Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate dolutegravir (GSK1349572), primarily targeting adult and pediatric HIV infections, opportunistic co-infections such as latent tuberculosis, and outcomes like weight gain, lipodystrophy, and renal insufficiency. Sponsored by prominent academic and research entities including Johns Hopkins University, Brigham and Women's Hospital, and the University of Cape Town, these protocols span completed, actively recruiting, and not yet recruiting stages. Ultimately, these evaluations reflect an extensive effort to characterize the efficacy, safety, and pharmacokinetic profile of dolutegravir across diverse patient populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07393659 RECRUITING
HIV Infections
ViiV Healthcare
 2026-07-21 PHASE3
NCT07792096 NOT_YET_RECRUITING
HIV Infection
University College, London
 2026-11 PHASE3
NCT07711223 RECRUITING
Infection, Human Immunodeficiency Virus
Jiangsu Aidea Pharmaceutical Group Co., Ltd.
 2025-11-07 PHASE1; PHASE2
NCT07616739 NOT_YET_RECRUITING
HIV-1-infection
Fundación Huésped
 2026-06-15 PHASE4
NCT05630638 RECRUITING
HIV
University of Liverpool
 2023-10-10 PHASE4
NCT07555431 RECRUITING
HTLV-1 Infection; HTLV I Associated Myelopathies; HTLV I Associated T Cell Leukemia Lymphoma; Neuritis
Carlos Brites
 2026-05-07 PHASE2
NCT06497465 RECRUITING
Tuberculosis; HIV
Johns Hopkins University
 2025-09-18 PHASE3
NCT02140255 RECRUITING
HIV Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2015-01-23 PHASE1; PHASE2
NCT05652478 RECRUITING
Healthy Volunteer; Weight Gain; Metabolic Effects; Integrase Strand Transfer Inhibitors
National Institute of Allergy and Infectious Diseases (NIAID)
 2026-09-09 PHASE2
NCT07124559 NOT_YET_RECRUITING
Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2026-10-15 PHASE1; PHASE2
NCT06203132 RECRUITING
HIV-1-infection
ANRS, Emerging Infectious Diseases
 2025-01-27 PHASE3
NCT07110831 NOT_YET_RECRUITING
Depression; HIV
University of Ibadan
 2025-08-14 PHASE4
NCT07673965 NOT_YET_RECRUITING
HIV (Human Immunodeficiency Virus); Sleep
University of Witwatersrand, South Africa
 2026-08-20 PHASE4
NCT05373758 RECRUITING
HIV Infections; AIDS; Virologic Failure
Massachusetts General Hospital
 2024-02-07
NCT07202546 RECRUITING
HIV Infections
ViiV Healthcare
 2026-02-11 PHASE2
NCT02656511 ACTIVE_NOT_RECRUITING
HIV
University of California, San Francisco
 2015-12 PHASE4
NCT06805656 RECRUITING
Hiv; HIV I Infection
Federal University of São Paulo
 2026-07-15 PHASE2
NCT06281834 RECRUITING
Pediatric HIV Infection; Latent Tuberculosis
Brigham and Women's Hospital
 2024-11-15 PHASE1
NCT06774872 RECRUITING
HIV-1-infection
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
 2025-04-30 PHASE2
NCT07031063 RECRUITING
HIV Infection; Metabolic Syndrome; Antiretroviral Treatment
Instituto Mexicano del Seguro Social
 2025-04-01 PHASE4
NCT06967753 RECRUITING
HIV; HIV-1
UBATEC
