A Phase 3 interventional study of Dolutegravir/abacavir/lamivudine FDC and Atazanavir in Infection, Human Immunodeficiency Virus and HIV Infections, sponsored by ViiV Healthcare. Completed at 90 sites in 13 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by ViiV Healthcare · Phase 3, Interventional, and Treatment
This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC. Sufficient number of subjects will be screened in order to ensure a total of approximately 474 subjects will be randomized (237 in each study arm)
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 499 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
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Exclusion Criteria:
As per the randomization schedule subjects will be administered with DTG/ABC/3TC (50mg/600mg/300mg) FDC tablet OD up to Week 48 and if continued if applicable in the Continuation Phase. DTG/ABC/3TC FDC may be administered with or without food
Drug: Dolutegravir/abacavir/lamivudine FDC
As per the randomization schedule subjects will be administered with ATV (300mg capsule) +RTV (100mg tablet) + TDF/FTC (300mg/200mg tablet) FDC OD up to Week 48. ATV+RTV+ TDF/FTC FDC must be taken with food
Drug: Atazanavir · Drug: Ritonavir · Drug: Tenofovir/emtricitabine FDC
Dolutegravir/abacavir/lamivudine FDC tablets, 50 mg/600 mg/300 mg
Atazanavir capsule 300 mg
Ritonavir tablet 100 mg
Tenofovir/emtricitabine FDC tablet 300 mg/200 mg of FTC
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48
Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =\<vs. \>100,000 c/mL) and CD4+ cell count (=\<350 cells per millimeter cube (cells/mm\^3) or \>350 cells/mm\^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.
Time frame: Week 48
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase
Percentage of participants with plasma HIV-1 RNA \<50 and \<400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \<50 c/mL were reported. Percentage values are rounded off.
Time frame: Week 96 and Week 432
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 96 and Week 432
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
Absolute Values in plasma HIV-1 RNA were assessed at indicated time points.
Time frame: Week 96 and Week 432
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 96, Week 432
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
Absolute values in CD4+ cell count were assessed at indicated time points.
Time frame: Week 96 and Week 432
Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol \[CHLS\], high density lipoprotein \[HDL\] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Albumin at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Creatinine Clearance at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Lipase at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Erythrocytes at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Hematocrit Count at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Triglycerides at Week 48
Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
Time frame: Baseline (Day 1) and Week 48
Change From Baseline in TC/HDL Ratio at Week 48
Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
Time frame: Baseline (Day 1) and Week 48
Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points
Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Week 24 and Week 48
Number of Participants With AEs by Maximum Toxicity-Randomized Phase
Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.
Time frame: Up to Week 48
Number of Participants With AEs by Maximum Toxicity-Continuation Phase
Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.
Time frame: From Weeks 48 to 432
Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is 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, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.
Time frame: Up to Week 48
Number of Participants With Any AEs, and SAEs in Continuation Phase
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is 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, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.
Time frame: From Weeks 48 to 432
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase
Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.
Time frame: Up to Week 48
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase
Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.
Time frame: From Weeks 48 to 432
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase
Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.
Time frame: Up to Week 48
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase
Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.
Time frame: From Weeks 48 to 432
Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. 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, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.
Time frame: Up to Week 48
Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. 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, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.
Time frame: From Weeks 48 to 432
Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Weeks 24 and 48
Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Weeks 24 and 48
Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1), Weeks 24 and 48
Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline
Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.
Time frame: Baseline (Day 1) and Week 48
Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS
The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and Week 48
HIVTSQs Total Score at Indicated Timepoints
The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test.
Time frame: Weeks 4, 12, 24 and 48
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups
Percentage of participants with plasma HIV-1 RNA \<50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA \[BPHR\], Baseline CD4+ cell count \[BCCC\], Baseline Centers for Disease Control and Prevention \[CDC\] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =\<versus \[vs\]. \>100,000 c/mL) and CD4+ cell count (=\<350 cells/mm\^3 or \>350 cells/mm\^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off.
Time frame: Week 48
Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase
Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
Time frame: Up to week 48
Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
Time frame: Up to week 432
Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.
Time frame: Up to week 432
Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)
Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.
Time frame: Up to week 48
The study consists of a Screening (14-28 days), Randomized (48 weeks) and Continuation (Cont.) Phase. Participants were said to have completed the study if they completed the Randomized phase and did not enter the Cont. Phase. Participants entering the Cont. Phase were said to have completed the study if they completed both phases of the study.
| Milestone | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|---|---|
| Started | 250 | 249 | 0 |
| Itt-e population | 248 | 247 | 0 |
| Completed | 206 | 192 | 0 |
| Not completed | 44 | 57 | 0 |
| Withdrew: Adverse event | 10 | 18 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 5 | 4 | 0 |
| Withdrew: Lost to follow-up | 11 | 13 | 0 |
| Withdrew: Withdrawal by subject | 5 | 7 | 0 |
| Withdrew: Randomized, but did not receive treatment | 2 | 2 | 0 |
| Withdrew: Protocol deviation | 10 | 13 | 0 |
| Milestone | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|---|---|
| Started | 0 | 0 | 149 |
| Completed | 0 | 0 | 113 |
| Not completed | 0 | 0 | 36 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 4 |
| Withdrew: Withdrawal by subject | 0 | 0 | 7 |
| Withdrew: Lost to follow-up | 0 | 0 | 8 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 |
| Withdrew: Protocol deviation | 0 | 0 | 15 |
Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =\<vs. \>100,000 c/mL) and CD4+ cell count (=\<350 cells per millimeter cube (cells/mm\^3) or \>350 cells/mm\^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.
| Percentage of participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 | 82 | 71 |
Percentage of participants with plasma HIV-1 RNA \<50 and \<400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off.
| Percentage of participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| HIV-1 RNA <50 c/mL, Baseline (Day 1) | 0 | 0 |
| HIV-1 RNA <50 c/mL, Week 4 | 64 | 13 |
| HIV-1 RNA <50 c/mL, Week 12 | 81 | 49 |
| HIV-1 RNA <50 c/mL, Week 24 | 85 | 77 |
| HIV-1 RNA <50 c/mL, Week 36 | 85 | 77 |
| HIV-1 RNA <50 c/mL, Week 48 | 82 | 71 |
| HIV-1 RNA <400 c/mL, Baseline (Day 1) | 1 | 1 |
| HIV-1 RNA <400 c/mL, Week 4 | 90 | 54 |
| HIV-1 RNA <400 c/mL, Week 12 | 91 | 84 |
| HIV-1 RNA <400 c/mL, Week 24 | 88 | 82 |
| HIV-1 RNA <400 c/mL, Week 36 | 86 | 81 |
| HIV-1 RNA <400 c/mL, Week 48 | 83 | 76 |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \<50 c/mL were reported. Percentage values are rounded off.
