiV Healthcare Sponsored or ViiV Healthcare Collaborative Parent Studies for HIV Treatment

Recruiting· GSK logo

GSK·Phase 3·NCT07393659·181 enrolled

Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT03048422·643 enrolled

Show 1 more trial

A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of Oral VH4524184 Coadministered With Emtricitabine and Tenofovir Alafenamide in Treatment Naive Viremic Persons With HIV-1 (INNOVATE Study)

Recruiting· GSK logo

GSK·Phase 2·NCT07202546·186 enrolled

Antiretroviral Treatment3 trials

Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)

Active, not recruiting·TThe Aurum Institute NPC·Phase 1/2·NCT05122767·92 enrolled

Open-Label Multi-Centre Randomised Switch Study to Evaluate Virological Efficacy Over 96Weeks Of 2-Drug Therapy With Dolutegravir(DTG)/Rilpivirine(RPV) Fixed Dose Combination(FDC) in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With NNRTI Mutation K103N

Completed·NNEAT ID Foundation·Phase 3·NCT05349838·140 enrolled

Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.

Unknown status·IInstituto de Investigación Hospital Universitario La Paz·Phase 2·NCT03539224·41 enrolled

Itching3 trials

HIV Reservoir Dynamics After Switching to Dolutegravir in Patients on a PI and 2 NRTI Based Regimen

Completed·HHospital Universitari Vall d'Hebron Research Institute·Phase 4·NCT02513147·44 enrolled

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)

Unknown status·CCristina Mussini·Phase 4·NCT04054089·66 enrolled

Neurological Monitoring in Patients Switching From Dolutegravir Based Regimen to Bictegravir Based Regimen

Unknown status·AAzienda Ospedaliera Universitaria Senese·Phase 3·NCT04155554·100 enrolled

Adult Subject3 trials

A Study to Evaluate the Effects of Calcium Carbonate and Ferrous Fumarate on Pharmacokinetics of Dolutegravir in Healthy Adult Subjects

Completed· GSK logo

GSK·Phase 1·NCT01762995·24 enrolled

Effect of Dolutegravir on Metformin Pharmacokinetics in Healthy Adult Subjects

Completed· GSK logo

GSK·Phase 1·NCT02064374·30 enrolled

A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects

Completed· GSK logo

GSK·Phase 1·NCT01467531·28 enrolled

Trial3 trials

The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial

Completed·EErasmus Medical Center·Phase 4·NCT02401828·134 enrolled

A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)

Completed· GSK logo

GSK·Phase 3·NCT01263015·844 enrolled

Body Composition Sub-study of the D2EFT Trial

Completed·KKirby Institute·Phase 4·NCT03675815·155 enrolled

Tics3 trials

A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

Completed· GSK logo

GSK·Phase 1·NCT02715479·14 enrolled

Pharmacokinetics of Atazanavir /Dolutegravir/Lamivudine Regimen as Maintenance Regimen

Terminated·RRadboud University Medical Center·Phase 2·NCT02566707·9 enrolled

Pharmacokinetics and Safety of DolutegravIr in Neonate

Unknown status·DDesmond Tutu TB Centre·Phase 1/2·NCT05590325·56 enrolled

Children3 trials

UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children

Completed·PPENTA Foundation·Phase 2·NCT05993767·53 enrolled

Population Pharmacokinetics of Antiretroviral in Children

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03194165·65 enrolled

Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB

Unknown status·UUniversity of KwaZulu·Phase 4·NCT04746547·20 enrolled

Drug3 trials

Triumeq As an Integrase Single Tablet Regimen in People With HIV Who Inject Drugs

Terminated·UUniversity College Dublin·Phase 4·NCT02659761·33 enrolled

Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs

Completed·RRhonda Brand·Phase 1·NCT04302896·30 enrolled

Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure

Completed·BBabafemi Taiwo·Phase 3·NCT02263326·89 enrolled

HIV-1 infection3 trials

Early Simplified: A Trial to Compare the Efficacy of Standard of Care Combination Antiretroviral Therapy With a Simplified Dolutegravir Monotherapy in Patients With a Primary HIV-1 Infection

Unknown status·UUniversity of Zurich·Phase 2·NCT02551523·101 enrolled

Evaluating the Efficacy and Safety of Dolutegravir/Lamivudine (DTG/3TC) in ART-Naïve Pregnant Women

Recruiting·FFundación Huésped·Approved·NCT07616739·210 enrolled

Phase III, Open-label, Randomized, Multicenter Trial EvaLuating the Non-inferiority of DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection

