Dolutegravir 50 mg

DRUG17 trials

Sponsors

ViiV Healthcare, Fundação Bahiana de Infectologia, University of North Carolina, Chapel Hill, ANRS, Emerging Infectious Diseases, Blueclinical, Ltd.

Conditions

Abnormality of Adipose TissueAcute HIV InfectionAntiviral Drug Adverse ReactionBody Fat DisorderBody Weight ChangesCardiovascular AbnormalitiesHIVHIV II Infection

Phase 1

Dolutegravir Renal Impairment Study

CompletedNCT01353716

ViiV HealthcareInfection, Human Immunodeficiency Virus

Start: 2011-06-30End: 2012-04-30Updated: 2012-04-30

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

CompletedNCT01366547

ViiV HealthcareHealthy Subjects, Infection, Human Immunodeficiency Virus

Start: 2011-06-30End: 2011-07-31Updated: 2011-08-08

Evaluation of the Bioequivalence of a Combined Formulated Tablet

CompletedNCT01622790

ViiV HealthcareInfection, Human Immunodeficiency Virus

Start: 2012-06-30End: 2012-08-31Updated: 2012-10-15

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

CompletedNCT01762995

ViiV HealthcareInfection, Human Immunodeficiency Virus

Start: 2012-12-31End: 2013-03-31Updated: 2013-04-22

Phase 2

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

CompletedNCT01837277

Fundação Bahiana de InfectologiaSeverely Immunocompromised HIV Patients

Start: 2017-12-15End: 2021-09-30Updated: 2023-12-14

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

CompletedNCT03224338

Blueclinical, Ltd.HIV II Infection

Start: 2017-04-05End: 2019-07-02Updated: 2019-09-03

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

CompletedNCT03851588

University of Cape TownHIV Infections, Tuberculosis

Start: 2019-12-19End: 2022-06-28Updated: 2024-07-18

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

CompletedNCT03991013

University of Cape TownHIV Infections

Start: 2019-08-08End: 2022-10-27Updated: 2024-10-01

Effect of Dolutegravir Intensification on HIV-1 Reservoirs

CompletedNCT05351684

University of LiegeHIV-1-infection

Start: 2019-01-01End: 2022-12-13Updated: 2022-12-15

Phase 3

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

CompletedNCT02777229

ANRS, Emerging Infectious DiseasesHIV-1 Infection

Start: 2016-07-31End: 2021-07-31Updated: 2021-08-31

Phase 4

Phase 4 Study of Dolutegravir (DTG) in Russian Federation

CompletedNCT03314064

ViiV HealthcareHIV Infections, Infection, Human Immunodeficiency Virus

Start: 2016-12-08End: 2018-10-01Updated: 2019-02-04

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

CompletedNCT03360682

Fundacion Clinic per a la Recerca BiomédicaHIV-1-infection, Solid Organ Transplant

Start: 2018-04-13End: 2020-05-21Updated: 2025-09-30

Contribution of Dolutegravir to Obesity and Cardiovascular Disease

CompletedNCT04340388

Augusta UniversityAbnormality of Adipose Tissue, Antiviral Drug Adverse Reaction, Body Fat Disorder +5

Start: 2020-09-17End: 2023-02-25Updated: 2023-07-27

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

RecruitingNCT04746547

University of KwaZuluHiv, Tuberculosis

Start: 2021-08-19End: 2025-07-31Target: 20Updated: 2024-02-01

Unknown Phase

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

CompletedNCT02384395

University of North Carolina, Chapel HillAcute HIV Infection, HIV

Start: 2015-09-30End: 2021-09-17Updated: 2021-11-22

Rapid HIV Treatment Initiation, Access and Engagement in Care

CompletedNCT03512964

Johns Hopkins UniversityHuman Immunodeficiency Virus

Start: 2016-11-29End: 2020-09-13Updated: 2022-10-27

REal-Life Cohort With DOlutegravir + LAmivudina

CompletedNCT04638686

Instituto de Investigación Sanitaria de la Fundación Jiménez DíazHIV-1-infection

Start: 2020-06-15End: 2022-03-31Updated: 2023-11-14

Related Papers

Doubling dolutegravir dosage reduces the viral reservoir in ART-treated people with HIV.

2026-01-23

Doubling dolutegravir dosage reduces the viral reservoir in ART-treated people with HIV

eLife2026-01-23

Dolutegravir-based Antiretroviral Therapy in People With HIV With Solid Organ Transplantation: A Single-arm Pilot Clinical Trial (DTG-SOT)

Open Forum Infectious Diseases2025-03-122 citations

Pharmacokinetics and safety of dolutegravir in children receiving rifampicin tuberculosis treatment in South Africa (ORCHID): a prospective cohort study.

2025-02-262 citations

Durability of the Efficacy and Safety of Dolutegravir-Based and Low-Dose Efavirenz–Based Regimens for the Initial Treatment of Human Immunodeficiency Virus Type 1 Infection in Cameroon: Week 192 Data of the NAMSAL-ANRS-12313 Study

Open Forum Infectious Diseases2023-11-165 citations

Safety and Efficacy of Triple Therapy With Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors in Treatment-Naive Human Immunodeficiency Virus Type 2 Patients: Results From a 48-Week Phase 2 Study.

2023-09-015 citations

Improvements in Patient-Reported Outcomes Following Initiation of Dolutegravir-Based or Low-Dose Efavirenz-Based First-Line Antiretroviral Therapy: A Four-Year Longitudinal Analysis in Cameroon (NAMSAL ANRS 12313 Trial)

JAIDS Journal of Acquired Immune Deficiency Syndromes2023-08-293 citations

Standard-dose versus double-dose dolutegravir in HIV-associated tuberculosis in South Africa (RADIANT-TB): a phase 2, non-comparative, randomised controlled trial.

2023-05-2230 citations

Initial Supplementary Dose of Dolutegravir in Second-Line Antiretroviral Therapy: A Noncomparative, Double-Blind, Randomized Placebo-Controlled Trial

Clinical Infectious Diseases2023-01-167 citations

Dolutegravir twice-daily dosing in children with HIV-associated tuberculosis: a pharmacokinetic and safety study within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial.

2022-07-1920 citations

AntiRetroviral Therapy In Second-line: investigating Tenofovir-lamivudine-dolutegravir (ARTIST): protocol for a randomised controlled trial.

2021-02-175 citations

Standard versus double dose dolutegravir in patients with HIV-associated tuberculosis: a phase 2 non-comparative randomised controlled (RADIANT-TB) trial.

2021-01-118 citations

Cost-Utility Analysis of a Dolutegravir-Based Versus Low-Dose Efavirenz-Based Regimen for the Initial Treatment of HIV-Infected Patients in Cameroon (NAMSAL ANRS 12313 Trial)

PharmacoEconomics2020-12-2315 citations

Dolutegravir-based and low-dose efavirenz-based regimen for the initial treatment of HIV-1 infection (NAMSAL): week 96 results from a two-group, multicentre, randomised, open label, phase 3 non-inferiority trial in Cameroon.

2020-10-01120 citations

Dolutegravir-Based or Low-Dose Efavirenz–Based Regimen for the Treatment of HIV-1

New England Journal of Medicine2019-07-24317 citations

Bioequivalence of a dolutegravir, abacavir, and lamivudine fixed-dose combination tablet and the effect of food.

2014-08-0122 citations