| Percentage of participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|
| Week 96, n=99 | 100 |
| Week 432, n=3 | 100 |
Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Log10 copies/mL | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 4, n=245, 238 | -2.591 ± 0.8015 | -1.923 ± 0.5330 |
| Week 12, n=236, 226 | -2.756 ± 0.8920 | -2.541 ± 0.7373 |
| Week 24, n=225, 212 | -2.789 ± 0.9160 | -2.726 ± 0.8890 |
| Week 36, n=221, 204 | -2.838 ± 0.8589 | -2.772 ± 0.8451 |
| Week 48, n=207, 192 | -2.874 ± 0.8035 | -2.752 ± 0.8433 |
Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Log10 copies/mL | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|
| Week 96, n=99 | -2.911 ± 0.7970 |
| Week 432, n=3 | -3.107 ± 0.7659 |
Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.
| Log10 copies/mL | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Baseline (Day 1), n=248, 247 | 4.481 ± 0.8111 | 4.441 ± 0.8023 |
| Week 4, n=245, 238 | 1.895 ± 0.6872 | 2.516 ± 0.6193 |
| Week 12, n=236, 226 | 1.748 ± 0.5458 | 1.908 ± 0.4926 |
| Week 24, n=225, 212 | 1.724 ± 0.5935 | 1.710 ± 0.4484 |
| Week 36, n=221, 204 | 1.666 ± 0.3982 | 1.658 ± 0.3362 |
| Week 48, n=207, 192 | 1.619 ± 0.1986 | 1.657 ± 0.2743 |
Absolute Values in plasma HIV-1 RNA were assessed at indicated time points.
| Log10 copies/mL | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|
| Week 96, n=99 | 1.591 ± 0.0080 |
| Week 432, n=3 | 1.590 ± 0.0000 |
Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Cells per cubic millimeter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 4, n=245, 237 | 94.9 ± 140.02 | 73.7 ± 108.15 |
| Week 12, n=236, 224 | 143.8 ± 142.19 | 124.4 ± 133.60 |
| Week 24, n=226, 210 | 200.6 ± 162.37 | 163.0 ± 126.67 |
| Week 36, n=219, 204 | 230.7 ± 163.61 | 191.4 ± 167.24 |
| Week 48, n=208, 191 | 248.8 ± 172.01 | 230.7 ± 189.59 |
Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Cells per cubic millimeter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|
| Week 96, n=99 | 286.5 ± 196.77 |
| Week 432, n=3 | 254.7 ± 342.31 |
Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.
| Cells per cubic millimeter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Baseline (Day 1), n=248, 247 | 369.7 ± 225.67 | 380.3 ± 223.60 |
| Week 4, n=245, 237 | 465.0 ± 252.51 | 455.1 ± 244.62 |
| Week 12, n=236, 224 | 509.5 ± 276.79 | 506.2 ± 266.84 |
| Week 24, n=226, 210 | 563.8 ± 303.10 | 542.5 ± 265.69 |
| Week 36, n=219, 204 | 592.8 ± 291.62 | 569.2 ± 299.77 |
| Week 48, n=208, 191 | 608.8 ± 298.95 | 608.5 ± 302.58 |
Absolute values in CD4+ cell count were assessed at indicated time points.
| Cells per cubic millimeter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|
| Week 96, n=99 | 635.3 ± 285.85 |
| Week 432, n=3 | 553.0 ± 341.63 |
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol \[CHLS\], high density lipoprotein \[HDL\] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment.
| Millimoles per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Carbon Dioxide, Week 4, n= 244, 237 | -0.4 ± 2.29 | 0.6 ± 2.2 |
| Carbon Dioxide, Week 12, n= 236, 226 | -0.2 ± 2.2 | 0.8 ± 2.19 |
| Carbon Dioxide, Week 24, n= 224, 212 | -0.5 ± 2.31 | 0.3 ± 2.38 |
| Carbon Dioxide, Week 36, n= 219, 204 | 0 ± 2.34 | 0.6 ± 2.5 |
| Carbon Dioxide, Week 48, n= 208, 192 | -0.6 ± 2.55 | 0.4 ± 2.46 |
| Chloride, Week 4, n= 245, 237 | 0.6 ± 2.42 | -0.5 ± 2.68 |
| Chloride, Week 12, n= 236, 226 | 1 ± 2.51 | 0.2 ± 2.58 |
| Chloride, Week 24, n= 225, 212 | 0.7 ± 2.71 | -0.1 ± 2.58 |
| Chloride, Week 36, n= 219, 204 | 0.9 ± 2.65 | 0 ± 2.96 |
| Chloride, Week 48, n= 208, 192 | 0.7 ± 2.42 | 0 ± 2.63 |
| CHLS, Week 4, n= 1, 3 | -0.1 ± NA | -0.017 ± 0.446 |
| CHLS, Week 12, n= 224, 221 | 0.298 ± 0.7492 | -0.058 ± 0.7137 |
| CHLS, Week 24, n= 218, 201 | 0.317 ± 0.7254 | -0.001 ± 0.7456 |
| CHLS, Week 36, n= 205, 191 | 0.33 ± 0.7328 | 0 ± 0.7509 |
| CHLS, Week 48, n= 195, 175 | 0.447 ± 0.7441 | 0.109 ± 0.7647 |
| Glucose, Week 12, n= 226, 224 | 0.3 ± 1.359 | 0.22 ± 1.234 |
| Glucose, Week 24, n= 219, 204 | 0.17 ± 0.811 | 0.26 ± 1.248 |
| Glucose, Week 36, n= 211, 196 | 0.17 ± 1.24 | 0.34 ± 1.753 |
| Glucose, Week 48, n= 197, 180 | 0.18 ± 1.01 | 0.24 ± 1.377 |
| HDL CHLS, Direct, Week 4, n= 1, 3 | -0.1 ± NA | 0 ± 0.0529 |
| HDL CHLS, Direct, Week 12, n= 224, 221 | 0.182 ± 0.3407 | 0.005 ± 0.2316 |
| HDL CHLS, Direct, Week 24, n= 218, 201 | 0.201 ± 0.2962 | 0.053 ± 0.2819 |
| HDL CHLS, Direct, Week 36, n= 205, 191 | 0.204 ± 0.2943 | 0.036 ± 0.2848 |
| HDL CHLS, Direct, Week 48, n= 195, 175 | 0.231 ± 0.2911 | 0.081 ± 0.2964 |
| Hyperglycaemia, Week 12, n= 226, 224 | 0.3 ± 1.359 | 0.22 ± 1.234 |