Recruiting·AANRS, Emerging Infectious Diseases·Phase 3·NCT06203132·610 enrolled

ESS2 trials

Dolutegravir Expanded Access Study

Completed· GSK logo

GSK·N/A·NCT01536873·200 enrolled

Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)

Unknown status·UUnknown Sponsor·Phase 4·NCT04826562·40 enrolled

Efficacy2 trials

Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch

Recruiting·CChelsea and Westminster NHS Foundation Trust·Phase 3·NCT04892654·150 enrolled

Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF

Completed·—·Phase 4·NCT04585737·222 enrolled

Pediatric2 trials

Dolutegravir Pediatric Liquid Formulation Study

Completed· GSK logo

GSK·Phase 1·NCT03921723·22 enrolled

Relative Bioavailability Study of a Pediatric Granule Formulation of Dolutegravir

Completed· GSK logo

GSK·Phase 1·NCT01382238·20 enrolled

Drug Interactions2 trials

Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

Completed·HHelen Reynolds·Phase 4·NCT04166474·36 enrolled

Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04272242·37 enrolled

Pregnancy2 trials

Doravirine Dose Optimisation in Pregnancy

Recruiting·UUniversity of Liverpool·Phase 4·NCT05630638·76 enrolled

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

TED2 trials

Evaluation of the Bioequivalence of a Combined Formulated Tablet

Completed· GSK logo

GSK·Phase 1·NCT01622790·66 enrolled

Bioequivalence Study to Compare Dolutegravir 50mg Film-coated Tablets

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT06450275·32 enrolled

Hepatic Impairment2 trials

Pharmacokinetics of Single-dose Dolutegravir in HIV-seronegative Subjects With Severe Hepatic Impairment Compared to Matched Controls.

Withdrawn·RRadboud University Medical Center·Phase 4·NCT03813979

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

Completed·VViriom·Phase 1·NCT03706898·36 enrolled

Efficacy and Safety2 trials

EFFICACY AND SAFETY OF A SIMPLIFICATION STRATEGY BASED ON DOLUTEGRAVIR AND DARUNAVIR / COBICISTAT VS OPTIMIZED TREATMENT IN SUPPRESSED HIV-1-INFECTED PATIENTS CARRYING ARCHIVED MULTIDRUG RESISTANCE MUTATIONS

Completed·FFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 4·NCT03683524·96 enrolled

Efficacy and Safety of a Dolutegravir-based Regimen for the Initial Management of HIV Infected Adults in Resource-limited Settings

Completed·AANRS, Emerging Infectious Diseases·Phase 3·NCT02777229·616 enrolled

Amyotrophic Lateral Sclerosis2 trials

HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT02437110·122 enrolled

Triumeq in Amyotrophic Lateral Sclerosis

Terminated·MMacquarie University, Australia·Phase 3·NCT05193994·419 enrolled

Toxicity2 trials

Efavirenz to Dolutegravir Switch in Patients With CNS Toxicity

Unknown status·SSt Stephens Aids Trust·Phase 4·NCT02285374·40 enrolled

Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity

Withdrawn·SStanford University·Phase 2/3·NCT02499978

ISS1 trial

GSK1349572 Exposure in Blood, Seminal Fluid, and Rectal Fluid and Tissue in Healthy Male Subjects

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT01459315·14 enrolled

Pulmonary Tuberculosis1 trial

Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT02583048·84 enrolled

Treatment Failure1 trial

A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen.

Completed· GSK logo

GSK·Phase 3·NCT01328041·183 enrolled

MPA1 trial

Dolutegravir Impact on Residual Replication

Completed·UUniversity of Melbourne·Phase 4·NCT02500446·40 enrolled

Adult1 trial

Dolutegravir and Darunavir Evaluation in Adults Failing Therapy

Unknown status·KKirby Institute·Phase 4·NCT03017872·831 enrolled

Gut Microbiota1 trial

Gut Microbiota, PGx and INSTIs Response

Completed·CCliniques universitaires Saint-Luc- Université Catholique de Louvain··NCT04805944·180 enrolled

Inflammation1 trial

Inflammation and Co-Infections in D²EFT

Withdrawn·KKirby Institute·Phase 4·NCT04183738

Cardiovascular1 trial

Cardiovascular Risk in HIV Patients Switching From a Boosted Protease Inhibitor (PI) to Dolutegravir (DTG)