 2025-07-31 PHASE4
NCT06747507 RECRUITING
HIV-1-infection
University of Nairobi
 2025-09-01 PHASE3
NCT04892654 RECRUITING
HIV-1-infection
Chelsea and Westminster NHS Foundation Trust
 2022-08-17 PHASE3
NCT07532304 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2026-05-11 PHASE1
NCT06485154 RECRUITING
HIV Prevention
University of Witwatersrand, South Africa
 2024-06-01 PHASE4
NCT05674656 RECRUITING
HIV Infections
ViiV Healthcare
 2023-07-06 PHASE1; PHASE2
NCT06580873 NOT_YET_RECRUITING
HIV-1-infection; Opioid Use Disorder
Saskatchewan Health Authority - Regina Area
 2024-09-30 PHASE4
NCT06250504 RECRUITING
HIV Infections
Africa Health Research Institute
 2024-02-27 PHASE3
NCT05979311 ACTIVE_NOT_RECRUITING
HIV; HIV Infections
ViiV Healthcare
 2024-02-21 PHASE3
NCT05393193 ACTIVE_NOT_RECRUITING
HIV
Harvard School of Public Health (HSPH)
 2022-07-04 PHASE4
NCT06787976 UNKNOWN
HIV; Insomnia; Anxiety
Instituto Mexicano del Seguro Social
 2025-06-19 PHASE4
NCT05122026 ACTIVE_NOT_RECRUITING
HIV Seropositivity; Pregnancy; Tuberculosis Infection
The Aurum Institute NPC
 2024-01-17 PHASE1; PHASE2
NCT04337450 ACTIVE_NOT_RECRUITING
HIV Infections
PENTA Foundation
 2022-04-22 PHASE2; PHASE3
NCT05917509 COMPLETED
HIV Infections
ViiV Healthcare
 2023-07-06 PHASE3
NCT05493969 UNKNOWN
Acquired Immunodeficiency Syndrome
Shanghai Public Health Clinical Center
 2022-08 PHASE4
NCT04746547 UNKNOWN
Tuberculosis; Hiv
University of KwaZulu
 2021-08-19 PHASE4
NCT05898841 COMPLETED
HIV Infections; Fatty Liver Disease
Fundacion SEIMC-GESIDA
 2023-05-26 PHASE4
NCT05122767 ACTIVE_NOT_RECRUITING
Tuberculosis; HIV
The Aurum Institute NPC
 2023-05-24 PHASE1; PHASE2
NCT05193994 TERMINATED
Amyotrophic Lateral Sclerosis
Macquarie University, Australia
 2022-02-24 PHASE3
NCT03731559 RECRUITING
HIV/TB Coinfection
The HIV Netherlands Australia Thailand Research Collaboration
 2019-06-25 PHASE2
NCT05993767 COMPLETED
HIV Infection
PENTA Foundation
 2024-12-11 PHASE2
NCT06658977 TERMINATED
Amyotrophic Lateral Sclerosis; ALS
Macquarie University, Australia
 2024-11-15 PHASE3
NCT05630872 COMPLETED
HIV-associated Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2024-02-13 PHASE2
NCT06438146 UNKNOWN
Obesity; HIV Infections
Brigham and Women's Hospital
 2024-05-02 PHASE4
NCT05406583 COMPLETED
HIV
National Institute of Allergy and Infectious Diseases (NIAID)
 2022-10-05 PHASE1
NCT04022967 UNKNOWN
HIV-1-infection
ANRS, Emerging Infectious Diseases
 2020-09-21 PHASE3
NCT03016533 COMPLETED
HIV Infections
ViiV Healthcare
 2017-06-06 PHASE3
NCT05289986 TERMINATED
Hiv
Chelsea and Westminster NHS Foundation Trust
 2023-11-21 PHASE4
NCT05590325 UNKNOWN
Hiv
Desmond Tutu TB Centre
 2022-09-12 PHASE1; PHASE2
NCT04880395 COMPLETED
HIV-1-infection
Fundación Huésped
 2021-05-17 PHASE4
NCT06281834 Not yet recruiting
Pediatric HIV Infection|Latent Tuberculosis
Brigham and Women''s Hospital|APIN Public Health Initiatives|University of Cape Town
