dolutegravir: Clinical Trials

156 completed, 19 recruiting, 19 unknown, 12 terminated. 63 Phase 1, 53 Phase 3, 47 Phase 2, 47 Phase 4, 5 Not applicable.

By phase and status

Phase	Trials	Status
Phase 1	63	Completed 54, Recruiting 4, Unknown 2, Active not recruiting 1, Terminated 1, Withdrawn 1
Phase 3	53	Completed 37, Recruiting 6, Active not recruiting 3, Terminated 3, Unknown 2, Not yet recruiting 1, Withdrawn 1
Phase 2	47	Completed 24, Recruiting 8, Terminated 5, Unknown 5, Active not recruiting 2, Withdrawn 2, Not yet recruiting 1
Phase 4	47	Completed 24, Unknown 11, Recruiting 4, Withdrawn 3, Not yet recruiting 2, Active not recruiting 1, Enrolling by invitation 1, Terminated 1
Not applicable	5	Completed 5
Early Phase 1	2	Completed 2

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa Dolutegravir (DTG), Abacavir (ABC), Lamivudine (3TC) - HIV Infection	Phase 3	Not yet recruiting	University College, London	800	2026-11-01	2026-08-28
Sleep Outcomes and Multidimensional Sleep Assessment - a Randomized Trial of Dolutegravir- vs Doravirine-based Antiretroviral Therapy in People Living With HIV Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Doravirine 100mg, Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Dolutegravir 50mg - HIV (Human Immunodeficiency Virus), Sleep	Phase 4	Not yet recruiting	University of Witwatersrand, South Africa	40	2026-10-05	2026-10-06
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV Rifapentine, Isoniazid, Dolutegravir - Tuberculosis	Phase 1 / Phase 2	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	144	2026-09-28	2026-11-02
Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study Dolutegravir (DTG) AND Tenofovir alafenamide (TAF), Tenofovir Disoproxil Fumarate, Dolutegravir - Healthy Volunteer, Weight Gain	Phase 2	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	120	2026-09-24	2026-09-29
Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO], TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) - HIV-1-infection	Phase 4	Recruiting	Fundación Huésped	210	2026-09-10	2026-09-18
A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment Fostemsavir, Dolutegravir (DTG)/ Lamivudine (3TC) - HIV Infections	Phase 3	Recruiting	ViiV Healthcare	181	2026-07-21	2026-08-14
Multi Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals Maraviroc, Dolutegravir, Dendritic Cell Vaccine - Hiv, HIV I Infection	Phase 2	Recruiting	Federal University of São Paulo	70	2026-07-15	2026-08-19
A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646) Bictegravir/emtricitabine/tenofovir alafenamide, Dolutegravir, MK4646 - Healthy	Phase 1	Completed	Merck Sharp & Dohme LLC	16	2026-05-11	2026-08-25
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection Combination of Dolutegravir + Tenofovir DF for treatment of HTLV-1 infection, Dolutegravir (DTG) - HTLV-1 Infection, HTLV I Associated Myelopathies	Phase 2	Recruiting	Carlos Brites	146	2026-05-07	2026-06-02
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) VH4524184, Emtricitabine (FTC) and tenofovir alafenamide (TAF) Fixed Dose Combination (FDC) tablets, Dolutegravir / Lamivudine (DTG/3TC) - HIV Infections	Phase 2	Recruiting	ViiV Healthcare	186	2026-02-11	2026-07-23
Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment Dolutegravir 50mg Tab, Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO], Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC) - Tuberculosis, HIV	Phase 3	Recruiting	Johns Hopkins University	150	2025-09-18	2026-09-11
Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance Dolutegravir Pill, Darunavir+Ritonavir - HIV-1-infection	Phase 3	Recruiting	University of Nairobi	392	2025-09-01	2025-09-11
Research on the Psychological Status of Patients With HIV-1 Infection All kinds of INSTI medications, All kinds of conventional medications - HIV-1-infection, Anxiety Depression		Not yet recruiting	Shanxi Bethune Hospital	500	2025-08-01	2025-07-23
Switch to Dolutegravir Plus Lamivudine Dual-Therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH) Dolutegravir 50 MG plus lamivudine 300 MG； Dolutegravir/lamivudine (50 MG/300 MG) - HIV, HIV-1	Phase 4	Recruiting	UBATEC	50	2025-07-31	2025-09-12
Effect of Dolutegravir Compared With Darunavir/Cobicistat on the Severity of Neuropsychiatric Effects al 12 Weeks in Antirretroviral Treatment-Naive Adults. Dolutegravir (DTG), Darunavir/Cobicistat (FDC) - HIV, Insomnia	Phase 4	Unknown	Instituto Mexicano del Seguro Social	140	2025-06-19	2025-06-26
Doravirine/Lamivudine (DOR/3TC) as a Maintenance ART in Comparison With Dolutegravir/Lamivudine (DTG/3TC) in PLWH Successfully Doravirine 100Mg Tab and Lamivudine 300 Mg Tab, Dolutegravir 50mg Tab and Lamivudine 300 Mg Tab - HIV-1-infection	Phase 2	Recruiting	Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	408	2025-04-30	2025-06-11
Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI, Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR) - HIV Infections, HBV Coinfection	Phase 2	Not yet recruiting	ANRS, Emerging Infectious Diseases	140	2025-02-01	2025-02-05
DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection Doravirine + tenofovir DF + lamivudine, Dolutegravir + tenofovir DF + lamivudine or emtricitabine - HIV-1-infection	Phase 3	Recruiting	ANRS, Emerging Infectious Diseases	610	2025-01-27	2026-07-27
Efficacy and Safety of DTG/3TC in Treatment-naïve HIV-1 Infected Patients DTG + 3TC FDC - HIV		Enrolling by invitation	Chungnam National University Hospital	200	2025-01-24	2025-04-15
UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen, Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF) - HIV Infection	Phase 2	Completed	PENTA Foundation	53	2024-12-11	2026-03-04