Completed·SSt Stephens Aids Trust·Phase 4·NCT02098837·415 enrolled

Metabolic Disease1 trial

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 Load

Completed·FFundacion SEIMC-GESIDA·Phase 4·NCT05898841·63 enrolled

Resistance1 trial

Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance

Recruiting·UUniversity of Nairobi·Phase 3·NCT06747507·392 enrolled

Central Nervous System1 trial

A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects

Completed· GSK logo

GSK·Phase 3·NCT01499199·13 enrolled

Single Dose1 trial

Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam

Completed·TTobira Therapeutics, Inc.·Phase 1·NCT01827540·20 enrolled

Medication1 trial

Effect on HIV Medications on EPC Cells

Completed·SSabyasachi Sen··NCT03782142·22 enrolled

HIV-Infected Individuals1 trial

Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals

Completed·TThomas Benfield·Phase 4·NCT04904406·81 enrolled

PLWH1 trial

Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully

Recruiting·CCentre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida·Phase 2·NCT06774872·408 enrolled

Observational Study1 trial

Prospective Non-Interventional Observational Study of Use of TRIUMEQ and Corresponding Monitoring Measures in Clinical Practice in Germany

Completed· GSK logo

GSK··NCT02342769·403 enrolled

Maintenance Therapy1 trial

DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV:

Completed·FFundacion SEIMC-GESIDA·Phase 4·NCT04884139·554 enrolled

ART1 trial

Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects

Completed· GSK logo

GSK·Phase 3·NCT01449929·488 enrolled

Bone Health1 trial

Effect of Reducing Nucleotide Exposure on Bone Health (ReNew)

Withdrawn·PPhilip Grant·Phase 2·NCT03549689

Imaging1 trial

ENLIGHTEN: Establishing Novel Antiretroviral (ARV) Imaging for Hair to Elucidate Non-Adherence

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT03218592·36 enrolled

CAR1 trial

Evaluation of Third-line cART Regimen in Cambodia (3DICAM)

Unknown status·AANRS, Emerging Infectious Diseases·Phase 2·NCT03602690·54 enrolled

Pediatrics1 trial

Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Recruiting· GSK logo

GSK·Phase 1/2·NCT05674656·20 enrolled

Tenofovir1 trial

Changes in Weight, Body Composition and Metabolic Parameters After Discontinuing Dolutegravir or Tenofovir Disproxil

Unknown status·TThomas Benfield·Phase 4·NCT04903847·126 enrolled

Gastrointestinal1 trial

Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults

Completed·UUniversity of North Carolina, Chapel Hill··NCT02218320·20 enrolled

Advanced1 trial

Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir

Unknown status·JJuan A. Arnaiz·Phase 4·NCT02337322·104 enrolled

Renal Impairment1 trial

Dolutegravir Renal Impairment Study

Completed· GSK logo

GSK·Phase 1·NCT01353716·16 enrolled

Solid Organ Transplant1 trial

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 Patients

Completed·FFundacion Clinic per a la Recerca Biomédica·Phase 4·NCT03360682·19 enrolled

Insulin Sensitivity1 trial

The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers

Completed·CChelsea and Westminster NHS Foundation Trust·Phase 1·NCT04771754·16 enrolled

Women1 trial

Effect of Dolutegravir on Etonogestrel Levels in HIV-infected Women in Botswana

Completed·—··NCT03336346·148 enrolled

Contraception1 trial

Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV

Unknown status·BBotswana Harvard AIDS Institute Partnership·Phase 4·NCT04910711·140 enrolled

Infants1 trial

Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana

Completed·—··NCT04862975·164 enrolled

End-Stage Renal Disease1 trial

Assessment of Dolutegravir Removed by Hemodialysis in HIV-infected Patients With End-stage Renal Disease

Completed·FFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 4·NCT02487706·5 enrolled

Monotherapy1 trial

Study to Evaluate the Efficacy of MONotherapy of TiviCAY® Versus a Triple Therapy in HIV-1-infected Patients

Terminated·—·Phase 3·NCT02596334·158 enrolled

CLE1 trial

Nucleosides And Darunavir/Dolutegravir In Africa

Unknown status·MMakerere University·Phase 3·NCT03988452·465 enrolled

Prospective1 trial

A Prospective, Non-interventional Study of the Use of Dolutegravir as Part of Combination Antiretroviral Therapy in Routine Daily Practice in Germany

