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CompletedNCT05911360EYEWITNESSUpdated Jul 9, 2026Results posted

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

A Phase 3 interventional study of DTG/3TC in HIV and HIV Infections, sponsored by ViiV Healthcare. Completed at 56 sites in 12 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by ViiV Healthcare · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
205
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

The study aims at evaluating the maintenance of virologic suppression of dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC) at Week 48 post-switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in participants living with Human Immunodeficiency Virus Type 1 (HIV-1) who are of at least 50 years of age and above.

02

Conditions studied

  • HIV
  • HIV Infections

Keywords

  • Human Immunodeficiency Virus (HIV)-1
  • Dolutegravir
  • Lamivudine
  • Bictegravir
  • Emtricitabine
  • Tenofovir alafenamide
  • Dovato
  • Biktarvy
  • Switch study
  • ≥50 years
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 205 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 safety concerns).
  • Participants had been on uninterrupted BIC/FTC/TAF for at least 6 months prior to Screening.
  • Participants had plasma HIV-1 RNA \<50 c/mL at Screening.
  • Participants had no known prior regimen switches due to documented virologic failure (defined as a confirmed plasma HIV-1 RNA ≥200 c/mL).
  • Participants with unknown full treatment/clinical history beyond 5 years prior to Screening may have been eligible upon discussion and agreement with the medical monitor.

Exclusion criteria

Exclusion Criteria:

  • Women participants were pregnant or breastfeeding or planned to become pregnant or breastfeed during the study.
  • Participants had any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease, EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/cubic millimetre (mm\^3) were not exclusionary.
  • Participants had signs and symptoms which, in the opinion of the investigator, were suggestive of active severe acute respiratory syndrome-related coronavirus (SARS-CoV-2) infection within 14 days prior to enrolment.
  • Participants had severe hepatic impairment (Class C) as determined by Child-Pugh classification.

  • Evidence of hepatitis B virus (HBV) infection was based on the results of testing at Screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows:

    1. Participants positive for HBsAg were excluded;
    2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, were excluded;
    3. Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) were immune to HBV and were not excluded.
  • Participants had unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
  • Participants had a history of liver cirrhosis with or without hepatitis viral co-infection.
  • Participants had untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who were at least 7 days post completed treatment were eligible.
  • Participants had a history or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicated their participation.
  • Participants had ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
  • Participants who, in the investigator's judgment, posed a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation was considered when evaluating for suicide risk.
  • Participants had any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major Integrase strand transfer inhibitor (INSTI) resistance associated mutation in any available prior resistance genotype assay test result. All available historical resistance reports with HIV-1 reverse transcriptase or integrase genotypic data were provided to ViiV after screening and before enrollment for review by ViiV Virology.
  • Participants had any verified Grade 4 laboratory abnormality with the exception of Grade 4 lipid abnormalities.

Alanine aminotransferase (ALT) was ≥5 times the upper limit of normal (ULN) or ALT was ≥3×ULN and bilirubin was ≥1.5×ULN (>35% direct bilirubin).

- Participants had estimated creatine clearance \<30 mL/min per 1.73 square meter (m\^2) using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKD-EPIcr_R) method.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
205 participants (actual)

Study arms

  • Experimental
    Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose combination (FDC)

    Participants 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).

    Drug: DTG/3TC

Interventions

  • DrugDTG/3TC

    DTG/3TC FDC was administered once daily.

06

What researchers measure

Primary outcomes

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

    Time frame: At Week 48

Secondary outcomes

  1. Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 24

    The number of participants with plasma HIV-1 RNA \>/=50 c/mL at Week 24 was analyzed using the Snapshot Algorithm.

    Time frame: At Week 24

  2. Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 96

    Data not available at the time of posting, will be updated at the final results disclosure stage.

    Time frame: At Week 96

  3. Number of Participants With Plasma HIV-1 RNA Less Than (<) 50 c/mL at Week 24

    The number of participants with plasma HIV-1 RNA \<50 c/mL at Week 24 was analyzed using the Snapshot Algorithm.

    Time frame: At Week 24

  4. Number of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 48

    The number of participants with plasma HIV-1 RNA \< 50 c/mL at Week 48 was analyzed using the modified Snapshot Algorithm.

    Time frame: At Week 48

  5. Number of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 96

    Data not available at the time of posting, will be updated at the final results disclosure stage.

    Time frame: At Week 96

  6. Absolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at Week 24

    Time frame: At Week 24

  7. Absolute Values for CD4+ Cells Count at Week 48

    Time frame: At Week 48

  8. Absolute Values for CD4+ Cells Count at Week 96

    Data not available at the time of posting, will be updated at the final results disclosure stage.

