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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
205
DTG/3TC FDC will be administered once daily.
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
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Greater Than or Equal to (≥)50 Copies/Millilitre (c/mL) per Snapshot Algorithm at Week 48
Time frame: Week 48
Number of Participants With Plasma HIV-1 RNA ≥50 c/mL per Snapshot Algorithm at 24 and 96 Weeks
Time frame: Weeks 24 and 96
Number of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL per Snapshot Algorithm at 24, 48 and 96 Weeks
Time frame: Weeks 24,48, and 96
Absolute Values for Cluster of Differentiation 4 (CD4+) Cells Count at 24, 48 and 96 Weeks
Time frame: Weeks 24,48, and 96
Change From Baseline in CD4+ Cells Count at 24, 48 and 96 Weeks
Time frame: Baseline (Day 1) and at Weeks 24,48, and 96
Absolute Values for CD4: Cluster of Differentiation 8 (CD8) Ratio at 24, 48 and 96 Weeks
Time frame: Weeks 24,48, and 96
Change From Baseline in CD4:CD8 Ratio at 24, 48 and 96 Weeks
Time frame: Baseline (Day 1) and at Weeks 24,48, and 96
Number of Participants With Disease Progression Through Weeks 24, 48 and 96
Time frame: Weeks 24, 48, and 96
Number of Participants who Meet Confirmed Virologic Withdrawn Criterion With Viral Resistance Over Time
Time frame: Up to Week 96
Number of Participants With Treatment Related Non-serious Adverse Events, all Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation
A treatment related AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, and considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function.
Time frame: Up to Week 96
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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
...and 46 more locations