Completed· GSK logo

GSK··NCT02076386·411 enrolled

First-line1 trial

ADVANCE Study of DTG + TAF + FTC vs DTG + TDF + FTC and EFV + TDF+FTC in First-line Antiretroviral Therapy

Completed·PProfessor Francois Venter·Phase 3·NCT03122262·1,110 enrolled

Mortality1 trial

Impact of a Dolutegravir-based Regimen on Early Mortality of AIDS Patients

Completed·FFundação Bahiana de Infectologia·Phase 2/3·NCT01837277·186 enrolled

Fed1 trial

Phase 4 Study of Dolutegravir (DTG) in Russian Federation

Completed· GSK logo

GSK·Phase 4·NCT03314064·43 enrolled

Neurocognitive Dysfunction1 trial

Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT02519777·191 enrolled

Cardiovascular Disease1 trial

Contribution of Dolutegravir to Obesity and Cardiovascular Disease

Completed·—·Phase 4·NCT04340388·10 enrolled

Randomised Controlled Trial1 trial

Tenofovir-lamivudine-dolutegravir Combination as Second-line ART: a Randomised Controlled Trial

Completed·UUniversity of Cape Town·Phase 2·NCT03991013·192 enrolled

Low Bone Mineral Density1 trial

Multicentre Study To Assess Changes In Bone Mineral Density Of The Switch From Protease Inhibitors To Dolutegravir In HIV-1-Infected Subjects With Low Bone Mineral Density

Completed·FFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 3·NCT01966822·75 enrolled

Effectiveness1 trial

'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor

Completed· GSK logo

GSK··NCT04019873·774 enrolled

Prophylaxis1 trial

The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis

Completed·AAndrew Carr·Phase 4·NCT02211690·100 enrolled

Weight Gain1 trial

Early Metabolic Effects of Antiretroviral Drugs in Healthy Volunteers: A Phase 2 Randomized Study

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05652478·120 enrolled

Pulmonary1 trial

A Prospective Phase Ib/IIa, Active-controlled, Randomized, Open-label Study to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of Multiple Oral Doses of BTZ-043 Tablets in Subjects With Newly Diagnosed, Uncomplicated, Smear-positive, Drug-susceptible Pulmonary Tuberculosis

Completed·MMichael Hoelscher·Preclinical·NCT04044001·78 enrolled

Pediatric HIV Infection1 trial

Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention

Recruiting·BBrigham and Women's Hospital·Phase 1·NCT06281834·25 enrolled

Unspecified10 trials

Dolutegravir in Reservoirs

Terminated·EEmory University·Phase 4·NCT02924389·22 enrolled

ODYSSEY (PENTA 20)

Completed·PPENTA Foundation·Phase 2/3·NCT02259127·792 enrolled

A Clinical Study Investigating Rifampicin and Dolutegravir in Combination in Healthy Volunteers

Unknown status·SSt. Stephens Clinical Research·Phase 1·NCT03199690·16 enrolled

Show 7 more trials

Second-line Switch to Dolutegravir Study

Completed·UUniversity of Nairobi·Phase 4·NCT04229290·795 enrolled

SSAT061: PK of DTG and EVT/COBI in Healthy Volunteers

Completed·SSt Stephens Aids Trust·Phase 1·NCT02219217·17 enrolled

Dolutegravir in Real Life in Lesotho

Completed·SSwiss Tropical & Public Health Institute··NCT04238767·1,433 enrolled

Bioavailability Study of 10 Milligram (mg) and 5 mg Tablets Versus Conventional Tablets of Dolutegravir

Completed· GSK logo

GSK·Phase 1·NCT03095638·38 enrolled

ANRS 12372 MODERATO Study

Unknown status·AANRS, Emerging Infectious Diseases·Phase 3·NCT04022967·480 enrolled

Bioavailability Study of a Dolutegravir Dispersible Tablet and Effect of Different Types of Water on the Dispersible Tablet in Healthy Volunteers

Completed· GSK logo

GSK·Phase 1·NCT02185300·15 enrolled

A Drug-Drug Interaction Study of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT07532304·16 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 9, 2016

TIVICAY

NDA NDA204790

Jun 12, 2020

TIVICAY PD

NDA NDA213983

Sources

References

[1]
ClinicalTrials.gov — 158 trial records for Dolutegravir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tivicay drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dolutegravir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dolutegravir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213983). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tivicay. U.S. Food & Drug Administration.
[7]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Integrase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GSK

Patent Landscape[6]

Patent Cliff

Oct 5, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8129385Oct 5, 2027