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Dolutegravir

Phase 3

HIV | Small molecule | Infectious Disease |GSK plc|Last Updated: Dec 5, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment473
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05979311A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral TherapyPHASE3 ACTIVE NOT_RECRUITING 473 — — Feb 9, 2024Feb 23, 2027Dec 5, 202564 Argentina, Belgium +15
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Study Endpoints
Primary Endpoints
Percentage of participants with plasma HIV- Ribonucleic acid (RNA) less than (<)50 copies per milliliter (c/mL) as per snapshot algorithm at Week 48
Week 48
Secondary Endpoints
Percentage of participants with plasma HIV-1 RNA <50 c/mL as per snapshot algorithm at Weeks 24 and 96
Weeks 24 and 96
Percentage of participants with HIV-RNA greater than or equal to (>=)50 c/mL as per snapshot algorithm at Weeks 24, 48, and 96
Weeks 24, 48 and 96
Change from Baseline in HIV-1 RNA at Weeks 24, 48 and 96
Baseline (Day 1) and Weeks 24, 48 and 96
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DTG/3TCEXPERIMENTALParticipants will receive FDC of DTG/3TC once daily until Week 96.
BIC/FTC/TAFACTIVE_COMPARATORParticipants will receive BIC/FTC/TAF once daily until Week 96.
Interventions
NameTypeDescription
DolutegravirDRUGDolutegravir will be administered once daily.
LamivudineDRUGLamivudine will be administered once daily.
BictegravirDRUGBictegravir will be administered once daily.
EmtricitabineDRUGEmtricitabine will be administered once daily.
Tenofovir alafenamideDRUGTenofovir alafenamide will be administered once daily.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion Criteria: * Participants with age \>=18 years (or older, if required by local regulations) at the time of obtaining informed consent. * An individual participant is eligible to participate if they are not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test a...

Countries:ArgentinaBelgiumDenmarkFranceGermanyGreeceIrelandIsraelItalyJapanMexicoPolandPortugalSpainSwedenSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05979311primaryCompletionDate: changed
LOWMay 24, 2026NCT05979311studyFirstPostDate: changed