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HIVPhase 3EYEWITNESSNCT05911360

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 study testing DTG/3TC in people with HIV and HIV Infections, run by ViiV Healthcare at 56 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
HIV, HIV Infections
What is being tested?
DTG/3TC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
205 participants
Where
56 sitesin 12 countries
Study dates
7 Jul 2023to 9 Feb 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
  • Participants positive for HBsAg were excluded;
Show all 18Show fewer
  • Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, were excluded;
  • 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.

Trial locations and contacts

56 sites in 12 countries.

56 sites in 12 countries

United States24 sites

  • GSK Investigational Site

    Akron, Ohio, 44304

  • GSK Investigational Site

    Augusta, Georgia, 30912

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Bakersfield, California, 93301

  • GSK Investigational Site

    Berkley, Michigan, 48072

  • GSK Investigational Site

    Boston, Massachusetts, 02043

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982

  • GSK Investigational Site

    Greensboro, North Carolina, 27401

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • GSK Investigational Site

    Macon, Georgia, 31201

  • GSK Investigational Site

    Miami, Florida, 33133

  • GSK Investigational Site

    Omaha, Nebraska, 68198

  • GSK Investigational Site

    Palm Springs, California, 92262

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Phoenix, Arizona, 85015

  • GSK Investigational Site

    Portland, Oregon, 97239

  • GSK Investigational Site

    The Bronx, New York, 10467

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20005

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

  • GSK Investigational Site

    Wilmington, North Carolina, 28401-7684

Other trials in United States

Italy4 sites

  • GSK Investigational Site

    Milan, 20142

  • GSK Investigational Site

    Modena, 41100

  • GSK Investigational Site

    Roma, 161

  • GSK Investigational Site

    Torino, 10149

Other trials in Italy

Spain4 sites

  • GSK Investigational Site

    Guadalajara, 19002

  • GSK Investigational Site

    Manresa, Catalonia, 08243

  • GSK Investigational Site

    Sabadell, Catalonia, 8208

  • GSK Investigational Site

    Zaragoza, 50009

Other trials in Spain

Canada3 sites

  • GSK Investigational Site

    Montreal, Quebec, H2L 1N9

  • GSK Investigational Site

    Montreal, Quebec, H4A 3J1

  • GSK Investigational Site

    Toronto, Ontario, M5G 2N2

Other trials in Canada

France3 sites

  • GSK Investigational Site

    Nice, 6202

  • GSK Investigational Site

    Orléans, 45100

  • GSK Investigational Site

    Paris, 75004

Other trials in France

Germany3 sites

  • GSK Investigational Site

    Freiburg im Breisgau, 79106

  • GSK Investigational Site

    Hanover, 30625

  • GSK Investigational Site

    München, 80336

Other trials in Germany

Netherlands3 sites

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Rotterdam, 3079 DZ

  • GSK Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

Portugal3 sites

  • GSK Investigational Site

    Porto, 4099-001

  • GSK Investigational Site

    Porto, 4200-319

  • GSK Investigational Site

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

United Kingdom3 sites

  • GSK Investigational Site

    Liverpool, L7 8XP

  • GSK Investigational Site

    London, SE1 9RT

  • GSK Investigational Site

    London, SW7 2AZ

Other trials in United Kingdom

Austria2 sites

  • GSK Investigational Site

    Innsbruck, 6020

  • GSK Investigational Site

    Vienna, 1100

Other trials in Austria

Belgium2 sites

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Ghent, 9000

Other trials in Belgium

Mexico2 sites

  • GSK Investigational Site

    Mérida, 97070

  • GSK Investigational Site

    Monterrey, 64460

Other trials in Mexico

About this study

Official title: A Phase 3b, Multicenter, Single-arm, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to DTG/3TC Single Tablet Regimen Administered Once Daily From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in People Living With HIV of at Least 50 Years of Age Who Are Virologically Suppressed

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.

Conditions
HIV, HIV Infections
Being tested
DTG/3TC
Keywords
Human Immunodeficiency Virus (HIV)-1, Dolutegravir, Lamivudine, Bictegravir, Emtricitabine, Tenofovir alafenamide, Dovato, Biktarvy, Switch study, ≥50 years
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DTG/3TCDrug

    DTG/3TC FDC was administered once daily.

Study groups in NCT05911360
Study groupRoleWhat they receive
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).
Receives: Drug: DTG/3TC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Week 48

Secondary outcomes (28)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: At Week 96

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

    Measured: At Week 24

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: At Week 96

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

    Measured: At Week 24 compared to Baseline

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to Week 24

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

    Measured: Up to Week 48

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

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: From Week 48 to Week 96

  27. Number of Participants With AEs Leading to Treatment Discontinuation

    Measured: 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.

    Measured: From Week 48 to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start7 Jul 2023
  3. Primary completion23 Jan 2026
  4. Study completion9 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05911360
Sponsor's protocol ID
219516
Other IDs
2022-503137-66-00
Acronym
EYEWITNESS
Status last verified
Jun 2026
First submitted
9 Jun 2023
Last updated
9 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DTG/3TC in people with HIV and HIV Infections, run by ViiV Healthcare at 56 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Italy, Spain, Canada, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=)50 Copies/Millilitre (c/mL) at Week 48 (time frame: At Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05911360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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