    Time frame: At Week 96

  9. Absolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at Week 24

    The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

    Time frame: At Week 24

  10. Absolute Values for CD4:CD8 Ratio at Week 48

    The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

    Time frame: At Week 48

  11. Absolute Values for CD4:CD8 Ratio at Week 96

    Data not available at the time of posting, will be updated at the final results disclosure stage.

    Time frame: At Week 96

  12. Change From Baseline in CD4+ Cells Count at Week 24

    Time frame: At Week 24 compared to Baseline

  13. Change From Baseline in CD4+ Cells Count at Week 48

    Time frame: At Week 48 compared to Baseline

  14. Change From Baseline in CD4+ Cells Count at Week 96

    Data not available at the time of posting, will be updated at the final results disclosure stage.

    Time frame: At Week 96 compared to baseline

  15. Change From Baseline in CD4:CD8 Ratio at Week 24

    The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

    Time frame: At Week 24 compared to Baseline

  16. Change From Baseline in CD4:CD8 Ratio at Week 48

    The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

    Time frame: At Week 48 compared to Baseline

  17. Change From Baseline in CD4:CD8 Ratio at Week 96

    Data not available at the time of posting, will be updated at the final results disclosure stage.

    Time frame: At Week 96 compared to baseline

  18. Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 24

    Occurrence of disease progression was evaluated through HIV-associated conditions and incidence of disease progression to United States Centers for Disease Control and Prevention (CDC) stage 3 or death.

    Time frame: Up to Week 24

  19. Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 48

    Time frame: Up to Week 48

  20. Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 96

    Time frame: Week 96

  21. Number of Participants With Viral Resistance After Meeting Confirmed Virologic Withdrawal (CVW) Criterion

    Confirmed virologic withdrawal criteria is defined as two consecutive assessments with HIV-1 RNA greater than or equal to (\>=)200 c/mL after Day 1 visit.

    Time frame: Up to Week 48

  22. Number of Participants With Viral Resistance After Meeting CVW Criterion

    Data not available at the time of posting, will be updated at the final results disclosure stage.

    Time frame: From Week 48 to Week 96

  23. Number of Participants With Treatment Related Non-serious Adverse Events (AEs)

    A treatment related non-serious AE is defined as any untoward medical occurrence in a clinical study participant considered related to the study treatment. Any = occurrence of the event regardless of intensity grade

    Time frame: Up to Week 48

  24. Number of Participants With Treatment Related Non-serious AEs

    Data not available at the time of posting, will be updated at the final results disclosure stage.

    Time frame: From Week 48 to Week 96

  25. Number of Participants With Any Serious Adverse Events (SAEs)

    An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.

    Time frame: Up to Week 48

  26. Number of Participants With SAEs

    Data not available at the time of posting, will be updated at the final results disclosure stage.

    Time frame: From Week 48 to Week 96

  27. Number of Participants With AEs Leading to Treatment Discontinuation

    Time frame: Up to Week 48

  28. Number of Participants With AEs Leading to Treatment Discontinuation

    Data not available at the time of posting, will be updated at the final results disclosure stage.

    Time frame: From Week 48 to Week 96

07

Results

Posted May 14, 2026

Participant flow

Participant flow — Overall Study
MilestoneParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Started205
Completed175
Not completed30
Withdrew: Physician decision2
Withdrew: Withdrawal by subject7
Withdrew: Adverse event5
Withdrew: Death1
Withdrew: Participant reached protocol defined stopping criteria15

Outcome measures

PrimaryNumber of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=)50 Copies/Millilitre (c/mL) 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.

Time frame:
At Week 48
Reported as:
Count of participants · Participants
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=)50 Copies/Millilitre (c/mL) at Week 48
ParticipantsParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=)50 Copies/Millilitre (c/mL) at Week 482
SecondaryNumber of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 24

The number of participants with plasma HIV-1 RNA \>/=50 c/mL at Week 24 was analyzed using the Snapshot Algorithm.

Time frame:
At Week 24
Reported as:
Count of participants · Participants
Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 24
ParticipantsParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Number of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 2414
SecondaryNumber of Participants With Plasma HIV-1 RNA >= 50 c/mL at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame:
At Week 96

Results for this outcome have not been posted.

SecondaryNumber of Participants With Plasma HIV-1 RNA Less Than (<) 50 c/mL at Week 24

The number of participants with plasma HIV-1 RNA \<50 c/mL at Week 24 was analyzed using the Snapshot Algorithm.