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Conditions studied

Acquired Immunodeficiency Syndrome (78)  ·  HIV Infections (66)  ·  Infections (43)  ·  Tuberculosis (11)  ·  Amyotrophic Lateral Sclerosis (3)  ·  Malaria (3)  ·  Body Weight Changes (2)  ·  Bone Diseases, Metabolic (2)  ·  Coinfection (2)  ·  Hepatitis (2)  ·  Latent Tuberculosis (2)  ·  Osteoporosis (2)  ·  Tuberculosis, Pulmonary (2)  ·  Weight Gain (2)  ·  Anxiety Disorders (1)

Sponsors

ViiV Healthcare (62)  ·  National Institute of Allergy and Infectious Diseases (NIAID) (12)  ·  GlaxoSmithKline (8)  ·  ANRS, Emerging Infectious Diseases (7)  ·  St Stephens Aids Trust (5)  ·  University of North Carolina, Chapel Hill (5)  ·  University of Liverpool (4)  ·  Federal University of São Paulo (3)  ·  Fundacion SEIMC-GESIDA (3)  ·  Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia (3)  ·  Fundación Huésped (3)  ·  Gilead Sciences (3)  ·  Kirby Institute (3)  ·  PENTA Foundation (3)  ·  Radboud University Medical Center (3)

Countries

United States (94)  ·  South Africa (41)  ·  Spain (38)  ·  France (31)  ·  Italy (25)  ·  Germany (24)  ·  United Kingdom (24)  ·  Canada (22)  ·  Argentina (21)  ·  Thailand (21)  ·  Brazil (20)  ·  Russia (16)  ·  Australia (15)  ·  Belgium (15)  ·  Uganda (15)

Top investigators

Adriano Lazzarin, Prof (2)  ·  Babafemi Taiwo, MBBS (2)  ·  Mark Mirochnick, MD (2)  ·  Mohammed Lamorde, PhD, MBChB (2)  ·  Philip Grant, MD (2)  ·  Saye Khoo (2)  ·  Adrie Bekker, Prof (1)  ·  Alessandra Bandera, P.I. (1)  ·  Alessandro Bartoloni, P.I. (1)  ·  Alla Andreeva, PhD (1)  ·  Anchalee Avihingsanon, MD, PhD (1)  ·  Andrea Andreoni, P.I. (1)

Results publications

PMID 24446523, PMID 29239893, PMID 31307948, PMID 31350995, PMID 34817414, PMID 34913844, PMID 40134635, PMID 16470119, PMID 16988514, PMID 18366444, PMID 18795962, PMID 18989231, PMID 20002783, PMID 20632458, PMID 21283017, PMID 22083071, PMID 22129166, PMID 23305215, PMID 23392467, PMID 23817375, PMID 23824675, PMID 23830355, PMID 23899439, PMID 23979733, PMID 24074642, PMID 24096683, PMID 24195548, PMID 24698485, PMID 24798770, PMID 24838177, PMID 24944232, PMID 25155604, PMID 25162818, PMID 25261418, PMID 25321146, PMID 25407158, PMID 25950206, PMID 25959631, PMID 26202768, PMID 26262777, PMID 26424673, PMID 26856824, PMID 26918544, PMID 26974526, PMID 27540363, PMID 28219610, PMID 28537061, PMID 28729158, PMID 28867499, PMID 29029135

NIH funding

2015 (4), 2017 (4), 2014 (3), 2016 (3), 2009 (1), 2018 (1), 2019 (1), 2023 (1), 2025 (1), 2UM1AI068636 (1), K23AI124913 (1), P30AI094189 (1), R01AI122301 (1), R01AI122319 (1), R01AI152142 (1)