| Primary | Percentage of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48 | Percentage of participants with virologic failure endpoint (HIV-1 RNA>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the noninferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC regimen over 48 weeks in HIV-1 infected ARTexperienced participants. The HIV-1 RNA >=50 copies/mL per snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks) or at time of discontinuation (if discontinuation occurred prior to Week 48 for reasons other than Adverse Event). | Intent-to treat exposed (ITT-E) participants included all randomized participants who received at least one dose of Investigational Product (IP) during the Maintenance Phase. Participants were analyzed according to the randomized treatment regardless of what treatment actually received. | Posted | | Number | | Percentage of Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Adjusted difference in proportion | -0.4 | | | 2-Sided | 95 | -2.8 | 2.1 | | | | | Non-Inferiority | Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA >=50 c/mL) can be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in failure rates between the two treatment arms (CAB - ABC/DTG/3TC) is less than 6%. | Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (<100,000 >=100,000 c/mL) |
|
| Secondary | Percentage of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48 | Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC. The HIV-1 RNA <50 copies/mL per snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks). Participants with no data in the analysis window were classificated as non-responders. | | Posted | | Number | | Percentage of Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 |
|
| Secondary | Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48 | Percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC | | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA |
|
| Secondary | Number of Participants With Confirmed Virologic Failure (CVF) During the Maintenance Phase | The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL. | | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA |
|
| Secondary | Absolute Values for Plasma HIV-1 RNA at Week 48 | Plasma for quantitative HIV-1 RNA were collected at indicated time points. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. | ITT-E Population. Only those participants with data available at the specified data points were analyzed | Posted | | Mean | Standard Deviation | log10 copies/mL | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA |
|
| Secondary | Change From Baseline Values for Plasma HIV-1 RNA at Week 48 | Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 minus HIV-1 RNA(log 10) at Baseline. | ITT-E Population. Only those participants with data available at the specified data points were analyzed | Posted | | Mean | Standard Deviation | log10 copies/mL | | Baseline (Day 1) and at Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA |
|
| Secondary | Absolute Values for CD4+ Lymphocyte Count at Week 48 | Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC | ITT-E Population. Only those participants with data available at the specified data points were analyzed | Posted | | Mean | Standard Deviation | Cells per cubic millimeter | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA |
|
| Secondary | Change From Baseline Values for CD4+ Lymphocyte Count at Week 48 | Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value at Week 48 minus Maintenance Baseline value. | ITT-E Population. Only those participants with data available at the specified data points were analyzed | Posted | | Mean | Standard Deviation | Cells per cubic millimeter | | Baseline (Day 1) and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | |
|
| Secondary | Number of Participants With Disease Progression | Data for participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented. CDC stage is derived according to lowest post baseline CD4+ T-lympohocyte count and/or occurrence of AIDS-defining conditons (per 2014 CDC criteria). | | Posted | | Count of Participants | | Participants | | Day 1 up to an average of 59 weeks | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA |
|
| Secondary | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is 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 judgment. Safety Population: all randomized participants who received at least 1 dose of IP during maintenance phase and assessed according to actual treatment received. All Maintenance Phase AEs was presented including AEs with start date occurring on/after date of 1st dose of randomized treatment, up to and including start date of LTFU antiretroviral therapy for participants who discontinued from Q4W arm. Non-SAE counts in >=5% of participants within any arm is reported | | Posted | | Count of Participants | | Participants | | Day 1 up to an average of 59 Weeks | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Number of Participants With Severity of Adverse Events | Severity of adverse events (AEs) were defined as per The Division of acquired immuno deficiency syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE. All Maintenance Phase adverse events have been presented, which includes AEs with start date occuring on or after the date of first dose of randomized study treatment, up to and including the start date of LTFU antiretroviral therapy for participants who discontinued from the Q4W arm. | | Posted | | Count of Participants | | Participants | | Up to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | 10^9 cells per Liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 |
|
| Secondary | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Femtoliters | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | |
|
| Secondary | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | 10^12 cells per Liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA |
|
| Secondary | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA |
|
| Secondary | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | |
|
| Secondary | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated timepoints. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | International units per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 |
|
| Secondary | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated timepoints. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA |
|
| Secondary | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated timepoints. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC |
|
| Secondary | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated timepoints. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 |
|
| Secondary | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated timepoints. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Units per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA |
|
| Secondary | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) will be estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | mL/min/1.73/m^2 | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 |
|
| Secondary | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day 1) and at Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | |
|
