This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
473
Dolutegravir will be administered once daily.
Lamivudine will be administered once daily.
Bictegravir will be administered once daily.
Emtricitabine will be administered once daily.
Tenofovir alafenamide will be administered once daily.
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina
GSK Investigational Site
Córdoba, Argentina
GSK Investigational Site
Antwerp, Belgium
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
Percentage of participants with plasma HIV- Ribonucleic acid (RNA) less than (<)50 copies per milliliter (c/mL) as per snapshot algorithm at Week 48
Time frame: Week 48
Percentage of participants with plasma HIV-1 RNA <50 c/mL as per snapshot algorithm at Weeks 24 and 96
Time frame: 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
Time frame: Weeks 24, 48 and 96
Change from Baseline in HIV-1 RNA at Weeks 24, 48 and 96
Time frame: Baseline (Day 1) and Weeks 24, 48 and 96
Change from Baseline in Cluster of differentiation 4 positive (CD4+) cell count at Weeks 24, 48 and 96
Time frame: Baseline (Day 1) and Weeks 24, 48 and 96
Change from Baseline in CD4/Cluster of differentiation 8 (CD8) at Weeks 24, 48 and 96
Time frame: Baseline (Day 1) and Weeks 24, 48 and 96
Number of Participants With HIV-1 Disease Progression
Time frame: Weeks 24, 48 and 96
Time to virologic suppression (HIV-1 RNA <50 c/mL) from Baseline
Time frame: Baseline (Day 1) and Up to Week 96
Number of participants with confirmed virologic withdrawal (CVW)
Time frame: Up to Week 96
Number of Participants with treatment-emergent resistance
Time frame: Up to week 96
Change from Baseline in Renal Biomarkers- estimated glomerular filtration rate at Weeks 48 and 96
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in Renal Biomarkers- urinary protein/creatinine at Weeks 48 and 96
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in renal biomarker- Serum Cystatin C at Weeks 48 and 96 (Milligrams per liter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in renal biomarker- Serum Retinol Binding Protein (RBP) at Weeks 48 and 96 (Milligrams per deciliter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in renal biomarker- Serum Beta-2 Microglobulin (B2M) at Weeks 48 and 96 (Micrograms per milliliter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in bone biomarkers- Serum Bone Specific Alkaline Phosphatase, Serum Procollagen type 1 N- Propeptide, Serum Type I Collagen C-Telopeptides and Serum Osteocalcin at Weeks 48 and 96 (Micrograms per Liter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in bone biomarkers- Serum Vitamin D at Weeks 48 and 96 (Nanomoles per Liter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline (Week 4) in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction status Questionnaire (HIVTSQs) at Weeks 12, 24, 48 and 96 (Scores on a scale)
The HIVTSQ status version (HIVTSQs) is assessing participants' satisfaction with their current treatment with a Total score ranging from 0 to 60. Higher scores indicate a greater level of satisfaction with HIV treatment. Baseline is defined as measurement value at Week 4.
Time frame: Baseline (Week 4) and Weeks 12, 24, 48 and 96
Change from Baseline (Week 4) in Individual Item Scores Using HIVTSQs at Weeks12, 24, 48 and 96 (Scores on a scale)
Individual items scores range from 0 to 6 (0=very dissatisfied, 6=very satisfied). Baseline is defined as measurement value at Week 4.
Time frame: Baseline (Week 4) and Weeks 12, 24, 48 and 96
Change from Baseline (Week 4) in Domains Scores Using HIVTSQs at Weeks 12, 24, 48 and 96 (Scores on a scale)
There are two domain scores of General Satisfaction/Clinical and Lifestyle/Ease subscales; each comprised of 5 items with possible scores of 0 to 30. The higher the score, the greater the satisfaction within the subscale. Baseline is defined as measurement value at Week 4.
Time frame: Baseline (Week 4) and Weeks 12, 24, 48 and 96
Change from Baseline in bothersome symptoms using the Symptom Distress Module at Weeks 4, 12, 24, 48 and 96 (Score on a scale)
The Symptom Distress Module (SDM) is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom bother score is based on the score for each symptom present ranging from 1 (it does not bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score).
