DOLUTEGRAVIR

Pre-LaunchSM

dolutegravir

NDAORALFILMPriority Review
Lifecycle
Pre-Launch
Clinical Trials
20

Mechanism of Action

fixed-dose combination of the HIV‑1 antiretroviral agents abacavir, dolutegravir, and lamivudine [see Microbiology ()].

Indications (2)

HIV-1 infection in adultsweighing at least 6 kg

Clinical Trials (5)

NCT06497465Phase 3Recruiting

Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment

Started Sep 2025
150 enrolled
TuberculosisHIV
NCT06967753Phase 4Recruiting

Switch to Dolutegravir Plus Lamivudine Dual-Therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)

Started Jul 2025
50 enrolled
HIVHIV-1
NCT06580873Phase 4Not Yet Recruiting

Evaluation of Switch to Dolutegravir/Lamivudine (DTG/3TC) From Current Suppressive Antiretroviral Therapy in People Living With HIV (PLWH) Receiving Opioid Agonist Therapy (OAT)

Started Sep 2024
40 enrolled
HIV-1-infectionOpioid Use Disorder
NCT05630872Phase 2Completed

Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis

Started Feb 2024
30 enrolled
HIV-associated Tuberculosis
NCT04453436N/AActive Not Recruiting

HIV Drug Resistance Among Individuals Failing Tenofovir/Lamivudine and Dolutegravir First Line Regimen in Brazil

Started Sep 2023
2,500 enrolled
HIVDrugResistance
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers