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Home › Medications › dolutegravir

dolutegravir

6 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials of dolutegravir

15 trials tracked of dolutegravir: 6 in phase 3 or 4 and 3 with published results. The most-cited published study has 158 citations.

15Trials tracked
6Phase 3 & 4
0Recruiting
3With published results
Phase distribution
Phase 3 6 Phase 2 2 Phase 1 4 Other / NA 3
  1. Phase 3 Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants Completed · 158 cited
  2. Phase 3 ODYSSEY (PENTA 20) Completed · 118 cited
  3. Phase 3 Dolutegravir Antiretroviral Strategy to Promote Improvement and Reduce Drug Exposure Completed · 85 cited
  4. Phase 3 A Study to Assess Dolutegravir in HIV-infected Subjects With Treatment Failure on an Integrase Inhibitor Containing Regimen. Completed
  5. Phase 3 A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial) Completed
  6. Phase 3 A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects Completed
Show 9 more trials
  1. Phase 2 Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients Completed
  2. Phase 2 Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary Tuberculosis Completed
  3. Phase 1 The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers Completed
  4. Phase 1 Evaluation of Safety, Tolerability, Pharmacokinetics, Drug-Drug and Food Interactions of Single and Multiple Doses of S-648414 in Healthy Adults Completed
  5. Phase 1 HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) Completed
  6. Phase 1 Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine Completed
  7. N/A Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy Completed
  8. N/A Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults Completed
  9. N/A Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers Completed

Showing the 15 most-cited and recently-updated of 15 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Preplanned subanalysis shows comparable viral suppression rates for two dolutegravir-based regimens in antiretroviral-naive people with HIV at week 48
Infectious Disease RCT
Preplanned subanalysis shows comparable viral suppression rates for two dolutegravir-based regimens in antiretroviral-naive people with HIV at week 48 New HIV drug combo shows similar virus control to standard care in people with resistance markers
A preplanned subanalysis of a phase IV study compared dolutegravir plus lamivudine against dolutegravir plus tenofovir disoproxil fumarate w…
A specific HIV drug mix controlled the virus just as well as a standard mix in people with certain resistance markers, offering a potential …
Jun 1, 2026
Meta-analysis of dolutegravir-based ART and risk-stratified HIV care in Uganda
Primary Care & Family Medicine Meta-analysis
Meta-analysis of dolutegravir-based ART and risk-stratified HIV care in Uganda HIV Treatment Works Better Now, But One Problem Remains
This meta-analysis and cohort review examined viral non-suppression rates among people with HIV in Uganda receiving dolutegravir-based ART. …
New HIV drugs are highly effective, yet thousands of patients in Uganda still have uncontrolled virus, and a fresh approach using routine da…
Frontiers May 4, 2026
INSTI switching linked to higher metabolic risk in people with HIV
Diabetes & Endocrinology RCT
INSTI switching linked to higher metabolic risk in people with HIV Switching HIV meds raises diabetes risk but not heart attack danger
A global cohort study found that switching to integrase inhibitors increased risks for obesity, diabetes, and hypertension, but not MACE, ov…
Switching HIV medication to a newer class may raise the risk of diabetes and weight gain, but it does not appear to increase the risk of hea…
May 2, 2026
HIV-1 resistance patterns vary by prior regimen and geographic region in this substudy
Infectious Disease RCT
HIV-1 resistance patterns vary by prior regimen and geographic region in this substudy HIV drug resistance patterns vary by region and prior treatment history
This substudy examined HIV-1 drug resistance mutations in people failing first-line therapy across 14 countries.
HIV drug resistance varies by region and prior treatment. Subtype C dominates, but resistance to common drugs is high. This matters for choo…
May 1, 2026
Target trial emulation in Johannesburg shows dolutegravir associated with greater weight and blood pressure increases versus efavirenz
Infectious Disease RCT
Target trial emulation in Johannesburg shows dolutegravir associated with greater weight and blood pressure increases versus efavirenz New HIV drug linked to higher weight and blood pressure in South Africa
This target trial emulation compared dolutegravir to efavirenz in 2930 treatment-naive individuals in Johannesburg, South Africa.
People starting a new HIV drug in South Africa gained more weight and saw higher blood pressure than those on an older treatment.
May 1, 2026
Switching from EFV/TDF/3TC to B/F/TAF or DTG/3TC in virologically suppressed PLWH shows no significant between-group metabolic differences over 24 months
Drug Pipeline Cohort
Switching from EFV/TDF/3TC to B/F/TAF or DTG/3TC in virologically suppressed PLWH shows no significant between-group metabolic differences over 24 months Switching HIV drugs showed similar metabolic changes over two years in this real-world study
This retrospective real-world study evaluated 326 virologically suppressed persons with HIV (PLWH) switching from efavirenz/tenofovir disopr…
Switching HIV drugs caused similar weight gain and metabolic shifts over two years, meaning lifestyle factors matter more than the specific …
Frontiers Apr 18, 2026