4 completed, 3 terminated, 2 recruiting, 2 unknown. 5 Phase 2, 3 Phase 3, 2 Phase 4, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Recruiting 2, Terminated 2, Unknown 1 |
| Phase 3 | 3 | Completed 2, Not yet recruiting 1 |
| Phase 4 | 2 | Completed 1, Unknown 1 |
| Phase 1 | 1 | Recruiting 1 |
Follow Dolutegravir (DTG): new trials by email Literature Review of Dolutegravir (DTG) trials Research Report on Dolutegravir (DTG)
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 |
| 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 |
| 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 |
| Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum Bictegravir (BIC), Tenofovir alafenamide (TAF), Long-acting injectable formulation of cabotegravir (CAB LA) - HIV, Tuberculosis | Terminated | National Institute of Allergy and Infectious Diseases (NIAID) | 205 | 2021-09-01 | 2026-08-26 | |
| Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals Dolutegravir (DTG), Isoniazid (INH), Rifapentine (RPT) - HIV Infection, LTBI | Phase 2 | Terminated | National Institute of Allergy and Infectious Diseases (NIAID) | 37 | 2021-02-27 | 2024-09-19 |
| 'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor Dolutegravir (DTG), Lamivudine (3TC), Rilpivirine (RPV) - HIV Infections | Completed | ViiV Healthcare | 774 | 2019-11-18 | 2025-01-22 | |
| Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept. Dolutegravir (DTG), Lamivudine (3TC) - HIV-1-infection | Phase 2 | Unknown | Instituto de Investigación Hospital Universitario La Paz | 41 | 2017-11-02 | 2020-07-07 |
| An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir Plus Lamivudine With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Subjects (Gemini 1) Dolutegravir (DTG), Lamivudine (3TC), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC) - Infection, Human Immunodeficiency Virus, HIV Infections | Phase 3 | Completed | ViiV Healthcare | 719 | 2016-07-21 | 2023-08-24 |
| 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) Dolutegravir (DTG), Lamivudine (3TC), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC) - Infection, Human Immunodeficiency Virus, HIV Infections | Phase 3 | Completed | ViiV Healthcare | 722 | 2016-07-18 | 2023-12-07 |
| Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND) Placebo for maraviroc (MVC), Placebo for dolutegravir (DTG), Dolutegravir (DTG) - HIV Infections | Phase 4 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 191 | 2016-04-21 | 2022-04-22 |
| Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults BMS-955176, Atazanavir (ATV), Ritonavir (RTV) - HIV Infections | Phase 2 | Terminated | ViiV Healthcare | 86 | 2015-07-08 | 2018-08-20 |
| Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Nevirapine (NVP), Lopinavir/Ritonavir (LPV/r) - HIV Infection | Phase 1 / Phase 2 | Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 1120 | 2015-01-23 | 2026-09-09 |
HIV Infections (8) · Acquired Immunodeficiency Syndrome (2) · Infections (2) · Anxiety Disorders (1) · Depression (1) · HTLV-I Infections (1) · Leukemia-Lymphoma, Adult T-Cell (1) · Neuritis (1) · Paraparesis, Tropical Spastic (1) · Sleep Initiation and Maintenance Disorders (1) · Suicide (1) · Tuberculosis (1)
National Institute of Allergy and Infectious Diseases (NIAID) (4) · ViiV Healthcare (4) · Carlos Brites (1) · Instituto Mexicano del Seguro Social (1) · Instituto de Investigación Hospital Universitario La Paz (1) · University College, London (1)
United States (7) · South Africa (6) · Thailand (5) · Argentina (4) · Brazil (4) · Puerto Rico (4) · Spain (4) · Australia (3) · Canada (3) · Mexico (3) · Russia (3) · Taiwan (3) · Belgium (2) · France (2) · Germany (2)
Anthony Podany, PharmD (1) · Carlos Brites, MD, PhD (1) · Ellen Chadwick, MD (1) · Jennifer Jao, MD (1) · Kevin Robertson, PhD (1) · Mark Mirochnick, MD (1)
PMID 34913844, PMID 32408111, PMID 36447613, PMID 38568956, PMID 39813286, PMID 40134635
2015 (1), 2016 (1), 2017 (1), UM1AI068616 (1), UM1AI068632 (1), UM1AI106716 (1)