| Hyperglycaemia, Week 24, n= 219, 204 | 0.17 ± 0.811 | 0.26 ± 1.248 |
| Hyperglycaemia, Week 36, n= 211, 196 | 0.17 ± 1.24 | 0.34 ± 1.753 |
| Hyperglycaemia, Week 48, n= 197, 180 | 0.18 ± 1.01 | 0.24 ± 1.377 |
| Hyperkalemia, Week 4, n= 244, 237 | -0.01 ± 0.344 | 0.12 ± 0.367 |
| Hyperkalemia, Week 12, n= 236, 226 | 0.03 ± 0.355 | 0.1 ± 0.39 |
| Hyperkalemia, Week 24, n= 224, 212 | -0.04 ± 0.339 | 0.06 ± 0.372 |
| Hyperkalemia, Week 36, n= 219, 204 | 0.03 ± 0.332 | 0.13 ± 0.387 |
| Hyperkalemia, Week 48, n= 208, 192 | -0.04 ± 0.346 | 0.04 ± 0.372 |
| Hypernatremia, Week 4, n= 245, 237 | 0 ± 2.11 | -0.5 ± 2.4 |
| Hypernatremia, Week 12, n= 236, 226 | 0.7 ± 2.3 | 0.1 ± 2.51 |
| Hypernatremia, Week 24, n= 225, 212 | 0.6 ± 2.3 | 0.2 ± 2.11 |
| Hypernatremia, Week 36, n= 219, 204 | 0.9 ± 2.32 | 0.2 ± 2.5 |
| Hypernatremia, Week 48, n= 208, 192 | 0.6 ± 2.24 | 0.5 ± 2.39 |
| Hypoglycaemia, Week 12, n= 226, 224 | 0.3 ± 1.359 | 0.22 ± 1.234 |
| Hypoglycaemia, Week 24, n= 219, 204 | 0.17 ± 0.811 | 0.26 ± 1.248 |
| Hypoglycaemia, Week 36, n= 211, 196 | 0.17 ± 1.24 | 0.34 ± 1.753 |
| Hypoglycaemia, Week 48, n= 197, 180 | 0.18 ± 1.01 | 0.24 ± 1.377 |
| Hypokalemia, Week 4, n= 244, 237 | -0.01 ± 0.344 | 0.12 ± 0.367 |
| Hypokalemia, Week 12, n= 236, 226 | 0.03 ± 0.355 | 0.1 ± 0.39 |
| Hypokalemia, Week 24, n= 224, 212 | -0.04 ± 0.339 | 0.06 ± 0.372 |
| Hypokalemia, Week 36, n= 219, 204 | 0.03 ± 0.332 | 0.13 ± 0.387 |
| Hypokalemia, Week 48, n= 208, 192 | -0.04 ± 0.346 | 0.04 ± 0.372 |
| Hyponatremia, Week 4, n= 245, 237 | 0 ± 2.11 | -0.5 ± 2.4 |
| Hyponatremia, Week 12, n= 236, 226 | 0.7 ± 2.3 | 0.1 ± 2.51 |
| Hyponatremia, Week 24, n= 225, 212 | 0.6 ± 2.3 | 0.2 ± 2.11 |
| Hyponatremia, Week 36, n= 219, 204 | 0.9 ± 2.32 | 0.2 ± 2.5 |
| Hyponatremia, Week 48, n= 208, 192 | 0.6 ± 2.24 | 0.5 ± 2.39 |
| LDL CHLS Calculation, Week 4, n= 1, 3 | 0.08 ± NA | -0.123 ± 0.5255 |
| LDL CHLS Calculation, Week 12, n= 221, 219 | 0.125 ± 0.6045 | -0.14 ± 0.6114 |
| LDL CHLS Calculation, Week 24, n= 213, 201 | 0.111 ± 0.6209 | -0.111 ± 0.6188 |
| LDL CHLS Calculation, Week 36, n= 201, 188 | 0.112 ± 0.6385 | -0.099 ± 0.6049 |
| LDL CHLS Calculation, Week 48, n= 190, 175 | 0.213 ± 0.6499 | -0.021 ± 0.6227 |
| LDL CHLS, Direct, Week 12, n= 0, 1 | — | -0.44 ± NA |
| LDL CHLS, Direct, Week 24, n= 1, 0 | -0.64 ± NA | — |
| LDL CHLS, Direct, Week 36, n= 1, 0 | -0.23 ± NA | — |
| Phosphate, Week 4, n= 245, 237 | 0 ± 0.1461 | -0.032 ± 0.1726 |
| Phosphate, Week 12, n= 236, 226 | 0.02 ± 0.1694 | 0.026 ± 0.1634 |
| Phosphate, Week 24, n= 225, 212 | 0.021 ± 0.1628 | 0.026 ± 0.1701 |
| Phosphate, Week 36, n= 219, 204 | 0.029 ± 0.1736 | 0.009 ± 0.1675 |
| Phosphate, Week 48, n= 208, 192 | 0.016 ± 0.1736 | 0 ± 0.1673 |
| Potassium, Week 4, n= 244, 237 | -0.01 ± 0.344 | 0.12 ± 0.367 |
| Potassium, Week 12, n= 236, 226 | 0.03 ± 0.355 | 0.1 ± 0.39 |
| Potassium, Week 24, n= 224, 212 | -0.04 ± 0.339 | 0.06 ± 0.372 |
| Potassium, Week 36, n= 219, 204 | 0.03 ± 0.332 | 0.13 ± 0.387 |
| Potassium, Week 48, n= 208, 192 | -0.04 ± 0.346 | 0.04 ± 0.372 |
| Sodium, Week 4, n= 245, 237 | 0 ± 2.11 | -0.5 ± 2.4 |
| Sodium, Week 12, n= 236, 226 | 0.7 ± 2.3 | 0.1 ± 2.51 |
| Sodium, Week 24, n= 225, 212 | 0.6 ± 2.3 | 0.2 ± 2.11 |
| Sodium, Week 36, n= 219, 204 | 0.9 ± 2.32 | 0.2 ± 2.5 |
| Sodium, Week 48, n= 208, 192 | 0.6 ± 2.24 | 0.5 ± 2.39 |
| Triglycerides, Week 4, n= 1, 3 | -0.18 ± NA | 0.237 ± 0.2491 |
| Triglycerides, Week 12, n= 224, 221 | -0.04 ± 0.6861 | 0.167 ± 0.7074 |
| Triglycerides, Week 24, n= 218, 201 | 0.036 ± 0.7108 | 0.125 ± 0.6132 |
| Triglycerides, Week 36, n= 205, 191 | 0.037 ± 0.6732 | 0.157 ± 0.6785 |
| Triglycerides, Week 48, n= 195, 175 | 0.018 ± 0.8158 | 0.107 ± 0.5527 |
| Urea, Week 4, n= 245, 237 | -0.04 ± 1.085 | 0.1 ± 1.313 |
| Urea, Week 12, n= 236, 226 | 0.08 ± 1.097 | 0.16 ± 1.409 |
| Urea, Week 24, n= 225, 212 | 0.03 ± 1.187 | 0.12 ± 1.283 |
| Urea, Week 36, n= 219, 204 | 0.08 ± 1.236 | -0.03 ± 1.256 |
| Urea, Week 48, n= 208, 192 | 0.1 ± 1.162 | 0.02 ± 1.179 |
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Micromoles per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Bilirubin, Week 4, n= 244, 237 | -0.8 ± 2.59 | 27.2 ± 23.15 |
| Bilirubin, Week 12, n= 236, 226 | -0.6 ± 2.65 | 22.8 ± 16.49 |
| Bilirubin, Week 24, n= 225, 212 | -0.2 ± 3.06 | 25 ± 18.38 |
| Bilirubin, Week 36, n= 219, 204 | -0.2 ± 3.01 | 23.8 ± 16.31 |
| Bilirubin, Week 48, n= 208, 192 | -0.3 ± 3.08 | 23.7 ± 17 |
| Creatinine, Week 4, n= 245, 237 | 8.4 ± 7.057 | 4.89 ± 7.109 |
| Creatinine, Week 12, n= 236, 226 | 9.2 ± 8.288 | 5.83 ± 8.357 |
