Primary Outcome Measures: | |
1. |
Percentage of participants with plasma human immunodeficiency virus (HIV)-1 ribonucleic acid (RNA) greater than or equal to (>=) 50 copies per mL (c/mL) - OLI [ Time Frame: At Month 12 ]
Participants with plasma HIV-1 RNA >=50 c/mL per Food and Drug Administration (FDA) snapshot algorithm will be assessed. |
2. |
Percentage of participants with plasma HIV-1 RNA >=50 c/mL - D2I [ Time Frame: At Month 11 ]
Participants with plasma HIV-1 RNA >=50 c/mL per FDA snapshot algorithm will be assessed. |
3. |
Percentage of participants with plasma HIV-1 RNA >=50 c/mL - BIK [ Time Frame: At Month 12 ]
Participants with plasma HIV-1 RNA >=50 c/mL per FDA snapshot algorithm will be assessed. |
Secondary Outcome Measures: | |
1. |
Percentage of participants with plasma HIV-1 RNA less than (<)50 c/mL - OLI [ Time Frame: At Months 6 and 12 ]
Participants with plasma HIV-1 RNA <50 c/mL per FDA snapshot algorithm will be assessed. |
2. |
Percentage of participants with plasma HIV-1 RNA <50 c/mL - D2I [ Time Frame: At Months 5 and 11 ]
Participants with plasma HIV-1 RNA <50 c/mL per FDA snapshot algorithm will be assessed. |
3. |
Percentage of participants with plasma HIV-1 RNA <50 c/mL - BIK [ Time Frame: At Months 6 and 12 ]
Participants with plasma HIV-1 RNA <50 c/mL per FDA snapshot algorithm will be assessed. |
4. |
Percentage of participants with protocol-defined confirmed virologic failure (CVF) - OLI [ Time Frame: Up to Month 12 ]
CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL. |
5. |
Percentage of participants with protocol-defined CVF - D2I [ Time Frame: Up to Month 11 ]
CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL. |
6. |
Percentage of participants with protocol-defined CVF - BIK [ Time Frame: Up to Month 12 ]
CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/mL after prior suppression to <200 c/mL. |
7. |
Percentage of participants with HIV-RNA >= 50 c/mL - OLI [ Time Frame: At Month 6 ]
Participants with plasma HIV-1 RNA >=50 c/mL will be assessed per FDA snapshot algorithm. |
8. |
Percentage of participants with HIV-RNA >= 50 c/mL - D2I [ Time Frame: At Month 5 ]
Participants with plasma HIV-1 RNA >=50 c/mL will be assessed per FDA snapshot algorithm. |
9. |
Percentage of participants with HIV-RNA >= 50 c/mL - BIK [ Time Frame: At Month 6 ]
Participants with plasma HIV-1 RNA >=50 c/mL will be assessed per FDA snapshot algorithm. |
10. |
Absolute values of HIV viral load - OLI [ Time Frame: At Months 6 and 12 ]
Absolute values of HIV viral load will be assessed. |
11. |
Absolute values of HIV viral load - D2I [ Time Frame: At Months 5 and 11 ]
Absolute values of HIV viral load will be assessed. |
12. |
Absolute values of HIV viral load - BIK [ Time Frame: At Months 6 and 12 ]
Absolute values of HIV viral load will be assessed. |
13. |
Change from Baseline in HIV viral load (c/mL) - OLI [ Time Frame: Baseline (Day 1) and at Months 6 and 12 ]
Change from Baseline in HIV viral load will be assessed. |
14. |
Change from Baseline in HIV viral load (c/mL) - D2I [ Time Frame: Baseline (Day 1) and at Months 5 and 11 ]
Change from Baseline in HIV viral load will be assessed. |
15. |
Change from Baseline in HIV viral load (c/mL) - BIK [ Time Frame: Baseline (Day 1) and at Months 6 and 12 ]
Change from Baseline in HIV viral load will be assessed. |
16. |
Absolute values of cluster of differentiation 4 plus (CD4+) cell counts - OLI [ Time Frame: At Months 6 and 12 ]
Absolute values of CD4+ cell counts will be assessed. |
17. |
Absolute values of CD4+ cell counts - D2I [ Time Frame: At Months 5 and 11 ]
Absolute values of CD4+ cell counts will be assessed. |
18. |
Absolute values of CD4+ cell counts - BIK [ Time Frame: At Months 6 and 12 ]
Absolute values of CD4+ cell counts will be assessed. |
19. |
Change from Baseline in CD4+ cell counts (Cells per cubic millimeters [cells/mm^3]) - OLI [ Time Frame: Baseline (Day 1) and at Months 6 and 12 ]
Change from Baseline in CD4+ cell will be assessed. |
20. |
Change from Baseline in CD4+ cell counts (cells/mm^3) - D2I [ Time Frame: Baseline (Day 1) and at Months 5 and 11 ]
Change from Baseline in CD4+ cell will be assessed. |
21. |