Time frame:
At Week 24
Reported as:
Count of participants · Participants
Number of Participants With Plasma HIV-1 RNA Less Than (<) 50 c/mL at Week 24
ParticipantsParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Participants with Plasma HIV-1 RNA < 50 c/mL183
Participants with no virologic data8
SecondaryNumber of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 48

The number of participants with plasma HIV-1 RNA \< 50 c/mL at Week 48 was analyzed using the modified Snapshot Algorithm.

Time frame:
At Week 48
Reported as:
Count of participants · Participants
Number of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 48
ParticipantsParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Participants with Plasma HIV-1 RNA < 50 c/mL177
Participants with no virologic data26
SecondaryNumber of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame:
At Week 96

Results for this outcome have not been posted.

SecondaryAbsolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at Week 24
Time frame:
At Week 24
Reported as:
Mean · cells per cubic millimeter (cells/mm^3)
Absolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at Week 24
cells per cubic millimeter (cells/mm^3)Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Absolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at Week 24724.8 ± 322.69
SecondaryAbsolute Values for CD4+ Cells Count at Week 48
Time frame:
At Week 48
Reported as:
Mean · cells/mm^3
Absolute Values for CD4+ Cells Count at Week 48
cells/mm^3Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Absolute Values for CD4+ Cells Count at Week 48723.6 ± 334.76
SecondaryAbsolute Values for CD4+ Cells Count at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame:
At Week 96

Results for this outcome have not been posted.

SecondaryAbsolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at Week 24

The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

Time frame:
At Week 24
Reported as:
Mean · Ratio
Absolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at Week 24
RatioParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Absolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at Week 241.127 ± 0.5861
SecondaryAbsolute Values for CD4:CD8 Ratio at Week 48

The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

Time frame:
At Week 48
Reported as:
Mean · Ratio
Absolute Values for CD4:CD8 Ratio at Week 48
RatioParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Absolute Values for CD4:CD8 Ratio at Week 481.210 ± 0.6203
SecondaryAbsolute Values for CD4:CD8 Ratio at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame:
At Week 96

Results for this outcome have not been posted.

SecondaryChange From Baseline in CD4+ Cells Count at Week 24
Time frame:
At Week 24 compared to Baseline
Reported as:
Mean · cells/mm^3
Change From Baseline in CD4+ Cells Count at Week 24
cells/mm^3Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Baseline733.6 ± 313.32
Week 24-8.9 ± 162.16
SecondaryChange From Baseline in CD4+ Cells Count at Week 48
Time frame:
At Week 48 compared to Baseline
Reported as:
Mean · cells/mm^3
Change From Baseline in CD4+ Cells Count at Week 48
cells/mm^3Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Baseline733.6 ± 313.32
Week 48-16.8 ± 190.56
SecondaryChange From Baseline in CD4+ Cells Count at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame:
At Week 96 compared to baseline

Results for this outcome have not been posted.

SecondaryChange From Baseline in CD4:CD8 Ratio at Week 24

The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

Time frame:
At Week 24 compared to Baseline
Reported as:
Mean · Ratio
Change From Baseline in CD4:CD8 Ratio at Week 24
RatioParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Baseline1.167 ± 0.6125
Week 24-0.027 ± 0.2325
SecondaryChange From Baseline in CD4:CD8 Ratio at Week 48

The CD4/CD8 ratio is defined as a numerical representation of the proportion of CD4+ T cells to CD8+ T cells in the blood.

Time frame:
At Week 48 compared to Baseline
Reported as:
Mean · Ratio
Change From Baseline in CD4:CD8 Ratio at Week 48
RatioParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Baseline1.167 ± 0.6125
Week 480.030 ± 0.2065
SecondaryChange From Baseline in CD4:CD8 Ratio at Week 96

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame:
At Week 96 compared to baseline

Results for this outcome have not been posted.

SecondaryNumber of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 24

Occurrence of disease progression was evaluated through HIV-associated conditions and incidence of disease progression to United States Centers for Disease Control and Prevention (CDC) stage 3 or death.

Time frame:
Up to Week 24
Reported as:
Count of participants · Participants
Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 24
ParticipantsParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 244
SecondaryNumber of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 48
Time frame:
Up to Week 48
Reported as:
Count of participants · Participants
Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 48
ParticipantsParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Number of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 486
SecondaryNumber of Participants With Disease Progression (HIV-associated Conditions, AIDS, and Death) Through Week 96
Time frame:
Week 96

Results for this outcome have not been posted.

