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
NCT ID: NCT05911360
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
205 participants
INTERVENTIONAL
2023-01-31
2026-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants Receiving DTG/3TC FDC
DTG/3TC
DTG/3TC FDC will be administered once daily.
Interventions
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DTG/3TC
DTG/3TC FDC will be administered once daily.
Eligibility Criteria
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Inclusion Criteria
* Participants must have been on uninterrupted antiretroviral therapy (ART) for ≥1 year (except for brief periods \[less than 30 days\] where all ART was stopped due to tolerability and/or safety concerns).
* Participants must be on uninterrupted BIC/FTC/TAF for at least 6 months prior to Screening.
* Participants with plasma HIV-1 RNA \<50 c/mL at Screening.
* Participants with 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 be eligible upon discussion and agreement with the medical monitor.
Exclusion Criteria
* Participants with 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) are not exclusionary.
* Participants with signs and symptoms which, in the opinion of the Investigator, are suggestive of active severe acute respiratory syndrome-related coronavirus (SARS-CoV-2) infection within 14 days prior to enrolment.
* Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
* Evidence of hepatitis B virus (HBV) infection 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 are excluded;
2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded;
3. Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
* Participants with 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 with history of liver cirrhosis with or without hepatitis viral co-infection.
* Participants with untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.
* Participants with 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, contraindicates their participation.
* 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, poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
* Participants with 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 must be provided to ViiV after screening and before enrollment for review by ViiV Virology.
* Participants with any verified Grade 4 laboratory abnormality with the exception of Grade 4 lipid abnormalities.
* Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN) or ALT ≥3xULN and bilirubin ≥1.5xULN (with greater than \[\>\]35 percentage \[%\] direct bilirubin).
* Participant has estimated creatine clearance \<30 millilitres per minute (mL/min) per 1.73 square meter (m\^2) using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKD-EPIcr\_R) method.
50 Years
ALL
No
Sponsors
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ViiV Healthcare
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Liverpool, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Bakersfield, California, United States
GSK Investigational Site
Palm Springs, California, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Ft. Pierce, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Augusta, Georgia, United States
GSK Investigational Site
Decatur, Georgia, United States
GSK Investigational Site
Macon, Georgia, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Berkley, Michigan, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Charlotte, North Carolina, United States
GSK Investigational Site
Greensboro, North Carolina, United States
GSK Investigational Site
Wilmington, North Carolina, United States
GSK Investigational Site
Akron, Ohio, United States
GSK Investigational Site
Portland, Oregon, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Innsbruck, , Austria
GSK Investigational Site
Vienna, , Austria
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Ghent, , Belgium
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Nice, , France
GSK Investigational Site
Orléans, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Freiburg im Breisgau, , Germany
GSK Investigational Site
Hanover, , Germany
GSK Investigational Site
München, , Germany
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Modena, , Italy
GSK Investigational Site
Roma, , Italy
GSK Investigational Site
Torino, , Italy
GSK Investigational Site
Mérida, , Mexico
GSK Investigational Site
Monterrey, , Mexico
GSK Investigational Site
Amsterdam, , Netherlands
GSK Investigational Site
Rotterdam, , Netherlands
GSK Investigational Site
Utrecht, , Netherlands
GSK Investigational Site
Porto, , Portugal
GSK Investigational Site
Porto, , Portugal
GSK Investigational Site
Vila Nova de Gaia, , Portugal
GSK Investigational Site
Guadalajara, , Spain
GSK Investigational Site
Manresa Barcelona, , Spain
GSK Investigational Site
Sabadell Barcelona, , Spain
GSK Investigational Site
Zaragoza, , Spain
Countries
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Other Identifiers
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2022-503137-66-00
Identifier Type: OTHER
Identifier Source: secondary_id
219516
Identifier Type: -
Identifier Source: org_study_id
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