Change from Baseline in CD4+ cell counts (cells/mm^3) - BIK [ Time Frame: Baseline (Day 1) and at Months 6 and 12 ]
Change from Baseline in CD4+ cell will be assessed. |
22. |
Number of participants with treatment-emergent phenotypic resistance - OLI [ Time Frame: Up to Month 12 ]
Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. |
23. |
Number of participants with treatment-emergent phenotypic resistance - D2I [ Time Frame: Up to Month 11 ]
Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. |
24. |
Number of participants with treatment-emergent phenotypic resistance - BIK [ Time Frame: Up to Month 12 ]
Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. |
25. |
Number of participants with treatment-emergent genotypic resistance - OLI [ Time Frame: Up to Month 12 ]
Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent genotypic resistance to CAB, RPV, BIC, FTC, and TAF. |
26. |
Number of participants with treatment-emergent genotypic resistance - D2I [ Time Frame: Up to Month 11 ]
Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent genotypic resistance to CAB, RPV, BIC, FTC, and TAF. |
27. |
Number of participants with treatment-emergent genotypic resistance - BIK [ Time Frame: Up to Month 12 ]
Plasma samples will be collected from participants experiencing protocol-defined CVF for assessing treatment-emergent genotypic resistance to CAB, RPV, BIC, FTC, and TAF. |
28. |
Number of participants with abnormal renal and bone biomarkers - OLI [ Time Frame: At Months 6 and 12 ]
Blood and urine samples will be collected over time to assess renal and bone biomarkers. |
29. |
Number of participants with abnormal renal and bone biomarkers - D2I [ Time Frame: At Months 5 and 11 ]
Blood and urine samples will be collected over time to assess renal and bone biomarkers. |
30. |
Number of participants with abnormal renal and bone biomarkers - BIK [ Time Frame: At Months 6 and 12 ]
Blood and urine samples will be collected over time to assess renal and bone biomarkers. |
31. |
Percentage of participants with Metabolic syndrome - OLI [ Time Frame: At Months 6 and 12 ]
Metabolic syndrome is a cluster of conditions that occurs together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions include increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. |
32. |
Percentage of participants with Metabolic syndrome - D2I [ Time Frame: At Months 5 and 11 ]
Metabolic syndrome is a cluster of conditions that occurs together increasing one's risk of heart disease, stroke and type 2 DM. These conditions include increased BP, elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and TG levels. |
33. |
Percentage of participants with Metabolic syndrome - BIK [ Time Frame: At Months 6 and 12 ]
Metabolic syndrome is a cluster of conditions that occurs together increasing one's risk of heart disease, stroke and type 2 DM. These conditions include increased BP, elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and TG levels. |
34. |
Number of participants with insulin resistance - OLI [ Time Frame: At Months 6 and 12 ]
Insulin resistance will be assessed using homeostasis model of assessment-insulin resistance (HOMA-IR) Score. |
35. |
Number of participants with insulin resistance - D2I [ Time Frame: At Months 5 and 11 ]
Insulin resistance will be assessed using HOMA-IR Score. |
36. |
Number of participants with insulin resistance -BIK [ Time Frame: At Months 6 and 12 ]
Insulin resistance will be assessed using HOMA-IR Score. |
37. |
Percentage of participants with their treatment Preference as Assessed Using Preference Questionnaire - OLI [ Time Frame: At Month 12 ]
The "Preference" questionnaire will include 3 questions and assess whether participants prefer the CAB LA + RPV LA injectable treatment or the daily oral ARV regimen, also evaluating the attributes supporting this preference. |
38. |
Percentage of participants with their Treatment Preference as Assessed Using Preference Questionnaire - D2I [ Time Frame: At Month 11 ]
The "Preference" questionnaire will include 3 questions and assess whether participants prefer the CAB LA + RPV LA injectable treatment or the daily oral ARV regimen, also evaluating the attributes supporting this preference. |