 2024-05 Phase 1
NCT07618507 COMPLETED
HIV; HIV -1 Infection
Federal University of São Paulo
 2022-04-13
NCT06629480 COMPLETED
Antiretroviral Treatment; HIV Infection; Metabolic Cardiovascular Syndrome
Instituto Mexicano del Seguro Social
 2021-06-25
NCT04884139 COMPLETED
HIV-1-infection
Fundacion SEIMC-GESIDA
 2021-07-14 PHASE4
NCT04166474 COMPLETED
Hiv; Tuberculosis
Helen Reynolds
 2021-11-18 PHASE4
NCT06450275 COMPLETED
HIV Infections
Humanis Saglık Anonim Sirketi
 2024-01-03 PHASE1
NCT03675815 COMPLETED
HIV Infections
Kirby Institute
 2019-12-05 PHASE4
NCT05122026 Recruiting
HIV Seropositivity|Pregnancy|Tuberculosis Infection
The Aurum Institute NPC|Johns Hopkins University|Weill Medical College of Cornell University|University of Washington
 2024-01-17 Phase 1|Phase 2
NCT04771754 COMPLETED
HIV-1-infection on Healthy Volunteers
Chelsea and Westminster NHS Foundation Trust
 2022-03-20 PHASE1
NCT04904406 COMPLETED
Hiv; HIV Infections; HIV Cardiomyopathy; Weight Change, Body; HIV Lipodystrophy; Cardiovascular Diseases
Thomas Benfield
 2020-10-22 PHASE4
NCT04826562 UNKNOWN
Human Immunodeficiency Virus
Saint Michael's Medical Center
 2021-09-26 PHASE4
NCT04549467 COMPLETED
Hiv; HIV-1-infection
Fundacion IDEAA
 2020-11-17 PHASE4
NCT04808973 COMPLETED
HIV Infections; Pregnancy Related; Mother to Child Transmission
Fundação Bahiana de Infectologia
 2021-07-01 PHASE3
NCT04910711 UNKNOWN
Human Immunodeficiency Virus; Contraception; ART
Botswana Harvard AIDS Institute Partnership
 2021-10-21 PHASE4
NCT04585737 COMPLETED
HIV I Infection
Charlotte-Paige Rolle, MD
 2020-10-05 PHASE4
NCT04431518 COMPLETED
HIV/AIDS; ESRD
Indiana University
 2021-04-23 PHASE4
NCT05069688 Recruiting
Pediatric HIV Infection|Tuberculosis Infection
Brigham and Women''s Hospital|APIN Public Health Initiatives|University of Cape Town
 2023-07-07 Phase 1
NCT04880785 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2021-07-28 PHASE2
NCT04133012 COMPLETED
HIV-1 Infection
ANRS, Emerging Infectious Diseases
 2020-02-10
NCT05122767 Recruiting
Tuberculosis|HIV
The Aurum Institute NPC|Johns Hopkins University
 2023-05-24 Phase 1|Phase 2
NCT03727152 COMPLETED
HIV
The HIV Netherlands Australia Thailand Research Collaboration
 2019-05-01 PHASE3
NCT04979468 UNKNOWN
HIV-1-infection
Societa' Italiana Di Malattie Infettive E Tropicali
 2021-03-23 PHASE3
NCT05489406 COMPLETED
Hiv
Radboud University Medical Center
 2022-10-06 PHASE1
NCT04034862 COMPLETED
HIV Infections
University of Liege
 2019-10-01 PHASE3
NCT04903847 UNKNOWN
Hiv; HIV Infections; HIV Lipodystrophy; Osteoporosis; Renal Insufficiency; Weight Gain; Obesity
Thomas Benfield
 2021-02-02 PHASE4
NCT04183738 WITHDRAWN
HIV-infection/Aids; Human Herpesvirus 4 Infections; Cytomegalovirus Infections; Human Herpesvirus 8 Infection; Human Papilloma Virus
Kirby Institute
 2021-02-01 PHASE4
NCT03435146 COMPLETED
Respiratory Tract Infections; HIV Infections