| Creatinine, Week 24, n= 225, 212 | 9.16 ± 9.983 | 5.8 ± 8.063 |
| Creatinine, Week 36, n= 219, 204 | 10.08 ± 10.473 | 5.37 ± 9.013 |
| Creatinine, Week 48, n= 208, 192 | 9.29 ± 8.614 | 5.86 ± 10.252 |
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Grams per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 4, n= 245, 237 | 0.1 ± 2.36 | -0.5 ± 2.59 |
| Week 12, n= 236, 226 | 0.5 ± 2.95 | 0.1 ± 2.59 |
| Week 24, n= 225, 212 | 1.4 ± 3.2 | 0.8 ± 2.95 |
| Week 36, n= 219, 204 | 1.4 ± 3.09 | 0.6 ± 2.96 |
| Week 48, n= 208, 192 | 1.7 ± 3.17 | 1.3 ± 3.04 |
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| International units per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Alanine aminotransferase, Week 4, n= 245, 237 | -3.3 ± 27.54 | -3.4 ± 15.86 |
| Alanine aminotransferase, Week 12, n= 236, 226 | -5.2 ± 27.51 | -2.3 ± 20.26 |
| Alanine aminotransferase, Week 24, n= 225, 212 | -5.4 ± 27.92 | -3.7 ± 20.7 |
| Alanine aminotransferase, Week 36, n= 219, 204 | -4.9 ± 36.11 | -5.3 ± 20.08 |
| Alanine aminotransferase, Week 48, n= 208, 192 | -5.7 ± 28.54 | -1.5 ± 31.53 |
| Alkaline phosphatase, Week 4, n= 245, 237 | -1.5 ± 14.56 | 9.4 ± 28.69 |
| Alkaline phosphatase, Week 12, n= 236, 226 | -2.1 ± 17.1 | 15.1 ± 30.82 |
| Alkaline phosphatase, Week 24, n= 225, 212 | 0.5 ± 17.86 | 22.4 ± 41.59 |
| Alkaline phosphatase, Week 36, n= 219, 204 | 0.6 ± 19.19 | 20.4 ± 30.7 |
| Alkaline phosphatase, Week 48, n= 208, 192 | 2.9 ± 28.05 | 21.9 ± 25.35 |
| Aspartate aminotransferase, Week 4, n= 244, 237 | -3.3 ± 29.8 | -3.6 ± 18.83 |
| Aspartate aminotransferase, Week 12, n= 236, 226 | -6.2 ± 21.11 | -4 ± 13.79 |
| Aspartate aminotransferase, Week 24, n= 224, 212 | -6.3 ± 22.44 | -5.1 ± 13.8 |
| Aspartate aminotransferase, Week 36, n= 219, 204 | -6.4 ± 31.42 | -6.5 ± 16.63 |
| Aspartate aminotransferase, Week 48, n= 208, 192 | -7.5 ± 22.19 | -3.7 ± 25.28 |
| Creatine Kinase, Week 4, n= 245, 237 | -0.3 ± 68.72 | 35.6 ± 549.1 |
| Creatine Kinase, Week 12, n= 236, 226 | 6.9 ± 73.7 | 7.3 ± 90.39 |
| Creatine Kinase, Week 24, n= 225, 212 | 10.3 ± 88.66 | 5.8 ± 77.12 |
| Creatine Kinase, Week 36, n= 219, 204 | 11.9 ± 155.68 | 7.2 ± 132.74 |
| Creatine Kinase, Week 48, n= 208, 192 | 23.8 ± 242.66 | 3.8 ± 98.58 |
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Milliliter per minute | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 4, n= 245, 237 | -16.3 ± 15.03 | -7.5 ± 12.91 |
| Week 12, n= 236, 226 | -17.3 ± 17.01 | -7 ± 23.14 |
| Week 24, n= 225, 212 | -16.2 ± 20.36 | -9.1 ± 16.88 |
| Week 36, n= 219, 204 | -16.8 ± 22.35 | -7.5 ± 17.67 |
| Week 48, n= 208, 192 | -15.9 ± 19.62 | -7.7 ± 18.42 |
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Units per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 4, n= 245, 237 | -1.2 ± 15.06 | -1.3 ± 15.81 |
| Week 12, n= 236, 226 | -2.2 ± 22.74 | -2.1 ± 29 |
| Week 24, n= 225, 212 | -6 ± 21.05 | -6 ± 18.57 |
| Week 36, n= 219, 204 | -6.3 ± 25.62 | -6.3 ± 21.36 |
| Week 48, n= 208, 192 | -6.5 ± 29.63 | -7.8 ± 20.72 |
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Ratio | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 4, n= 1, 4 | 0.1264 ± NA | 0.2159 ± 0.60727 |
| Week 12, n= 233, 223 | -0.2736 ± 1.0283 | -0.1092 ± 0.73776 |
| Week 24, n= 224, 209 | -0.3098 ± 1.11093 | -0.1922 ± 0.79848 |
| Week 36, n= 212, 198 | -0.3286 ± 1.01181 | -0.1433 ± 0.79498 |
| Week 48, n= 207, 186 | -0.2886 ± 1.01415 | -0.1444 ± 1.23362 |
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| 10^9 cells per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Basophils, Week 4, n= 241, 234 | 0.003 ± 0.0182 | 0.003 ± 0.0198 |
| Basophils, Week 12, n= 228, 216 | 0.002 ± 0.0174 | 0.003 ± 0.0162 |
| Basophils, Week 24, n= 221, 208 | 0.004 ± 0.0187 | 0.003 ± 0.0155 |
| Basophils, Week 36, n= 214, 203 | 0.004 ± 0.0182 | 0.003 ± 0.0158 |
| Basophils, Week 48, n= 206, 189 | 0.005 ± 0.0199 | 0.006 ± 0.0146 |
| Eosinophils, Week 4, n= 241, 234 | 0.040 ± 0.1486 | 0.021 ± 0.1648 |
| Eosinophils, Week 12, n= 228, 216 | 0.037 ± 0.1982 | -0.001 ± 0.1610 |
| Eosinophils, Week 24, n= 221, 208 | 0.028 ± 0.1927 | 0.005 ± 0.1973 |
| Eosinophils, Week 36, n= 214, 203 | 0.048 ± 0.2244 | 0.014 ± 0.2139 |
| Eosinophils, Week 48, n= 206, 189 | 0.030 ± 0.1744 | 0.007 ± 0.2274 |
| Lymphocytes, Week 4, n= 241, 234 | 0.208 ± 0.4914 | 0.119 ± 0.5493 |
| Lymphocytes, Week 12, n= 228, 216 | 0.257 ± 0.5500 | 0.156 ± 0.6690 |
| Lymphocytes, Week 24, n= 221, 208 | 0.317 ± 0.4889 | 0.192 ± 0.5910 |
| Lymphocytes, Week 36, n= 214, 203 | 0.362 ± 0.5199 | 0.178 ± 0.6441 |
| Lymphocytes, Week 48, n= 206, 189 | 0.359 ± 0.5235 | 0.261 ± 0.7098 |
