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DTG/3TC

Phase 3

HIV | Small molecule | Infectious Disease |GSK plc|Last Updated: Jul 9, 2026

Target and mechanism

ModalitySmall molecule

Also known as DTG Tablet, DTG

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment205

FDA Designations

No designations recorded

Clinical trial landscape

DTG/3TC · 1 trial · 2 indications

Phase 3 1
NCT05911360A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAFHIV
COMPLETED205 Analytics
PHASE3COMPLETED
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
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Study Endpoints

Primary Endpoints

Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=)50 Copies/Millilitre (c/mL) at Week 48
At Week 48

Participants with HIV-1 RNA \>= 50 c/mL were evaluated. Virologic outcome was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the Week 48 Window. The analysis was done using the modified Snapshot algorithm.

Secondary Endpoints

Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 24
At Week 24
Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 96
At Week 96
Number of Participants With Plasma HIV-1 RNA Less Than (<) 50 c/mL at Week 24
At Week 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose combination (FDC)EXPERIMENTALParticipants living with HIV switched from Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) on Day 1 and received once daily dose of DTG/3TC FDC for 96 weeks. At Week 96, all participants switched to locally available DTG/3TC FDC or local standard of care (SOC) Antiretroviral Therapy (ART).

Interventions

NameTypeDescription
DTG/3TCDRUGDTG/3TC FDC was administered once daily.
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites56

Inclusion Criteria: * Participants living with HIV-1 and had documented plasma HIV-1 RNA \<50 c/mL within 3 months prior to Screening. * Participants had been on uninterrupted ART for ≥1 year (except for brief periods \[less than 30 days\] where all ART had been stopped due to tolerability and/or s...

Countries:United StatesAustriaBelgiumCanadaFranceGermanyItalyMexicoNetherlandsPortugalSpainUnited Kingdom
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Recent Changes (Last 90 Days)

MEDIUMAug 9, 2026NCT05911360TRIAL_REMOVED: changed
MEDIUMAug 9, 2026NCT05911360TRIAL_REMOVED: changed
MEDIUMAug 9, 2026NCT05911360TRIAL_REMOVED: changed
MEDIUMJun 14, 2026NCT05911360TRIAL_REMOVED: changed
MEDIUMJun 14, 2026NCT05911360TRIAL_REMOVED: changed
MEDIUMJun 14, 2026NCT05911360TRIAL_REMOVED: changed

Frequently asked questions about DTG/3TC

What is DTG used for in HIV?

DTG is an investigational small molecule in Phase 3 clinical development for the treatment of HIV infections, including human immunodeficiency virus type 1. It is being studied in adults and adolescents as part of combination antiretroviral regimens, including switch studies for virologically suppressed patients and as initial therapy in treatment-naive individuals.

What does DTG target?

DTG is a small molecule antiretroviral agent. Its specific molecular target is not disclosed in the available clinical trial information. The drug is being evaluated in Phase 3 studies for HIV treatment, often in combination with other antiretrovirals such as rilpivirine or lamivudine.

Who makes DTG?

DTG is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety in treating HIV infections across multiple countries.

What phase is DTG in?

DTG is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trials are completed, with no active trials currently ongoing, and the drug is being studied for the treatment of HIV infections.

What clinical trials is DTG in?

DTG has been studied in several Phase 3 clinical trials, including NCT02429791 (SWORD-1), a switch study to dolutegravir plus rilpivirine in virologically suppressed adults; NCT03446573 (TANGO), a switch study to dolutegravir plus lamivudine; NCT03682848, a study in treatment-naive HIV-1 infected adolescents; and NCT05917509, a study comparing oral once-daily and long-acting injectable regimens in treatment-naive adults.

Is DTG the same as DTG Tablet?

Yes, DTG is also known as DTG Tablet. The drug is referred to by both names in clinical research contexts. It is being developed as an oral small molecule for the treatment of HIV infections and is currently in Phase 3 clinical trials.