The Aurum Institute NPC
 2018-01-18 PHASE1; PHASE2
NCT04900038 TERMINATED
HIV Infections
ViiV Healthcare
 2021-08-18 PHASE2
NCT02437110 COMPLETED
Amyotrophic Lateral Sclerosis
National Institute of Neurological Disorders and Stroke (NINDS)
 2019-04-01 PHASE1
NCT03017872 UNKNOWN
HIV Infections
Kirby Institute
 2017-11-23 PHASE4
NCT04871113 COMPLETED
HIV Infections
ViiV Healthcare
 2021-06-22 PHASE2
NCT05236530 COMPLETED
Malaria
Novartis Pharmaceuticals
 2022-03-09 PHASE1
NCT04493216 TERMINATED
HIV Infections
ViiV Healthcare
 2020-11-18 PHASE2
NCT05351684 COMPLETED
HIV-1-infection
University of Liege
 2019-01-01 PHASE2
NCT05295394 WITHDRAWN
HIV-1 Infection
Pedro Cahn
 2019-05-22 PHASE4
NCT04340388 COMPLETED
HIV-1-infection; Antiviral Drug Adverse Reaction; Vascular Diseases; Cardiovascular Abnormalities; Abnormality of Adipose Tissue; Body Weight Changes; Body Fat Disorder; HIV-Associated Lipodystrophy Syndrome
Augusta University
 2020-09-17 PHASE4
NCT04051970 TERMINATED
HIV-1-infection
ANRS, Emerging Infectious Diseases
 2019-11-27 PHASE3
NCT03122262 COMPLETED
HIV-1 Infection
Professor Francois Venter
 2017-01-16 PHASE3
NCT03991013 COMPLETED
HIV Infections
University of Cape Town
 2019-08-08 PHASE2
NCT03602690 UNKNOWN
HIV/AIDS
ANRS, Emerging Infectious Diseases
 2018-10-04 PHASE2
NCT04044001 COMPLETED
Pulmonary Tuberculoses; Other Specified Pulmonary Tuberculosis
Michael Hoelscher
 2019-11-15 PHASE1; PHASE2
NCT04311944 UNKNOWN
HIV-1-infection
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
 2020-09-01
NCT05006170 UNKNOWN
Pediatric HIV Infection
Chulalongkorn University
 2021-08-03 PHASE2
NCT03547908 COMPLETED
HIV-1/HBV Co-Infection
Gilead Sciences
 2018-05-30 PHASE3
NCT07002229 COMPLETED
Healthy
Henan Genuine Biotech Co., Ltd.
 2021-12-09 PHASE1
NCT03851588 COMPLETED
HIV Infections; Tuberculosis
University of Cape Town
 2019-12-19 PHASE2
NCT04295460 UNKNOWN
HIV Infection
Hospitales Universitarios Virgen del Rocío
 2020-03-10 PHASE4
NCT03813979 WITHDRAWN
HIV-1-infection; Hepatic Impairment
Radboud University Medical Center
 2020-11-15 PHASE4
NCT04272242 TERMINATED
HIV Infection; LTBI
National Institute of Allergy and Infectious Diseases (NIAID)
 2021-02-27 PHASE2
NCT03760458 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2020-09-09 PHASE1; PHASE2
NCT03682848 COMPLETED
HIV Infections
ViiV Healthcare
 2019-05-06 PHASE3
NCT05349838 COMPLETED
HIV-1-infection
NEAT ID Foundation
 2018-11-05 PHASE3
NCT04538040 COMPLETED
HIV-1-infection
Quest Clinical Research
 2019-12-19 PHASE4
NCT04302896 COMPLETED
Medication Adherence; HIV
Rhonda Brand
 2020-08-31 EARLY_PHASE1
NCT04229290 COMPLETED
HIV-1-infection
University of Nairobi
 2020-02-12 PHASE4
NCT04857892 COMPLETED
HIV Infections
ViiV Healthcare
 2021-04-21 PHASE1
NCT02659761 TERMINATED
Human Immunodeficiency Virus
University College Dublin
 2016-11 PHASE4
NCT05030025 COMPLETED
HIV-1-infection
Mylan Inc.
