This study (POLAR), is designed to assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral therapy (ART) experienced participants. Participants will rollover from the NCT01641809 (LATTE) study, who have completed minimum duration of Week 312 and with demonstrated HIV-1 ribonucleic acid (RNA) suppression (less than \[\<\]50 copies (c) per milliliter \[mL\]), while receiving a two-drug regimen consisting of once-daily oral CAB at 30 milligram (mg) plus RPV at 25 mg. The participants will be offered the option to switch to the LA, intramuscular injections of CAB LA plus RPV LA, Q2M or the oral fixed dose combination (FDC) of dolutegravir (DTG) plus RPV, for the continued maintenance of HIV-1 RNA suppression, known as the Maintenance Phase (From Day 1 to Commercial Approval). Duration of study will vary from country to country, until regimen receives regulatory approval and becomes commercially available. The study plans to enroll approximately 100 participants. Any participant who receives at least one dose of CAB LA and/or RPV LA and discontinues the CAB LA plus RPV LA regimen for any reason will enter a 52-week Long-Term Follow-Up (LTFU) phase. Those participants must remain on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and or RPV LA.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Administered CAB LA (600 mg) Q2M, as intramuscular injection.
Administered RPV LA (900 mg), Q2M, as intramuscular injection.
Oral dose of RPV 25 mg, administered once daily from Day 1 up to Month 12
Oral dose of DTG 50 mg administered once daily from Day 1 up to Month 12.
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Bakersfield, California, United States
GSK Investigational Site
Beverly Hills, California, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Los Angeles, California, United States
Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12 [Maintenance Phase]
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and DTG + RPV regimen in HIV-1 infected antiretroviral therapy (ART) experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window.
Time frame: At Month 12 [Maintenance Phase]
Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12 [Maintenance Phase]
Percentage of participants with HIV-1 RNA \<50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and oral DTG + RPV regimen. The HIV-1 RNA \<50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window.
Time frame: At Month 12 [Maintenance Phase]
Number of Participants With Protocol-defined Confirmed Virologic Failure up to End of Maintenance Phase
Confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 c/mL after prior suppression to \<200 c/mL.
Time frame: Up to End of Maintenance Phase (up to Month 52 for CAB LA+RPV LA Q2M group, up to Month 12 for DTG+RPV group)
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase]
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12 [Maintenance Phase]
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase]
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of DTG + RPV regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Standard Deviation (SD)=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
Time frame: From Baseline (Day 1) up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
Time frame: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: From Baseline (Day 1) up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for CAB LA + RPV LA Q2M Arm
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.
Time frame: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for DTG + RPV Arm
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.
Time frame: Up to Month 12 [Maintenance Phase]
Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm
Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).
Time frame: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Number of Participants With Severity of Adverse Events for DTG + RPV Arm
Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).
Time frame: Up to Month 12 [Maintenance Phase]
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase
Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time frame: Up to End of Maintenance Phase (up to Month 52)
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time frame: Up to Month 12 [Maintenance Phase]
Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase
The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of the hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time frame: Up to End of Maintenance Phase (up to Month 52)
Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase]
The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of the hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time frame: Up to Month 12 [Maintenance Phase]
Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants with adverse events leading to permanent withdrawal has been presented.
Time frame: Up to End of Maintenance Phase (up to Month 52)
Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for DTG + RPV Arm up to Month 12 [Maintenance Phase]
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants with adverse events leading to permanent withdrawal has been presented.
Time frame: Up to Month 12 [Maintenance Phase]
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase
Blood samples were collected for the analysis of clinical chemical parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. SD=0.00(0) is defined as SD resulted below the detectable limit of the assay and approximate to 0.00(0).
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, direct high density lipoprotein cholesterol, LDL cholesterol calculation, direct low density lipoprotein cholesterol and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline
Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, HDL cholesterol direct, LDL cholesterol calculation, LDL cholesterol direct and triglycerides.
Time frame: At Baseline (Day 1)
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for DTG + RPV Arm at Month 6 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Month 6 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio
Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.
Time frame: At Baseline (Day 1)
Absolute Values of Urine Creatinine
Urine samples were collected for the analysis of urine creatinine.
Time frame: At Baseline (Day 1)
Absolute Values of Urine Phosphate
Urine samples were collected for the analysis of urine phosphate.
Time frame: At Baseline (Day 1)
Absolute Values of Urine Specific Gravity
Urine samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.
Time frame: At Baseline (Day 1)
Absolute Values of Urine Potential of Hydrogen (pH)
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Time frame: At Baseline (Day 1)
Number of Participants With Treatment Emergent Genotypic Resistance
Plasma samples were collected and analyzed for genotypic resistance from participants who met confirmed virologic withdrawal criteria.
Time frame: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Number of Participants With Treatment Emergent Phenotypic Resistance
Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.
Time frame: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV)
HIVDQoL includes 2 overview items and 26 domain items. The 2 overview items: Item 1: 3(excellent) to -3(extremely bad); Higher score indicates better quality of life. Item 2: -3(very much better) to 1(worse); Lower score indicates better quality of life. The Weighted Impact Score (WIS) was calculated for the 26 domain items by multiplying impact score(IS) (-3\[maximum {max.} negative impact\] to +1\[max. positive impact\] by the corresponding importance score (3 \[very important\] to 0\[not all important\]). Average Weighted Impact (AWI) score was calculated by summing individual weighted IS and dividing by the number of domain items. The ranges of WIS and average IS were from -9(max. negative) to +3(max. positive);higher score indicates positive impact. Change from Baseline was defined as post-dose visit value minus Baseline value (latest pre-treatment assessment with a non-missing value). SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.
Time frame: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Total Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)
HIVTSQs total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment as compared to the past few weeks; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change From Baseline in Individual Item Score of HIVTSQs
HIVTSQs is a 12 item questionnaire. The individual item scores are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. Change from Baseline is defined as post-dose value minus Baseline value. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.
Time frame: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Change in Treatment Satisfaction Over Time Using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc)
HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores represented deterioration in satisfaction with treatment. A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores were imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score was not computed and remained missing.
Time frame: At Month 12 (compared with Baseline [Day 1]) [Maintenance Phase]
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GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Washington D.C., District of Columbia, United States
GSK Investigational Site
Fort Lauderdale, Florida, United States
GSK Investigational Site
Ft. Pierce, Florida, United States
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