| Secondary | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to DAIDS scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and at Weeks 4, 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | 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). | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Count of Participants | | Participants | | Baseline (Day 1) and at Weeks 4, 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 |
|
| Secondary | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | 10^9 cells per Liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Femtoliters | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | |
|
| Secondary | Change From Baseline for Hematology Parameters: Erythrocytes | Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | 10^12 cells per Liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | |
|
| Secondary | Change From Baseline for Hematology Parameters: Hematocrit | Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Proportion of red blood cells in blood | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | |
|
| Secondary | Change From Baseline for Hematology Parameters: Hemoglobin | Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | International units per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | |
|
| Secondary | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Units per liter | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | |
|
| Secondary | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | mL/min/1.73/m^2 | | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | Blood samples were collected at Baseline and at Week 48 to assess glucose and fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Only fasting data is presented for glucose and lipids. Baseline value is defined as the last available fasting recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at Week 48 visit (if collected while fasting) minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day 1) and at Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Grams per mole | | Baseline (Day 1) and at Weeks 4, 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline Values in Urine Creatinine Over Time Including Week 48 | Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day 1) and at Weeks 4, 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 |
|
| Secondary | Change From Baseline Values in Urine Phosphate Over Time Including Week 48 | Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline (Day 1) and at Weeks 4, 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 |
|
| Secondary | Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48 | Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Nanomoles per liter | | Baseline (Day 1) and at Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC |
|
| Secondary | Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 | Urine biomarker 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. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Ratio of urine density to water density | | Baseline (Day 1) and at Weeks 4, 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline Values in Urine pH Over Time Including Week 48 | 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). Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | pH | | Baseline (Day 1) and at Weeks 4, 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48 | An AE 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. All Maintenance Phase adverse events (start date occurring on or after the date of first dose of randomized study treatment) leading to withdrawal have been presented. | | Posted | | Count of Participants | | Participants | | Up to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC | |
|
| Secondary | Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 | Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the last available recorded fasting value up to and including the date of first Maintenance Phase dose of IP. Percentage change from baseline is calculated as: value at Week 48 (if collected while fasting) minus Baseline value divided by Baseline value multiplied by 100. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline (Day 1) and at Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Number of Participants With Phenotypic Resistance Through Week 48 | Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Phenotypic Resistance data for following drugs :CAB,dolutegravir(DTG),elvitegravir (EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,lamivudine(3TC),abacavir(ABC),emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI),atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) in participants meeting CVF criteria is presented.Phenotypic resistance, partially sensitive, and Sensitive were defined based on fold change(FC) value from Monogram as:resistance (FC>clinical higher cutoff/biologic cutoff),partially sensitive (FC=clinical higher cutoff and > clinical lower cutoff),sensitive(FC<=clinical lower cutoff/biologic cutoff). The CVF population comprised of all participants in ITT-E population who met CVF criteria | CVF Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Number of Participants With Genotypic Resistance Through Week 48 | Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented. | CVF Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | | OG001 | ABC/ DTG/ 3TC |
|
| Secondary | Area Under the Curve (AUC) for CAB LA | AUC values are Bayesian pharmacokinetic (PK) parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for CAB LA. The PK Population includes all participants who received CAB and / or RPV and undergo PK sampling during the study, and provide CAB and /or RPV plasma concentration data. | | Posted | | Geometric Mean | 95% Confidence Interval | Hours*micrograms per milliliter | | Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA | Participants in this arm received CAB 30 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral CAB and first dose CAB LA 600 mg injections. Participants received IM injections of CAB LA 400 mg at Week 8 and every four weeks through Week 100. |
| |
| Secondary | AUC for RPV LA | AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for RPV LA | | Posted | | Geometric Mean | 95% Confidence Interval | Hours*nanograms per milliliter | | Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA | Participants in this arm received CAB 30 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral CAB and first dose CAB LA 600 mg injections. Participants received IM injections of CAB LA 400 mg at Week 8 and every four weeks through Week 100. |
| |
| Secondary | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Blood samples were collected at indicated time points for PK analysis of CAB LA. | PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Geometric Mean | 95% Confidence Interval | Microgram per milliliter | | Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA | Participants in this arm received CAB 30 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral CAB and first dose CAB LA 600 mg injections. Participants received IM injections of CAB LA 400 mg at Week 8 and every four weeks through Week 100. |
| |
| Secondary | Ctrough for RPV LA Evaluable | Blood samples were collected at indicated time points for PK analysis of RPV LA. | PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Geometric Mean | 95% Confidence Interval | Nanograms per milliliter | | Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | | | | ID | Title | Description |