| Monocytes, Week 4, n= 241, 234 | -0.001 ± 0.1558 | -0.015 ± 0.1391 |
| Monocytes, Week 12, n= 228, 216 | -0.010 ± 0.1412 | -0.031 ± 0.1369 |
| Monocytes, Week 24, n= 221, 208 | 0.008 ± 0.1498 | -0.015 ± 0.1581 |
| Monocytes, Week 36, n= 214, 203 | -0.006 ± 0.1448 | -0.028 ± 0.1500 |
| Monocytes, Week 48, n= 206, 189 | 0.001 ± 0.1379 | -0.024 ± 0.1638 |
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| 10^12 cells per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 4, n= 243, 234 | -0.04 ± 0.244 | -0.07 ± 0.239 |
| Week 12, n= 233, 220 | -0.07 ± 0.351 | -0.09 ± 0.308 |
| Week 24, n= 225, 211 | -0.08 ± 0.373 | -0.09 ± 0.329 |
| Week 36, n= 218, 203 | -0.10 ± 0.384 | -0.08 ± 0.358 |
| Week 48, n= 207, 190 | -0.10 ± 0.365 | -0.05 ± 0.318 |
Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Proportion of red blood cells in blood | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 4, n= 243, 234 | 0.0003 ± 0.02176 | -0.0042 ± 0.02238 |
| Week 12, n= 233, 220 | 0.0081 ± 0.03157 | 0.0000 ± 0.02646 |
| Week 24, n= 225, 211 | 0.0157 ± 0.03209 | 0.0051 ± 0.03083 |
| Week 36, n= 218, 203 | 0.0167 ± 0.03451 | 0.0062 ± 0.03379 |
| Week 48, n= 207, 190 | 0.0212 ± 0.03293 | 0.0107 ± 0.03200 |
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Femtoliter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 4, n= 243, 234 | 0.9 ± 1.81 | 0.5 ± 1.83 |
| Week 12, n= 233, 220 | 3.4 ± 2.98 | 1.9 ± 2.94 |
| Week 24, n= 225, 211 | 5.5 ± 4.03 | 3.1 ± 4.33 |
| Week 36, n= 218, 203 | 6.0 ± 4.04 | 3.1 ± 5.22 |
| Week 48, n= 207, 190 | 7.1 ± 4.31 | 3.7 ± 5.15 |
Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
| Millimoles per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Change From Baseline in Triglycerides at Week 48 | 0.045 ± 0.0477 | 0.070 ± 0.0477 |
Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
| Ratio | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Change From Baseline in TC/HDL Ratio at Week 48 | -0.264 ± 0.0707 | -0.158 ± 0.0784 |
Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| milligrams per millimole | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 24, n= 179, 186 | -1.15 ± 16.557 | -1.03 ± 9.091 |
| Week 48, n= 170, 164 | -0.68 ± 20.597 | -0.10 ± 9.393 |
Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Grade 1 | 79 | 60 |
| Grade 2 | 94 | 91 |
| Grade 3 | 18 | 37 |
| Grade 4 | 3 | 9 |
Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|
| Grade 1 | 32 |
| Grade 2 | 48 |
| Grade 3 | 7 |
| Grade 4 | 6 |
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is 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, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Any AEs | 195 | 197 |
| Any SAEs | 12 | 20 |
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is 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, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|
| Any AEs | 93 |
| Any SAEs | 13 |
Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Hyperglycaemia, Grade 1 | 17 | 11 |
| Hyperglycaemia, Grade 2 | 16 | 9 |
| Hyperglycaemia, Grade 3 | 4 | 3 |
| Hyperglycaemia, Grade 4 | 1 | 0 |
| Hyperkalemia, Grade 1 | 1 | 0 |
| Hyperkalemia, Grade 2 | 0 | 1 |
| Hyperkalemia, Grade 3 | 0 | 0 |
| Hyperkalemia, Grade 4 | 0 | 0 |
| Hypernatremia, Grade 1 | 1 | 0 |
| Hypernatremia, Grade 2 | 0 | 0 |
| Hypernatremia, Grade 3 | 0 | 0 |
| Hypernatremia, Grade 4 | 0 | 0 |
| Hypoglycaemia, Grade 1 | 6 | 5 |
| Hypoglycaemia, Grade 2 | 3 | 1 |
| Hypoglycaemia, Grade 3 | 1 | 0 |
| Hypoglycaemia, Grade 4 | 0 | 0 |
| Hypokalemia, Grade 1 | 17 | 19 |
| Hypokalemia, Grade 2 | 1 | 0 |
| Hypokalemia, Grade 3 | 0 | 0 |
| Hypokalemia, Grade 4 | 0 | 0 |
| Hyponatremia, Grade 1 | 44 | 57 |
| Hyponatremia, Grade 2 | 1 | 0 |
| Hyponatremia, Grade 3 | 0 | 0 |
| Hyponatremia, Grade 4 | 0 | 0 |
| Alanine aminotransferase, Grade 1 | 5 | 7 |
| Alanine aminotransferase, Grade 2 | 6 | 4 |
| Alanine aminotransferase, Grade 3 | 1 | 2 |
| Alanine aminotransferase, Grade 4 | 1 | 0 |
| Albumin, Grade 1 | 3 | 2 |
| Albumin, Grade 2 | 0 | 2 |
| Albumin, Grade 3 | 0 | 0 |
| Albumin, Grade 4 | 0 | 0 |
| Alkaline phosphatase, Grade 1 | 3 | 14 |
| Alkaline phosphatase, Grade 2 | 2 | 1 |
| Alkaline phosphatase, Grade 3 | 0 | 0 |
| Alkaline phosphatase, Grade 4 | 0 | 0 |
| Aspartate aminotransferase, Grade 1 | 12 | 7 |
| Aspartate aminotransferase, Grade 2 | 4 | 4 |
| Aspartate aminotransferase, Grade 3 | 1 | 2 |
| Aspartate aminotransferase, Grade 4 | 1 | 0 |
| Bilirubin, Grade 1 | 2 | 52 |
| Bilirubin, Grade 2 | 0 | 86 |
| Bilirubin, Grade 3 | 0 | 57 |
| Bilirubin, Grade 4 | 0 | 5 |
| Carbon dioxide, Grade 1 | 65 | 54 |
