- Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 24 [ Time Frame: Week 24 ]
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights.
- Time to Viral Suppression (HIV-1 RNA <50 c/mL) [ Time Frame: Up to Week 48 ]
Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. Median along with first Quartile and third Quartile have been presented.
- CD4+ Cell Counts at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ]
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry.
- Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 [ Time Frame: Baseline and Weeks 24, 48 ]
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted least mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor.
- Number of Participants With HIV-1 Disease Progression [ Time Frame: Up to Week 48 ]
HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death.
- Number of Participants With Treatment-emergent Genotypic Resistance [ Time Frame: Up to Week 48 ]
Number of participants, who meet confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data.
- Number of Participants With Treatment-emergent Phenotypic Resistance [ Time Frame: Up to Week 48 ]
Number of participants, who meet CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results were interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drugs (Abacavir [ABC], elvitegravir [EGV], raltegravir [RAL], zidovudine [AZT], stavudine [D4T], didanosine [DDI]), emtricitabine [FTC], tenofovir disiproxil fumarate [TDF]). Partially sensitive and resistant cells were considered resistant in this analysis. Number of participants with phenotype at time of CVW by phenotypic cut-off at or prior to Week 48 have been presented. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
- Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) [ Time Frame: Up to Week 48 ]
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. Analyses presented herein used a data cut-off date of 22 May 2018 (for Week 48 database freeze), i.e. may include data collected after a participant's Week 48 visit.
- Number of Participants With AEs by Maximum Severity Grades [ Time Frame: Up to Week 48 ]
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. Analyses presented herein used a data cut-off date of 22 May 2018 (for Week 48 database freeze), i.e. may include data collected after a participant's Week 48 visit.
- Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade [ Time Frame: Up to Week 48 ]
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5. (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with drug related AEs and drug related AEs by by maximum grade have been presented. Analyses presented herein used a data cut-off date of 22 May 2018 (for Week 48 database freeze), i.e. may include data collected after a participant's Week 48 visit.
- Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities [ Time Frame: Up to Week 48 ]
Blood samples were collected up to Week 48 for assessment of platelet count, neutrophils, hemoglobin, and Leukocytes. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented.
- Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities [ Time Frame: Up to Week 48 ]
Blood samples were collected up to Week 48 for assessment of Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Albumin, Alkaline Phosphatase (ALP), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CPK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia and Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase and Phosphate. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented.
- Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48 [ Time Frame: Weeks 24 and 48 ]
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. Analyses presented herein used a data cut-off date of 19 January 2018 and 22 May 2018, respectively, for the Week 24 database freeze and Week 48 database freeze), i.e. may include data collected after a participant's Week 24 or 48 visit, respectively.
- Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 [ Time Frame: Baseline and at Weeks 24, 48 ]
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C and Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.
- Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 [ Time Frame: Baseline and at Weeks 24, 48 ]
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted) and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.
- Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 [ Time Frame: Baseline and at Weeks 24, 48 ]
Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
- Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 [ Time Frame: Baseline and Weeks 24, 48 ]
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Geometric mean ratio and 95% CI of geometric mean ratio have been presented. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor.
- Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 [ Time Frame: Baseline (Day 1) and at Weeks 24, 48 ]
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value.
- Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 [ Time Frame: Baseline and at Weeks 24, 48 ]
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value.
- Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 [ Time Frame: Baseline and at Weeks 24, 48 ]
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value).
- Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 [ Time Frame: Baseline (Day 1) and at Weeks 24, 48 ]
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). Lipid last observation carried forwardd (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Participants on lipid-lowering agents at Baseline were excluded.
- Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 [ Time Frame: Weeks 24 and 48 ]
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values.
- Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 [ Time Frame: Week 24 ]
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000 c/mL) and Race (White, African American/African heritage, Asian other).
- Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 [ Time Frame: Week 48 ]
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other).
- Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups [ Time Frame: Baseline (Day 1) and Week 48 ]
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the inidicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.
- Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups [ Time Frame: Baseline (Day 1) and Week 24 ]
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.
- Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24 48 [ Time Frame: Baseline (Day 1) and Weeks 4, 24, 48 ]
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Only those participants available at the specified time points were analyzed.
- Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48 [ Time Frame: Baseline (Day 1) and Weeks 4, 24, 48 ]
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
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- Percentage of subjects with plasma HIV 1 RNA <50 copies/milliliter at Weeks 24, 96, and 144 [ Time Frame: Week 24, 96, and 144 ]
The proportion of responders (HIV-1 RNA <50 copies/mL) among randomized subjects in the ITT-E population will be assessed at Weeks 24, 96 and 144 according to the FDA's Snapshot algorithm
- Time to viral suppression (HIV 1 RNA <50 copies/milliliter) over time [ Time Frame: Up to Week 144 ]
Time to HIV-1 RNA <50 copies/mL
- Absolute values in CD4+ cell counts at Weeks 24, 48, 96 and 144 [ Time Frame: Weeks 24, 48, 96 and 144 ]
Blood samples will be collected for assessment of lymphocytes by flow cytometry
- Number of subjects with disease progression (HIV associated conditions, acquired immunodeficiency syndrome, and death) over time [ Time Frame: Up to Week 144 ]
Antiviral and immunological activity evaluated by incidence of disease progression (HIV-associated conditions, Acquired immune deficiency syndrome and death) over time
- Incidence of treatment-emergent genotypic resistance to DTG and 3TC or TDF/FTC in subjects meeting confirmed virologic withdrawal criteria [ Time Frame: Up to end of study (Approximately 7 years) ]
Viral genotype for both Baseline samples and from samples collected at the time of meeting a virologic withdrawal criterion may be analysed
- Number of subjects with adverse events (AEs), severity of AEs and treatment discontinuations due to AEs over time [ Time Frame: Up to end of study (Approximately 7 years) ]
Safety and tolerability of DTG + 3TC will be compared to DTG + TDF/FTC over time. An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
- Change from Baseline in renal biomarkers [ Time Frame: Baseline (Day 1), Weeks 24, 48, 96 and 144 ]
Safety will be assessed in terms of biomarkers. Blood and urine samples will be collected for renal biomarker assessments.
- Change from Baseline in fasting lipids [ Time Frame: Baseline (Day 1), Weeks 24, 48, 96 and 144 ]
Samples for lipid measurements will be obtained in a fasted state. Effects of DTG + 3TC on fasting lipids will be compared to DTG + TDF/FTC.
- Number of subjects with Grade 2 or greater laboratory abnormalities in fasting low density lipoprotein cholesterol over time [ Time Frame: Weeks 24, 48, 96 and 144 ]
Samples for lipid measurements will be obtained in a fasted state. Grade 2 or 3 low density lipoprotein cholesterol (as per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events).
- Percentage of subjects with plasma HIV 1 RNA <50 c/mL by subgroups based on age, gender, Baseline CD4+ cell count [ Time Frame: Weeks 24, 48, 96 and 144 ]
Impact of age, gender, Baseline CD4+ cell count on antiviral activity of DTG + 3TC compared to DTG + TDF/FTC
- Change from Baseline in CD4+ cell count by patient subgroups based on age, gender, Baseline CD4+ cell count [ Time Frame: Baseline (Day 1), Weeks 24, 48, 96 and 144 ]
Impact of age, gender, Baseline CD4+ cell count on immunological activity of DTG + 3TC compared to DTG + TDF/FTC
- Change from Baseline in health related quality of life [ Time Frame: Baseline (Day 1), Weeks 4, 24, 48, 96 and 144 ]
The European quality of life 5 dimensions 5 levels (EQ-5D-5L), is a self-reported scale that provides a profile of patient function (including mobility, self care, usual activities, pain/discomfort, and anxiety/depression) and a global health state rating.
- Changes from Baseline in CD4+ cell counts at Weeks 24, 48, 96 and 144 [ Time Frame: Baseline (Day 1), Weeks 24, 48, 96 and 144 ]
Blood samples will be collected for assessment of lymphocytes by flow cytometry
- Incidence of treatment-emergent phenotypic resistance to DTG and 3TC or TDF/FTC in subjects meeting confirmed virologic withdrawal criteria [ Time Frame: Up to end of study (Approximately 7 years) ]
Viral phenotype for both Baseline samples and from samples collected at the time of meeting a virologic withdrawal criterion may be analysed
- Change from Baseline in bone biomarkers [ Time Frame: Baseline (Day 1), Weeks 24, 48, 96 and 144 ]
Safety will be assessed in terms of biomarkers. Blood samples will be collected for bone biomarker assessments.
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