Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Plasma Trough Concentration (Ctrough) for CAB LA |
Blood samples were collected at indicated time points for pharmacokinetic analysis of CAB LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary population pharmacokinetic (Pop PK) analyses were not conducted. |
Pre-dose (Day 1) and Month 12 |
|
Other |
Ctrough for RPV LA |
Blood samples were collected at indicated time points for pharmacokinetic analysis of RPV LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary Pop PK analyses were not conducted. |
Pre-dose (Day 1) and Month 12 |
|
Primary |
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 |
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. Intent-to-treat-Exposed (ITT-E) Population comprised of all participants who received at least one dose of investigational product (IP) during on or after Day 1 visit. Participants were analyzed according to the selected treatment regardless of what treatment was actually received. |
Month 12 |
|
Secondary |
Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12 |
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. |
Month 12 |
|
Secondary |
Percentage of Participants With Protocol-defined Confirmed Virologic Failure Overtime |
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. |
Up to Month 12 |
|
Secondary |
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12 |
|
Secondary |
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12 |
|
Secondary |
Absolute Values for HIV-1 RNA of DTG + RPV Arm |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12 |
|
Secondary |
Change From Baseline in HIV-1 RNA for DTG + RPV Arm |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 6, 8, and 12 |
|
Secondary |
Absolute Values for CD4+ for DTG + RPV Arm |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 6, 8, and 12 |
|
Secondary |
Change From Baseline Values for CD4+ for DTG + RPV Arm |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) |
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. Safety Population comprised of all participants who received at least one dose of study treatment on or after Day 1 visit. Participants were assessed according to actual treatment received. |
Up to Month 17 |
|
Secondary |
Number of Participants With Severity of Adverse Events |
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). |
Up to Month 17 |
|
Secondary |
Number of Participants With Maximum Post-Baseline Chemistry Toxicities |
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 aminotranferase (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). |
Up to Month 12 |
|
Secondary |
Number of Participants With Maximum Post-Baseline Hematology Toxicities |
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 following hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). |
Up to Month 12 |
|
Secondary |
Percentage of Participants Who Permanently Discontinued Treatment Due to Adverse Events |
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. Percentage of participants with adverse events leading to permanent withdrawal has been presented. |
Up to Month 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase Over Time for CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time for DTG + RPV Arm |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time for CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time for DTG+ RPV Arm |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine Over Time for CAB LA + RPV LA Q2M Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine Over Time for DTG+ RPV Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time for CAB LA + RPV LA Q2M Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time for DTG + RPV Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein (HDL) Cholesterol Direct, Low Density Lipoprotein (LDL) Cholesterol Calculation, LDL Cholesterol Direct and Triglycerides for CAB LA + RPV LA Q2M Arm |
Blood samples were collected for the analysis of clinical chemical parameters: cholesterol, direct HDL cholesterol, LDL cholesterol calculation, direct LDL 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. |
Baseline (Day 1) and at Month 12 |
|
Secondary |
Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm |
Blood samples were collected for the analysis of clinical chemical parameters: cholesterol, HDL cholesterol direct, LDL cholesterol calculation, LDL cholesterol direct and triglycerides. |
At Day 1 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Month 12 |
|
Secondary |
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for DTG + RPV Arm |
Blood samples were collected for the analysis of clinical chemical 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. |
Baseline (Day 1) and at Month 6 |
|
Secondary |
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm |
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. |
Baseline (Day 1) and at Months 2, 4, 8 and 12 |
|
Secondary |
Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm |
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. |
Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
Secondary |
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. |
At Day 1 |
|
Secondary |
Absolute Values of Urine Creatinine |
Urine samples were collected for the analysis of urine creatinine. |
At Day 1 |
|
Secondary |
Absolute Values of Urine Phosphate |
Urine samples were collected for the analysis of urine phosphate. |
At Day 1 |
|
Secondary |
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. |
At Day 1 |
|
Secondary |
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). |
At Day 1 |
|
Secondary |
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. |
Up to Month 12 |
|
Secondary |
Number of Participants With Treatment Emergent Phenotypic Resistance |
Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. |
Up to Month 12 |
|
Secondary |
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 was calculated for 26 individual domain items by multiplying impact score (-3[maximum negative impact] to +1[maximum 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 impact scores and dividing by the number of domain items. The ranges of weighted impact score and average impact score were from -9(maximum negative impact) to +3(maximum positive impact); 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). |
Baseline (Day 1) and at Months 6 and 12 |
|
Secondary |
Change From Baseline in 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; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. 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. 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. |
Baseline (Day 1) and at Months 6 and 12 |
|
Secondary |
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. |
Baseline (Day 1) and at Months 6 and 12 |
|
Secondary |
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 should not be computed and remain missing. |
At Month 12 |
|