Dolutegravir (DTG)

DRUG11 trials

Conditions

AnxietyHIVHIV InfectionHIV InfectionsHIV-1-infectionHTLV I Associated MyelopathiesHTLV I Associated T Cell Leukemia LymphomaHTLV-1 Infection

Phase 1

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

RecruitingNCT02140255

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infection

Start: 2015-01-23End: 2031-12-31Target: 1120Updated: 2026-04-28

Phase 2

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

TerminatedNCT02386098

ViiV HealthcareHIV Infections

Start: 2015-07-08End: 2017-06-07Updated: 2018-08-20

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

NCT03539224

Instituto de Investigación Hospital Universitario La PazHIV-1-infection

Start: 2017-11-02End: 2021-07-31Updated: 2020-07-07

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

TerminatedNCT04272242

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infection, LTBI

Start: 2021-02-27End: 2021-12-27Updated: 2024-09-19

Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection

Not yet recruitingNCT07555431

Carlos BritesHTLV-1 Infection, HTLV I Associated Myelopathies, HTLV I Associated T Cell Leukemia Lymphoma +1

Start: 2026-04-01End: 2028-06-01Target: 146Updated: 2026-05-04

Phase 3

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)

CompletedNCT02831764

ViiV HealthcareHIV Infections, Infection, Human Immunodeficiency Virus

Start: 2016-07-18End: 2022-06-29Updated: 2023-12-07

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

CompletedNCT02831673

ViiV HealthcareHIV Infections, Infection, Human Immunodeficiency Virus

Start: 2016-07-21End: 2022-08-15Updated: 2023-08-24

Phase 4

Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)

CompletedNCT02519777

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections

Start: 2016-04-21End: 2021-01-05Updated: 2022-04-22

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

Not yet recruitingNCT06787976

Instituto Mexicano del Seguro SocialAnxiety, HIV, Insomnia

Start: 2025-06-19End: 2026-01-25Target: 140Updated: 2025-06-26

Unknown Phase

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

CompletedNCT04019873

ViiV HealthcareHIV Infections

Start: 2019-11-18End: 2023-12-05Updated: 2025-01-22

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

CompletedNCT04518228

National Institute of Allergy and Infectious Diseases (NIAID)HIV Infections, Tuberculosis

Start: 2021-09-01End: 2025-07-10Updated: 2025-11-12

2025-09-25

Efficacy and Safety Outcomes in Adults Initiating Dolutegravir/Lamivudine With High Viral Load in the GEMINI-1/-2 and STAT Trials

Open Forum Infectious Diseases2025-02-282 citations

Twice-Daily Dolutegravir–Based Antiretroviral Therapy With 1 Month of Daily Rifapentine and Isoniazid for Tuberculosis Prevention

Clinical Infectious Diseases2024-04-035 citations

HIV-1 reservoir size after neonatal antiretroviral therapy and the potential to evaluate antiretroviral-therapy-free remission (IMPAACT P1115): a phase 1/2 proof-of-concept study.

2023-12-0410 citations

Long-term Evaluation of Residual Viremia in a Clinical Trial of Dolutegravir Plus Lamivudine as Maintenance Treatment for Participants With and Without Prior Lamivudine Resistance

Open Forum Infectious Diseases2022-11-0111 citations

Infants Receiving Very Early Antiretroviral Therapy Have High CD4 Counts in the First Year of Life

Clinical Infectious Diseases2022-08-295 citations

Impact of treatment adherence on efficacy of dolutegravir plus lamivudine and dolutegravir plus tenofovir disoproxil fumarate/emtricitabine: pooled analysis of the GEMINI-1 and GEMINI-2 clinical studies

HIV Research & Clinical Practice2021-12-1611 citations

Pharmacokinetics and safety of early nevirapine-based antiretroviral therapy for neonates at high risk for perinatal HIV infection: a phase 1/2 proof of concept study.

2020-11-2312 citations

1024. Impact of Treatment Adherence on Efficacy of DTG/3TC and DTG + TDF/FTC: Pooled Analysis of the GEMINI 1 and 2 Clinical Trials

Open Forum Infectious Diseases2020-10-011 citations

Dolutegravir plus lamivudine for maintenance of HIV viral suppression in adults with and without historical resistance to lamivudine: 48-week results of a non-randomized, pilot clinical trial (ART-PRO).

2020-05-1126 citations

2842. Durable Efficacy of Two-Drug Regimen (2DR) of Dolutegravir (DTG) plus Lamivudine (3TC) in Antiretroviral Treatment-Naïve Adults with HIV-1 Infection at 96 Weeks: Subgroup Analyses in the GEMINI Studies

Open Forum Infectious Diseases2019-10-01

Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials.

2018-11-09272 citations

The Mission is Remission

The Pediatric Infectious Disease Journal2018-10-222 citations

Dolutegravir–lamivudine as initial therapy in HIV‐1 infected, ARV‐naive patients, 48‐week results of the PADDLE (Pilot Antiretroviral Design with Dolutegravir LamivudinE) study

Journal of the International AIDS Society2017-01-01101 citations