39. |
Percentage of Participants with their treatment Preference as Assessed Using Preference Questionnaire - BIK [ Time Frame: At Month 12 ]
The "Preference" questionnaire will include 3 questions and assess whether participants prefer the CAB LA + RPV LA injectable treatment or the daily oral ARV regimen, also evaluating the attributes supporting this preference. |
40. |
Change From Baseline in Total Treatment Satisfaction Score using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) (scores on a scale) - OLI [ Time Frame: Baseline (Day 1) and at Months 6 and 12 ]
The HIVTSQs treatment satisfaction questionnaire comprises of 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores represent greater treatment satisfaction as compared to the past few weeks. |
41. |
Change From Baseline in Total Treatment Satisfaction Score using HIVTSQs (scores on a scale) - D2I [ Time Frame: Baseline (Day 1) and at Months 5 and 11 ]
The HIVTSQs treatment satisfaction questionnaire comprises of 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores represent greater treatment satisfaction as compared to the past few weeks. |
42. |
Change From Baseline in Total Treatment Satisfaction Score using HIVTSQs (scores on a scale)- BIK [ Time Frame: Baseline (Day 1) and at Months 6 and 12 ]
The HIVTSQs treatment satisfaction questionnaire comprises of 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores represent greater treatment satisfaction as compared to the past few weeks. |
43. |
Change From Baseline in individual item scores using HIVTSQs (scores on a scale) - OLI [ Time Frame: Baseline (Day 1) and at Months 6 and 12 ]
HIVTSQs is a 12 item questionnaire. The individual item scores on HIVTSQs scale are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. |
44. |
Change From Baseline in individual item scores using HIVTSQs (scores on a scale) - D2I [ Time Frame: Baseline (Day 1) and at Months 5 and 11 ]
HIVTSQs is a 12 item questionnaire. The individual item scores on HIVTSQs scale are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. |
45. |
Change From Baseline in individual item scores using HIVTSQs (scores on a scale) - BIK [ Time Frame: Baseline (Day 1) and at Months 6 and 12 ]
HIVTSQs is a 12 item questionnaire. The individual item scores on HIVTSQs scale are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. |
46. |
Number of participants with change in treatment satisfaction over time using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc)- OLI [ Time Frame: At Month 12 ]
The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 will represent no change. |
47. |
Number of participants with change in treatment satisfaction over time using HIVTSQc - D2I [ Time Frame: At Month 11 ]
The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 will represent no change. |
48. |
Number of participants with change in treatment satisfaction over time using HIVTSQc - BIK [ Time Frame: At Month 12 ]
The HIVTSQc is a 1-12 items questionnaire. Each item is scored -3 to 3. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 will represent no change. |
49. |
Number of participants with change in Dimension Scores Using Perception of Injection (PIN) Questionnaire - OLI [ Time Frame: At Months 2, 6, and 12 ]
The PIN questionnaire explores the bother of pain at the injection site and injection site reaction (ISRs), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. The items in the scale are rated on a 5-point scale and questions are phrased in such a way as to ensure that 1 is always equated with the most favorable perception of vaccination, and 5 is the most unfavorable. |
50. |
Number of participants with change in Dimension Scores Using PIN Questionnaire - D2I [ Time Frame: At Months 1, 5, and 11 ]
The PIN questionnaire explores the bother of pain at the injection site and injection site reaction (ISRs), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections. This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. The items in the scale are rated on a 5-point scale and questions are phrased in such a way as to ensure that 1 is always equated with the most favorable perception of vaccination, and 5 is the most unfavorable. |