 2021-08-01 EARLY_PHASE1
NCT02771249 COMPLETED
HIV Infected Population With Latent Tuberculosis
National Institutes of Health Clinical Center (CC)
 2016-06-03 PHASE1
NCT03683524 COMPLETED
HIV-1 Infection
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2018-11-19 PHASE4
NCT01837277 COMPLETED
Severely Immunocompromised HIV Patients
Fundação Bahiana de Infectologia
 2017-12-15 PHASE2; PHASE3
NCT04827134 COMPLETED
HIV Infections
ViiV Healthcare
 2021-05-07 PHASE1
NCT03549689 WITHDRAWN
HIV/AIDS; HIV-1-infection; Osteopenia
Philip Grant
 2019-08-01 PHASE2
NCT03539224 UNKNOWN
HIV-1-infection
Instituto de Investigación Hospital Universitario La Paz
 2017-11-02 PHASE2
NCT04021290 COMPLETED
HIV Infections
ViiV Healthcare
 2019-11-11 PHASE3
NCT03982277 COMPLETED
Tuberculosis
Makerere University
 2019-04-30 PHASE2
NCT02259127 COMPLETED
HIV Infection
PENTA Foundation
 2016-09-20 PHASE2; PHASE3
NCT01302847 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2011-04-20 PHASE1; PHASE2
NCT03249181 COMPLETED
HIV-1-infection; Pregnancy Related
University of Liverpool
 2018-01-22 PHASE3
NCT03048422 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2018-01-19 PHASE3
NCT03988452 UNKNOWN
Human Immunodeficiency Virus
Makerere University
 2019-07-30 PHASE3
NCT04147715 COMPLETED
Healthy Volunteer
Shionogi
 2019-10-09 PHASE1
NCT03512964 COMPLETED
Human Immunodeficiency Virus
Johns Hopkins University
 2016-11-29
NCT04155554 UNKNOWN
HIV-1-infection
Azienda Ospedaliera Universitaria Senese
 2020-01-29 PHASE3
NCT03685500 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2018-12-04 PHASE4
NCT03360682 COMPLETED
HIV-1-infection; Solid Organ Transplant
Fundacion Clinic per a la Recerca Biomédica
 2018-04-13 PHASE4
NCT03945981 COMPLETED
HIV Infections
ViiV Healthcare
 2019-07-02 PHASE3
NCT02384395 COMPLETED
HIV; Acute HIV Infection
University of North Carolina, Chapel Hill
 2015-09
NCT04054089 COMPLETED
HIV Infections
Cristina Mussini
 2020-01-23 PHASE4
NCT03732625 UNKNOWN
HIV Infections
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
 2019-05 PHASE4
NCT02519777 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2016-04-21 PHASE4
NCT02337322 UNKNOWN
Acquired Immune Deficiency Syndrome Virus
Juan A. Arnaiz
 2015-03-31 PHASE4
NCT04225325 UNKNOWN
HIV-1-infection
ADRIANO LAZZARIN, MD
 2018-05-07 PHASE4
NCT02924389 TERMINATED
HIV
Emory University
 2016-09 PHASE4
NCT03984838 COMPLETED
HIV Infections
ViiV Healthcare
 2019-06-17 PHASE1
NCT02987530 COMPLETED
HIV-1 Infection
ANRS, Emerging Infectious Diseases
 2017-04-11 PHASE3
NCT03921723 COMPLETED
HIV Infections
ViiV Healthcare
 2019-05-07 PHASE1
NCT03224338 COMPLETED
HIV II Infection
Blueclinical, Ltd.