| Carbon dioxide, Grade 2 | 4 | 3 |
| Carbon dioxide, Grade 3 | 0 | 0 |
| Carbon dioxide, Grade 4 | 0 | 0 |
| Cholesterol, Grade 1 | 52 | 31 |
| Cholesterol, Grade 2 | 28 | 9 |
| Cholesterol, Grade 3 | 4 | 2 |
| Cholesterol, Grade 4 | 0 | 0 |
| Creatine kinase, Grade 1 | 3 | 5 |
| Creatine kinase, Grade 2 | 1 | 1 |
| Creatine kinase, Grade 3 | 3 | 0 |
| Creatine kinase, Grade 4 | 0 | 1 |
| Creatinine, Grade 1 | 3 | 7 |
| Creatinine, Grade 2 | 0 | 3 |
| Creatinine, Grade 3 | 1 | 0 |
| Creatinine, Grade 4 | 0 | 0 |
| LDL cholesterol calculation, Grade 1 | 38 | 21 |
| LDL cholesterol calculation, Grade 2 | 13 | 9 |
| LDL cholesterol calculation, Grade 3 | 7 | 2 |
| LDL cholesterol calculation, Grade 4 | 0 | 0 |
| LDL cholesterol direct, Grade 1 | 3 | 1 |
| LDL cholesterol direct, Grade 2 | 1 | 0 |
| LDL cholesterol direct, Grade 3 | 0 | 0 |
| LDL cholesterol direct, Grade 4 | 0 | 0 |
| Lipase, Grade 1 | 12 | 7 |
| Lipase, Grade 2 | 5 | 3 |
| Lipase, Grade 3 | 3 | 2 |
| Lipase, Grade 4 | 0 | 1 |
| Phosphate, Grade 1 | 5 | 11 |
| Phosphate, Grade 2 | 7 | 9 |
| Phosphate, Grade 3 | 1 | 2 |
| Phosphate, Grade 4 | 0 | 0 |
| Potassium, Grade 1 | 18 | 19 |
| Potassium, Grade 2 | 1 | 1 |
| Potassium, Grade 3 | 0 | 0 |
| Potassium, Grade 4 | 0 | 0 |
| Sodium, Grade 1 | 45 | 57 |
| Sodium, Grade 2 | 1 | 0 |
| Sodium, Grade 3 | 0 | 0 |
| Sodium, Grade 4 | 0 | 0 |
| Triglycerides, Grade 1 | 0 | 0 |
| Triglycerides, Grade 2 | 5 | 2 |
| Triglycerides, Grade 3 | 2 | 0 |
| Triglycerides, Grade 4 | 0 | 0 |
| Glucose, Grade 1 | 22 | 15 |
| Glucose, Grade 2 | 19 | 10 |
| Glucose, Grade 3 | 4 | 3 |
| Glucose, Grade 4 | 1 | 0 |
Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|
| Hyperglycaemia, Grade 1, n=143 | 24 |
| Hyperglycaemia, Grade 2, n=143 | 9 |
| Hyperglycaemia, Grade 3, n=143 | 3 |
| Hyperglycaemia, Grade 4, n=143 | 0 |
| Hypernatremia, Grade 1, n=146 | 2 |
| Hypernatremia, Grade 2, n=146 | 0 |
| Hypernatremia, Grade 3, n=146 | 0 |
| Hypernatremia, Grade 4, n=146 | 0 |
| Hypoglycaemia, Grade 1, n=143 | 1 |
| Hypoglycaemia, Grade 2, n=143 | 0 |
| Hypoglycaemia, Grade 3, n=143 | 0 |
| Hypoglycaemia, Grade 4, n=143 | 1 |
| Hypokalemia, Grade 1, n=146 | 13 |
| Hypokalemia, Grade 2, n=146 | 0 |
| Hypokalemia, Grade 3, n=146 | 0 |
| Hypokalemia, Grade 4, n=146 | 0 |
| Hyponatremia, Grade 1, n=146 | 36 |
| Hyponatremia, Grade 2, n=146 | 0 |
| Hyponatremia, Grade 3, n=146 | 0 |
| Hyponatremia, Grade 4, n=146 | 0 |
| Alanine aminotransferase, Grade 1, n=146 | 7 |
| Alanine aminotransferase, Grade 2, n=146 | 3 |
| Alanine aminotransferase, Grade 3, n=146 | 0 |
| Alanine aminotransferase, Grade 4, n=146 | 2 |
| Alkaline phosphatase, Grade 1, n=146 | 5 |
| Alkaline phosphatase, Grade 2, n=146 | 0 |
| Alkaline phosphatase, Grade 3, n=146 | 0 |
| Alkaline phosphatase, Grade 4, n=146 | 0 |
| Aspartate aminotransferase, Grade 1, n=146 | 10 |
| Aspartate aminotransferase, Grade 2, n=146 | 2 |
| Aspartate aminotransferase, Grade 3, n=146 | 0 |
| Aspartate aminotransferase, Grade 4, n=146 | 2 |
| Bilirubin, Grade 1, n=146 | 4 |
| Bilirubin, Grade 2, n=146 | 1 |
| Bilirubin, Grade 3, n=146 | 3 |
| Bilirubin, Grade 4, n=146 | 0 |
| Carbon dioxide, Grade 1, n=146 | 58 |
| Carbon dioxide, Grade 2, n=146 | 7 |
| Carbon dioxide, Grade 3, n=146 | 0 |
| Carbon dioxide, Grade 4, n=146 | 0 |
| Cholesterol, Grade 1, n=71 | 9 |
| Cholesterol, Grade 2, n=71 | 9 |
| Cholesterol, Grade 3, n=71 | 3 |
| Cholesterol, Grade 4, n=71 | 0 |
| Creatine kinase, Grade 1, n=146 | 6 |
| Creatine kinase, Grade 2, n=146 | 1 |
| Creatine kinase, Grade 3, n=146 | 1 |
| Creatine kinase, Grade 4, n=146 | 1 |
| Creatinine, Grade 1, n=146 | 5 |
| Creatinine, Grade 2, n=146 | 0 |
| Creatinine, Grade 3, n=146 | 0 |
| Creatinine, Grade 4, n=146 | 1 |
| LDL cholesterol calculation, Grade 1, n=70 | 5 |
| LDL cholesterol calculation, Grade 2, n=70 | 8 |
| LDL cholesterol calculation, Grade 3, n=70 | 2 |
| LDL cholesterol calculation, Grade 4, n=70 | 0 |
| LDL cholesterol direct, Grade 1, n=2 | 1 |
| LDL cholesterol direct, Grade 2, n=2 | 0 |
| LDL cholesterol direct, Grade 3, n=2 | 0 |
| LDL cholesterol direct, Grade 4, n=2 | 0 |
| Lipase, Grade 1, n=146 | 9 |
| Lipase, Grade 2, n=146 | 6 |
| Lipase, Grade 3, n=146 | 1 |
| Lipase, Grade 4, n=146 | 1 |
| Phosphate, Grade 1, n=146 | 2 |
| Phosphate, Grade 2, n=146 | 15 |
| Phosphate, Grade 3, n=146 | 2 |
| Phosphate, Grade 4, n=146 | 0 |
| Potassium, Grade 1, n=146 | 13 |
| Potassium, Grade 2, n=146 | 0 |
| Potassium, Grade 3, n=146 | 0 |
| Potassium, Grade 4, n=146 | 0 |
| Sodium, Grade 1, n=146 | 37 |
| Sodium, Grade 2, n=146 | 0 |