SecondaryNumber of Participants With Viral Resistance After Meeting Confirmed Virologic Withdrawal (CVW) Criterion

Confirmed virologic withdrawal criteria is defined as two consecutive assessments with HIV-1 RNA greater than or equal to (\>=)200 c/mL after Day 1 visit.

Time frame:
Up to Week 48
Reported as:
Count of participants · Participants
Number of Participants With Viral Resistance After Meeting Confirmed Virologic Withdrawal (CVW) Criterion
ParticipantsParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Number of Participants With Viral Resistance After Meeting Confirmed Virologic Withdrawal (CVW) Criterion0
SecondaryNumber of Participants With Viral Resistance After Meeting CVW Criterion

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame:
From Week 48 to Week 96

Results for this outcome have not been posted.

SecondaryNumber of Participants With Treatment Related Non-serious Adverse Events (AEs)

A treatment related non-serious AE is defined as any untoward medical occurrence in a clinical study participant considered related to the study treatment. Any = occurrence of the event regardless of intensity grade

Time frame:
Up to Week 48
Reported as:
Count of participants · Participants
Number of Participants With Treatment Related Non-serious Adverse Events (AEs)
ParticipantsParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Number of Participants With Treatment Related Non-serious Adverse Events (AEs)17
SecondaryNumber of Participants With Treatment Related Non-serious AEs

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame:
From Week 48 to Week 96

Results for this outcome have not been posted.

SecondaryNumber of Participants With Any Serious Adverse Events (SAEs)

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. Any = occurrence of the event regardless of intensity grade.

Time frame:
Up to Week 48
Reported as:
Count of participants · Participants
Number of Participants With Any Serious Adverse Events (SAEs)
ParticipantsParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Number of Participants With Any Serious Adverse Events (SAEs)26
SecondaryNumber of Participants With SAEs

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame:
From Week 48 to Week 96

Results for this outcome have not been posted.

SecondaryNumber of Participants With AEs Leading to Treatment Discontinuation
Time frame:
Up to Week 48
Reported as:
Count of participants · Participants
Number of Participants With AEs Leading to Treatment Discontinuation
ParticipantsParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Number of Participants With AEs Leading to Treatment Discontinuation9
SecondaryNumber of Participants With AEs Leading to Treatment Discontinuation

Data not available at the time of posting, will be updated at the final results disclosure stage.

Time frame:
From Week 48 to Week 96

Results for this outcome have not been posted.

Adverse events

Collected over Adverse events (AEs), Serious AEs (SAEs) and all-cause mortality were collected from Day 1 through Week 96. Results up to Week 48 are presented. Safety data post-week 48 will be provided at the final results disclosure stage.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)2/205 (1%)26/205 (12.7%)69/205 (33.7%)
Most frequent serious events
Showing 10 of 29
Most frequent serious events
EventParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Musculoskeletal chest painMusculoskeletal and connective tissue disorders2/205
Alcohol poisoningInjury, poisoning and procedural complications1/205
Head injuryInjury, poisoning and procedural complications1/205
Lower limb fractureInjury, poisoning and procedural complications1/205
Medication errorInjury, poisoning and procedural complications1/205
Periprosthetic fractureInjury, poisoning and procedural complications1/205
Radius fractureInjury, poisoning and procedural complications1/205
Skin injuryInjury, poisoning and procedural complications1/205
Complicated appendicitisInfections and infestations1/205
DiverticulitisInfections and infestations1/205
Most frequent other events
Showing 10 of 14
Most frequent other events
EventParticipants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
ArthralgiaMusculoskeletal and connective tissue disorders18/205
HeadacheNervous system disorders15/205
DiarrhoeaGastrointestinal disorders10/205
NauseaGastrointestinal disorders9/205
FatigueGeneral disorders9/205
COVID-19Infections and infestations9/205
Upper respiratory tract infectionInfections and infestations8/205
CoughRespiratory, thoracic and mediastinal disorders7/205
Pain in extremityMusculoskeletal and connective tissue disorders6/205
DizzinessNervous system disorders6/205

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Mean62.2 ± 7.46
Sex: Female, Male
Sex: Female, Male(Participants)Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
Female88
Male117
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Participants Receiving Dolutegravir/Lamivudine (DTG/3TC) Fixed-dose Combination (FDC)
American Indian or Alaska Native4
Asian3
Black or African American68
White125
Multiple1
Not reported1
Unknown3
08