 2017-04-05 PHASE2
NCT03033836 COMPLETED
HIV Infections
Fundación Huésped
 2015-12 PHASE4
NCT03446573 COMPLETED
HIV Infections
ViiV Healthcare
 2018-01-18 PHASE3
NCT03067285 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2017-09-08 PHASE4
NCT03706898 COMPLETED
HIV-1-infection; Hepatic Impairment
Viriom
 2018-10-01 PHASE1
NCT03816696 COMPLETED
HIV Infections
ViiV Healthcare
 2019-01-23 PHASE1
NCT02961829 COMPLETED
Chronic Infection; HIV
Federal University of São Paulo
 2015-07
NCT02583048 COMPLETED
Tuberculosis; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2016-08-15 PHASE2
NCT02245022 COMPLETED
HIV; Pregnancy
University of Liverpool
 2017-03-14 PHASE2; PHASE3
NCT03110380 COMPLETED
HIV-1-infection
Gilead Sciences
 2017-06-12 PHASE3
NCT03218592 COMPLETED
HIV/AIDS
University of North Carolina, Chapel Hill
 2017-06-28 PHASE4
NCT01896921 COMPLETED
HIV
University of Maryland, Baltimore
 2013-09 PHASE3
NCT02976259 COMPLETED
HIV Infection Primary
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
 2017-01 PHASE3
NCT03314064 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2016-12-08 PHASE4
NCT02551523 UNKNOWN
Monotherapy; Dolutegravir; Primary HIV Infection; Treatment Efficacy
University of Zurich
 2016-11 PHASE2
NCT02777229 COMPLETED
HIV-1 Infection
ANRS, Emerging Infectious Diseases
 2016-07 PHASE3
NCT02486133 COMPLETED
HIV-Infection
Technical University of Munich
 2015-07 PHASE3
NCT03441984 COMPLETED
HIV Infections
ViiV Healthcare
 2018-02-26 PHASE1
NCT02831764 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2016-07-18 PHASE3
NCT02831673 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2016-07-21 PHASE3
NCT03493568 TERMINATED
HIV-1-infection
IRCCS San Raffaele
 2017-02-06 PHASE3
NCT03199690 UNKNOWN
HIV-1-infection; Tuberculosis
St. Stephens Clinical Research
 2017-10 PHASE1
NCT03094507 COMPLETED
HIV
St Stephens Aids Trust
 2017-04-19 PHASE1
NCT02178592 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2015-01-23 PHASE3
NCT02098837 COMPLETED
HIV
St Stephens Aids Trust
 2014-04 PHASE4
NCT02069834 WITHDRAWN
HIV Infection; HAART-treated; Virologically Controlled
Nantes University Hospital
 2014-05 PHASE2; PHASE3
NCT03078556 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2017-03-27 PHASE1
NCT02227238 COMPLETED
HIV Infections
ViiV Healthcare
 2014-12-11 PHASE3
NCT02263326 COMPLETED
HIV Infection
Babafemi Taiwo
 2014-12 PHASE3
NCT02370979 UNKNOWN
HIV-1 Infection
University Hospital, Strasbourg, France
 2015-02 PHASE4
NCT02596334 TERMINATED
HIV
Centre Hospitalier Régional d'Orléans
 2015-12-23 PHASE3
NCT03095638 COMPLETED
HIV Infections
ViiV Healthcare
 2017-05-03 PHASE1
NCT02386098 TERMINATED
HIV Infections
ViiV Healthcare
 2015-07-08 PHASE2
NCT02401828 COMPLETED
Human Immunodeficiency Virus
Erasmus Medical Center
 2015-03 PHASE4
NCT02572947 COMPLETED
Human Immunodeficiency Virus; Dolutegravir; Monotherapy; Treatment Efficacy
Calmy Alexandra
 2016-06 PHASE2
NCT02607956 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-11 PHASE3
NCT02603120 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-11 PHASE3
NCT02607930 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-13 PHASE3
NCT02527096 COMPLETED
HIV-1 Infection
ANRS, Emerging Infectious Diseases
 2015-09-17 PHASE2
NCT02582684 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2015-12-08 PHASE2
NCT02509195 COMPLETED
HIV
St Stephens Aids Trust
 2015-08-04 PHASE4
NCT02566707 TERMINATED
HIV-1 Infection
Radboud University Medical Center
 2015-08 PHASE2
NCT02893488 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2016-09-01 PHASE1
NCT02513147 COMPLETED
HIV-1
Hospital Universitari Vall d'Hebron Research Institute
 2015-06 PHASE4
NCT02741557 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2016-05-11 PHASE1
NCT02404805 COMPLETED
HIV; Hepatitis C
University of Colorado, Denver
 2016-02
NCT01536873 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2012-06-14
NCT02478632 COMPLETED
HIV Infections
ViiV Healthcare
 2015-06-12 PHASE3
NCT02422797 COMPLETED
HIV Infections
ViiV Healthcare
 2015-04-21 PHASE3
NCT02500446 COMPLETED
HIV
University of Melbourne
 2015-09-28 PHASE4
NCT02429791 COMPLETED
HIV Infections
ViiV Healthcare