| Sodium, Grade 3, n=146 | 0 |
| Sodium, Grade 4, n=146 | 0 |
| Triglycerides, Grade 1, n=71 | 0 |
| Triglycerides, Grade 2, n=71 | 1 |
| Triglycerides, Grade 3, n=71 | 0 |
| Triglycerides, Grade 4, n=71 | 0 |
| Glucose, Grade 1, n=143 | 24 |
| Glucose, Grade 2, n=143 | 9 |
| Glucose, Grade 3, n=143 | 3 |
| Glucose, Grade 4, n=143 | 1 |
Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Hemoglobin, Grade 1 | 7 | 21 |
| Hemoglobin, Grade 2 | 2 | 3 |
| Hemoglobin, Grade 3 | 1 | 1 |
| Hemoglobin, Grade 4 | 0 | 0 |
| Leukocytes, Grade 1 | 5 | 6 |
| Leukocytes, Grade 2 | 1 | 2 |
| Leukocytes, Grade 3 | 0 | 0 |
| Leukocytes, Grade 4 | 0 | 0 |
| Neutrophils, Grade 1 | 15 | 12 |
| Neutrophils, Grade 2 | 7 | 9 |
| Neutrophils, Grade 3 | 0 | 2 |
| Neutrophils, Grade 4 | 1 | 1 |
| Platelets, Grade 1 | 6 | 1 |
| Platelets, Grade 2 | 0 | 2 |
| Platelets, Grade 3 | 1 | 0 |
| Platelets, Grade 4 | 0 | 0 |
Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|
| Hemoglobin, Grade 1 | 5 |
| Hemoglobin, Grade 2 | 1 |
| Hemoglobin, Grade 3 | 0 |
| Hemoglobin, Grade 4 | 0 |
| Leukocytes, Grade 1 | 2 |
| Leukocytes, Grade 2 | 0 |
| Leukocytes, Grade 3 | 1 |
| Leukocytes, Grade 4 | 0 |
| Neutrophils, Grade 1 | 10 |
| Neutrophils, Grade 2 | 2 |
| Neutrophils, Grade 3 | 1 |
| Neutrophils, Grade 4 | 1 |
| Platelets, Grade 1 | 3 |
| Platelets, Grade 2 | 1 |
| Platelets, Grade 3 | 0 |
| Platelets, Grade 4 | 0 |
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. 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, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase | 10 | 17 |
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. 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, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|
| Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase | 4 |
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Micrograms per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| BSAP, Week 24, n=219, 207 | 1.33 ± 3.934 | 6.00 ± 5.962 |
| BSAP, Week 48, n=202, 184 | 2.64 ± 5.746 | 7.60 ± 7.144 |
| Osteocalcin, Week 24, n=209, 197 | 3.73 ± 7.484 | 14.38 ± 22.205 |
| Osteocalcin, Week 48, n=194, 178 | 5.15 ± 9.018 | 16.30 ± 25.043 |
| PTP, Week 24, n=223, 206 | 10.1 ± 20.11 | 32.0 ± 27.89 |
| PTP, Week 48, n=205, 186 | 11.2 ± 23.05 | 34.1 ± 27.28 |
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Nanograms per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 24, n=221, 207 | 89.8 ± 173.09 | 272.4 ± 205.22 |
| Week 48, n=202, 185 | 75.9 ± 173.73 | 267.9 ± 200.82 |
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Nanomoles per liter | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Vitamin D, Week 24, n=223, 208 | 1.8 ± 24.95 | 16.3 ± 31.66 |
| Vitamin D, Week 48, n=206, 186 | -1.9 ± 20.63 | 8.9 ± 23.78 |
| Vitamin D2, Week 24, n=223, 208 | 0.3 ± 6.04 | 1.0 ± 7.88 |
| Vitamin D2, Week 48, n=206, 186 | 0.1 ± 4.71 | 0.9 ± 11.00 |
| Vitamin D3, Week 24, n=223, 208 | 1.5 ± 24.33 | 15.2 ± 31.39 |
| Vitamin D3, Week 48, n=206, 186 | -1.9 ± 20.56 | 7.9 ± 21.72 |
Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.
| Ratio | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| BSAP, n=202, 183 | 1.188 (1.135 to 1.243) | 1.629 (1.553 to 1.708) |
| PTP, n=202, 184 | 1.214 (1.158 to 1.272) | 1.752 (1.668 to 1.840) |
| Osteocalcin, n=194, 178 | 1.282 (1.214 to 1.354) | 2.039 (1.926 to 2.159) |
| Type 1 Collagen C-Telopeptide, n=202, 184 | 1.257 (1.195 to 1.323) | 1.918 (1.819 to 2.023) |
| Vitamin D, n=206, 186 | 0.987 (0.940 to 1.036) | 1.158 (1.101 to 1.219) |
The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
| Score on a scale | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Total Score, Week 48, n=205, 192 | 0.0 ± 5.15 | 0.1 ± 5.66 |
| MCS, Week 48, n=205, 192 | 2.397 ± 10.5232 | 2.329 ± 9.9782 |
| PCS, Week 48, n=205, 192 | 1.905 ± 8.6309 | 1.444 ± 8.3938 |
The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test.
| Score on a scale | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Week 4, n=243, 239 | 54.0 ± 6.37 | 51.9 ± 8.53 |
| Week 12, n=236, 226 | 56.1 ± 5.38 | 53.6 ± 7.67 |
| Week 24, n=225, 211 | 56.8 ± 4.55 | 54.3 ± 7.27 |
| Week 48, n=206, 191 | 57.0 ± 4.38 | 55.4 ± 6.00 |
Percentage of participants with plasma HIV-1 RNA \<50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA \[BPHR\], Baseline CD4+ cell count \[BCCC\], Baseline Centers for Disease Control and Prevention \[CDC\] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =\<versus \[vs\]. \>100,000 c/mL) and CD4+ cell count (=\<350 cells/mm\^3 or \>350 cells/mm\^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off.