Study locations

56 sites
  • GSK Investigational Site
    Phoenix, Arizona 85015, United States
  • GSK Investigational Site
    Bakersfield, California 93301, United States
  • GSK Investigational Site
    Palm Springs, California 92262, United States
  • GSK Investigational Site
    Washington D.C., District of Columbia 20005, United States
  • GSK Investigational Site
    Ft. Pierce, Florida 34982, United States
  • GSK Investigational Site
    Miami, Florida 33133, United States
  • GSK Investigational Site
    West Palm Beach, Florida 33407, United States
  • GSK Investigational Site
    Augusta, Georgia 30912, United States
  • GSK Investigational Site
    Decatur, Georgia 30033, United States
  • GSK Investigational Site
    Macon, Georgia 31201, United States
  • GSK Investigational Site
    Boston, Massachusetts 02043, United States
  • GSK Investigational Site
    Berkley, Michigan 48072, United States
  • GSK Investigational Site
    Detroit, Michigan 48202, United States
  • GSK Investigational Site
    Kansas City, Missouri 64111, United States
  • GSK Investigational Site
    Omaha, Nebraska 68198, United States
  • GSK Investigational Site
    Las Vegas, Nevada 89106, United States
  • GSK Investigational Site
    The Bronx, New York 10467, United States
  • GSK Investigational Site
    Charlotte, North Carolina 28204, United States
  • GSK Investigational Site
    Greensboro, North Carolina 27401, United States
  • GSK Investigational Site
    Wilmington, North Carolina 28401-7684, United States
  • GSK Investigational Site
    Akron, Ohio 44304, United States
  • GSK Investigational Site
    Portland, Oregon 97239, United States
  • GSK Investigational Site
    Philadelphia, Pennsylvania 19104, United States
  • GSK Investigational Site
    Austin, Texas 78705, United States
  • GSK Investigational Site
    Innsbruck, 6020, Austria
  • GSK Investigational Site
    Vienna, 1100, Austria
  • GSK Investigational Site
    Brussels, 1200, Belgium
  • GSK Investigational Site
    Ghent, 9000, Belgium
  • GSK Investigational Site
    Toronto, Ontario M5G 2N2, Canada
  • GSK Investigational Site
    Montreal, Quebec H2L 1N9, Canada
  • GSK Investigational Site
    Montreal, Quebec H4A 3J1, Canada
  • GSK Investigational Site
    Nice, 6202, France
  • GSK Investigational Site
    Orléans, 45100, France
  • GSK Investigational Site
    Paris, 75004, France
  • GSK Investigational Site
    Freiburg im Breisgau, 79106, Germany
  • GSK Investigational Site
    Hanover, 30625, Germany
  • GSK Investigational Site
    München, 80336, Germany
  • GSK Investigational Site
    Milan, 20142, Italy
  • GSK Investigational Site
    Modena, 41100, Italy
  • GSK Investigational Site
    Roma, 161, Italy
  • GSK Investigational Site
    Torino, 10149, Italy
  • GSK Investigational Site
    Mérida, 97070, Mexico
  • GSK Investigational Site
    Monterrey, 64460, Mexico
  • GSK Investigational Site
    Amsterdam, 1105 AZ, Netherlands
  • GSK Investigational Site
    Rotterdam, 3079 DZ, Netherlands
  • GSK Investigational Site
    Utrecht, 3584 CX, Netherlands
  • GSK Investigational Site
    Porto, 4099-001, Portugal
  • GSK Investigational Site
    Porto, 4200-319, Portugal
  • GSK Investigational Site
    Vila Nova de Gaia, 4434-502, Portugal
  • GSK Investigational Site
    Manresa, Catalonia 08243, Spain
  • GSK Investigational Site
    Sabadell, Catalonia 8208, Spain
  • GSK Investigational Site
    Guadalajara, 19002, Spain
  • GSK Investigational Site
    Zaragoza, 50009, Spain
  • GSK Investigational Site
    Liverpool, L7 8XP, United Kingdom
  • GSK Investigational Site
    London, SE1 9RT, United Kingdom
  • GSK Investigational Site
    London, SW7 2AZ, United Kingdom
09

References and documents

Study documents

  • Study protocol · Jul 9, 2025
  • Statistical analysis plan · Sep 12, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05911360
Lead sponsor
ViiV Healthcare
Responsible party
Sponsor
First posted
Jun 22, 2023
Start date
Jul 7, 2023
Primary completion
Jan 23, 2026
Completion
Feb 9, 2026
Results posted
May 14, 2026
Last update
Jul 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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