 2015-04-14 PHASE3
NCT02242799 COMPLETED
Malaria; HIV
University of Liverpool
 2015-06 PHASE1
NCT02542852 COMPLETED
HIV-1 Infection
Castagna Antonella
 2015-09 PHASE2
NCT02738931 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2016-05 PHASE1
NCT02499978 WITHDRAWN
HIV/AIDS
Stanford University
 2016-05 PHASE2; PHASE3
NCT02715479 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2016-04 PHASE1
NCT02351908 COMPLETED
HIV
St Stephens Aids Trust
 2015-03 PHASE4
NCT02211482 COMPLETED
HIV-1 Infection
Fundación Huésped
 2014-10 PHASE4
NCT02067767 COMPLETED
HIV-1 Infection
Nantes University Hospital
 2014-02 PHASE2
NCT02397694 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-03-23 PHASE2
NCT02211690 COMPLETED
Human Immunodeficiency Virus
Andrew Carr
 2014-08 PHASE4
NCT02539576 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2015-10 PHASE1
NCT01966822 COMPLETED
HIV-1 Infection
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2014-01 PHASE3
NCT01910402 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2013-08-22 PHASE3
NCT02373930 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2015-02 PHASE1
NCT02487706 COMPLETED
HIV
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2015-06 PHASE4
NCT02105987 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-04 PHASE3
NCT02285374 UNKNOWN
HIV
St Stephens Aids Trust
 2014-11 PHASE4
NCT02219217 COMPLETED
HIV
St Stephens Aids Trust
 2014-10 PHASE1
NCT02185300 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-07 PHASE1
NCT02082808 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-03 PHASE1
NCT02064374 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-02 PHASE1
NCT01967771 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2013-10 PHASE1
NCT01827540 COMPLETED
HIV-infection/AIDS
Tobira Therapeutics, Inc.
 2013-03 PHASE1
NCT01449929 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2011-10-31 PHASE3
NCT01762995 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2012-12 PHASE1
NCT01459315 COMPLETED
Healthy
University of North Carolina, Chapel Hill
 2011-11 PHASE1
NCT01568892 COMPLETED
HIV Infections
ViiV Healthcare
 2012-04-18 PHASE3
NCT01499199 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2012-01 PHASE3
NCT01404806 COMPLETED
Healthy Adult Females
University of North Carolina, Chapel Hill
 2011-08 PHASE1
NCT01622790 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2012-06 PHASE1
NCT01263015 COMPLETED
Infection, Human Immunodeficiency Virus I
ViiV Healthcare
 2011-02-01 PHASE3
NCT01563328 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2012-03-01 PHASE1
NCT01328041 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2011-05 PHASE3
NCT01353716 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2011-06 PHASE1
NCT01498861 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2011-12 PHASE1
NCT01227824 COMPLETED
Infection, Human Immunodeficiency Virus I
ViiV Healthcare
 2010-10-19 PHASE3
NCT01467518 COMPLETED
Infections, Human Immunodeficiency Virus and Hepatitis
ViiV Healthcare
 2011-12 PHASE1
NCT01467531 COMPLETED
Infections, Human Immunodeficiency Virus and Hepatitis
ViiV Healthcare
 2011-11 PHASE1
NCT01425099 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2011-09 PHASE1
NCT01382238 COMPLETED
Infections, Human Immunodeficiency Virus and Herpesviridae
ViiV Healthcare
 2011-06 PHASE1
NCT01366547 COMPLETED
Healthy Subjects; Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2011-06 PHASE1
NCT01332565 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2011-04 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-14)

Check the GSK1349572 (Dolutegravir) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dolutegravir is a two-metal-binding HIV integrase inhibitor that binds to the active site of the viral integrase enzyme, thereby blocking the essential strand-transfer step of retroviral integration into host cell DNA. By suppressing viral integration and subsequent viral replication, dolutegravir prevents systemic viral expansion, rendering it effective for the clinical management of human immunodeficiency virus (HIV) infection and related pediatric HIV or tuberculosis co-infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.