| Percentage of participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| Age, <50 Years, n=212, 212 | 80 | 71 |
| Age, >=50 Years, n=36, 35 | 92 | 74 |
| Race, White, n=115, 107 | 86 | 80 |
| Race, Non-White, n=133,140 | 78 | 64 |
| Race, African-American/African Heritage, n=102,108 | 74 | 67 |
| Non-African-American/African Heritage, n=146, 139 | 88 | 75 |
| BPHR, <1000, n=5, 10 | 60 | 80 |
| BPHR, 1000 to <10,000, n=66, 62 | 83 | 77 |
| BPHR, 10,000 to <50,000, n=83, 81 | 84 | 74 |
| BPHR, 50,000 to <=100,000, n=25, 28 | 80 | 64 |
| BPHR, >100,000, n=69, 66 | 80 | 64 |
| BCCC, <200, n=64, 49 | 81 | 69 |
| BCCC, >=200, n=184, 198 | 82 | 72 |
| BCCC, <50, n=9, 15 | 67 | 60 |
| BCCC, 50 to <200, n=55, 34 | 84 | 74 |
| BCCC, 200 to <350, n=66, 74 | 89 | 73 |
| BCCC, 350 to <500, n=56, 65 | 79 | 74 |
| BCCC, >=500, n=62, 59 | 77 | 68 |
| CDC category, A, n=210, 208 | 81 | 71 |
| CDC category, B, n=27, 30 | 81 | 77 |
| CDC category, C, n=11, 9 | 91 | 56 |
| HIV-1 subtype: B vs Non-B, B, n=95, 111 | 80 | 69 |
| HIV-1 subtype: B vs Non-B, non-B, n=140, 131 | 84 | 73 |
| Argentina, n=24, 20 | 92 | 80 |
| Canada, n=11, 9 | 91 | 89 |
| France, n=7, 8 | 100 | 75 |
| Italy, n=17, 11 | 88 | 64 |
| Mexico, n=6, 5 | 100 | 60 |
| Portugal, n=4, 5 | 75 | 60 |
| Puerto Rico, n=0, 2 | — | 100 |
| Russia, n=28, 22 | 89 | 82 |
| South Africa, n=33, 33 | 67 | 76 |
| Spain, n=23, 31 | 70 | 77 |
| Thailand, n=19, 21 | 95 | 52 |
| USA, n=62, 69 | 74 | 67 |
| United Kingdom, n=14, 11 | 93 | 64 |
Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase |
|---|---|---|
| CDC Class A to CDC Class C | 5 | 4 |
| CDC Class B to CDC Class C | 1 | 2 |
| CDC Class C to new CDC Class C | 0 | 0 |
| CDC Class A, B or C to Death | 1 | 1 |
Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD |
|---|---|
| CDC Class A to CDC Class C | 6 |
| CDC Class B to CDC Class C | 1 |
| CDC Class C to new CDC Class C | 0 |
| CDC Class A, B or C to Death | 2 |
Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.
| Participants | DTG 50 mg/ABC 600 mg/3TC 300 mg QD |
|---|---|
| INSTI; n= 6 | 0 |
| NNRTI; n=8 | 1 |
| NRTI; n=8 | 1 |
| PI; n=8 | 0 |
Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.
| Participants | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD-Randomized Phase |
|---|---|
| INSTI; n= 3 | 1 |
| NNRTI; n=4 | 0 |
| NRTI; n=4 | 1 |
| PI; n=4 | 0 |
Collected over All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 48 for Randomized Phase; from Weeks 48 to 432 for Continuation Phase. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 1/248 (0.4%) | 12/248 (4.8%) | 138/248 (55.6%) |
| ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0/247 (0%) | 20/247 (8.1%) | 164/247 (66.4%) |
| DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 1/149 (0.7%) | 13/149 (8.7%) | 30/149 (20.1%) |
| Event | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/248 | 2/247 | 2/149 |
| PeritonitisInfections and infestations | 0/248 | 0/247 | 2/149 |
| PneumoniaInfections and infestations | 1/248 | 2/247 | 0/149 |
| MalariaInfections and infestations | 0/248 | 0/247 | 1/149 |
| MastoiditisInfections and infestations | 0/248 | 0/247 | 1/149 |
| Otitis media chronicInfections and infestations | 0/248 | 0/247 | 1/149 |
| Toxicity to various agentsInjury, poisoning and procedural complications | 0/248 | 0/247 | 1/149 |
| Acute hepatitis CInfections and infestations | 0/248 | 0/247 | 1/149 |
| SepsisInfections and infestations | 0/248 | 0/247 | 1/149 |
| Ischaemic strokeNervous system disorders | 0/248 | 0/247 | 1/149 |
| Event | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase |
|---|---|---|---|
| NauseaGastrointestinal disorders | 46/248 | 49/247 | 0/149 |
| DiarrhoeaGastrointestinal disorders | 23/248 | 32/247 | 8/149 |
| HeadacheNervous system disorders | 29/248 | 32/247 | 12/149 |
| CoughRespiratory, thoracic and mediastinal disorders | 10/248 | 26/247 | 0/149 |
| DyspepsiaGastrointestinal disorders | 9/248 | 25/247 | 0/149 |
| Upper respiratory tract infectionInfections and infestations | 18/248 | 21/247 | 13/149 |
| RashSkin and subcutaneous tissue disorders | 13/248 | 21/247 | 0/149 |
| VomitingGastrointestinal disorders | 15/248 | 18/247 | 0/149 |
| Back painMusculoskeletal and connective tissue disorders | 12/248 | 18/247 | 0/149 |
| Ocular icterusHepatobiliary disorders | 0/248 | 18/247 | 0/149 |
Baseline Characteristic data are reported for members of the ITT-E Population which comprised of all randomized participants who received at least one dose of study treatment.
| Age, Continuous(Years) | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Total |
|---|---|---|---|
| Mean | 38.1 ± 11.15 | 37.8 ± 10.14 | 37.9 ± 10.65 |
| Sex: Female, Male(Participants) | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Total |
|---|---|---|---|
| Female | 248 | 247 | 495 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | Total |
|---|---|---|---|
| African American/African Heritage | 102 | 108 | 210 |
| American Indian Or Alaskan Native | 6 | 7 | 13 |
| Asian - Central/South Asian Heritage | 2 | 0 | 2 |
| Asian - East Asian Heritage | 0 | 1 | 1 |
| Asian - South East Asian Heritage | 20 | 22 | 42 |
| Native Hawaiian Or Other Pacific Islander | 1 | 0 | 1 |
| White - Arabic/North African Heritage | 3 | 3 | 6 |
| White - White/Caucasian/European Heritage | 112 | 104 | 216 |
| Mixed Race | 2 | 2 | 4 |
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Plan to share: 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 ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/
Supporting information: Study protocol, Sap, Icf, Csr
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