Time frame: Baseline (Day 1) and Weeks 4, 12, 24, 48 and 96
Absolute values for waist and hip circumference (Centimeters)
Time frame: Up to Week 96
Absolute values for waist to hip ratio and waist to height ratio (Ratio)
Time frame: Up to Week 96
Absolute values for Body weight (Kilogram)
Time frame: Up to Week 96
Absolute values for systolic and diastolic blood pressure (millimeters of mercury)
Time frame: Up to Week 96
Change from Baseline in Body Mass Index (kilogram per square meter)
Time frame: Baseline (Day 1) and Up to Week 96
Change from Baseline in body weight greater than (>) 5 percentage (%) at Weeks 24, 48 and 96
Time frame: Baseline (Day 1) and Weeks 24, 48 and 96
Change from Baseline in total and regional (trunk and extremities) fat assessed by Dual-energy X-ray absorptiometry (DXA) at Weeks 48 and 96
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in total and regional (trunk and extremities) fat-free mass assessed by DXA Weeks 48 and 96
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in lumbar and hip bone mineral density (BMD) assessed by DXA at Weeks 48 and 96
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in trabecular bone score (TBS) assessed by DXA at Weeks 48 and 96
Trabecular bone score (TBS) is a lumbar spine dual-energy absorptiometry texture index, which provides information on microarchitecture skeletal quality partially independent of BMD.
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in fasting glucose (Millimoles per Liter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in insulin (Microunits per millilliter)
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 48 and Week 96
Time frame: Baseline (Day 1), Week 48 and Week 96
Change from Baseline in Hemoglobin A1c [HbA1c] at Week 48 and Week 96 (Percentage of HbA1c)
Time frame: Baseline (Day 1), Week 48 and Week 96
Change from Baseline in plasma lipids (total, high-density lipoprotein [HDL], and low-density lipoprotein [LDL] cholesterol, triglycerides) (Millimoles per Liter) at Week 48 and Week 96
Time frame: Baseline (Day 1), Week 48 and Week 96
Change from Baseline in QDiabetes Score at Week 48 and Week 96 (Scores on a scale)
QDiabetes score defines the risk (percentage) of developing type 2 Diabetes in the next ten years. The score ranges from 0-100.
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in Fibrosis 4 (FIB-4) Score at Week 48 and Week 96 (Scores on a scale)
A value of FIB-4 scores below 1.30 is considered as low risk for advanced fibrosis; value of FIB-4 over 2.67 is considered as high risk for advanced fibrosis; and FIB-4 values between 1.30 and 2.67 are considered as intermediate risk of advanced fibrosis.
Time frame: Baseline (Day 1), Weeks 48 and 96
Number of participants with metabolic syndrome at Weeks 48 and 96
Time frame: Weeks 48 and 96
Change from Baseline in Framingham cardiovascular risk scores at Weeks 48 and 96 (Scores on a scale)
Coronary heart disease (CHD) risk at 10 years in percent (%) can be calculated with the help of the Framingham Risk Score. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.
Time frame: Baseline (Day 1), Weeks 48 and 96
Change from Baseline in Data collection on Adverse events of anti-HIV Drugs (DAD) cardiovascular risk scores at Weeks 48 and 96 (Scores on a scale)
Coronary heart disease (CHD) risk at 5 years in percent can be calculated with the help of the DAD Risk Score. The 5-year risk of CHD is classified as low (\<1%), moderate (1 to 5%), high (5 to 10%), or very high (\>10%).
Time frame: Baseline (Day 1), Weeks 48 and 96
Changes from Baseline in Systolic and diastolic blood pressure at Weeks 48 and 96 millimeters of mercury (mmHg)
Time frame: Baseline (Day 1), Weeks 48 and 96
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Hvidovre, Denmark
GSK Investigational Site
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GSK Investigational Site
Bordeaux, France
GSK Investigational Site
Lyon, France
GSK Investigational Site
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