|---|
| OG000 | RPV LA | Participants in this arm received RPV 25 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral RPV and first dose CAB LA 900 mg injections. Participants received IM injections of RPV LA 600 mg at Week 8 and every four weeks through Week 100. |
| |
| Secondary | Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41 | Blood samples will be collected at indicated time points for PK analysis of CAB LA. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Geometric Mean | 95% Confidence Interval | Micrograms per milliliter | | Week 41- 1 Week post dose | | | | ID | Title | Description |
|---|
| OG000 | CAB LA | Participants in this arm received CAB 30 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral CAB and first dose CAB LA 600 mg injections. Participants received IM injections of CAB LA 400 mg at Week 8 and every four weeks through Week 100. |
| |
| Secondary | Cmax in Plasma for RPV LA Evaluable at Week 41 | Blood samples will be collected at indicated time points for PK analysis of RPV LA. | PK Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Geometric Mean | 95% Confidence Interval | Nanograms per milliliter | | Week 41- 1 Week post dose | | | | ID | Title | Description |
|---|
| OG000 | RPV LA | Participants in this arm received RPV 25 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral RPV and first dose CAB LA 900 mg injections. Participants received IM injections of RPV LA 600 mg at Week 8 and every four weeks through Week 100. |
| |
| Other Pre-specified | Number of Participants With Different Demographic Parameters for Inter-subject Variability | Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter subject variability for pharmacokinetic parameters. | PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported. | Posted | | | | | | Up to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA | Participants in this arm received CAB 30 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral CAB and first dose CAB LA 600 mg injections. Participants received IM injections of CAB LA 400 mg at Week 8 and every four weeks through Week 100. | | OG001 | RPV LA | Participants in this arm received RPV 25 mg once daily for 4 Weeks during Maintenance Phase (Day 1 to Week 100). At Week 4b visit, participants received last dose of oral RPV and first dose CAB LA 900 mg injections. Participants received IM injections of RPV LA 600 mg at Week 8 and every four weeks through Week 100. |
| |
| Secondary | Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) | PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis | ITT-E Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Weeks 5 and at Weeks 41 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment, following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis. | ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Number | | Percentage of participants | | Weeks 5, 41 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire | The HATQoL questionnaire was used to assess health related QoL (HRQoL). It comprises of three dimensions: life satisfaction (LISAT), medication worries (MEDWO) and disclosure worries (DISWO). For LISAT domain, each question is scored as 1-5, where 5 corresponds to satisfaction 'all of time' and 1 as 'none of time'. Total score for the LISAT domain (sum of item scores for questions 1a to 1d) is transformed to a 0-100 scale using formula:[100 divided by (20 minus 4)]*(raw total score for LISAT minus 4). Higher the LISAT score, greater satisfaction to life. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. | ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | 95% Confidence Interval | Scores on a scale | | Baseline (Day 1) and at Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline in HIV Medication, MEDWO Using HATQoL | The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the MEDWO domain, each question is scored as 1-5, where 5 is associated with medication worry 'none of the time' and 1 as 'all of the time'. The total score for the MEDWO domain (sum of item scores for questions 2a to 3e) is transformed to a 0-100 scale using formula: [100 divided by (25 minus 5)]* (raw total score for MEDWO minus 5). Higher MEDWO scores correspond to lower medication worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. | ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | 95% Confidence Interval | Scores on a scale | | Baseline and at Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline in DISWO Using HATQoL | The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the DISWO domain, each question is scored as 1-5, where 5 is associated with disclosure worry 'none of the time' and 1 as 'all of the time'. The total score for the DISWO domain (sum of item scores for questions 3a to 3e) is transformed to a 0-100 scale using formula: [100 divided by (25 minus 5)]* (raw total score for DISWO minus 5). Higher DISWO total scores correspond to lower disclosure worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. | ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | 95% Confidence Interval | Scores on a scale | | Baseline and at Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) | The SF-12 questionnaire consists of 7 questions which measures degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. HRQoL using SF-12 for physical component summary (PCS) and mental component summary (MCS) were assessed for two treatment groups.Missing component scores was imputed using LOCF.PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com).The higher the score, the better will be the health status.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. | ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | 95% Confidence Interval | Scores on a scale | | Baseline and at Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44 | HIVTSQs (status version) 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. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Adjusted mean and 95% CI of adjusted mean values has been presented. | ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | 95% Confidence Interval | Scores on a scale | | Baseline and at Weeks 4b, 24 and 44 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change in Treatment Satisfaction Over Time Using HIVTSQc at Week 48 | 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 representedeterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. | ITT-E Population. Only those participants with data available at the specified data points were analyzed | Posted | | Mean | Standard Error | Scores on a scale | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | HIVTSQs (status version) is a 12 item questionnaire. The individual item scores are ratedas 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. LOCF was used as primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. | ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and at Weeks 4b, 24 and 44 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire | ACCEPT questionnaire is generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication. It consists 25 items, capturing six dimensions. 3 questions focusing on general acceptance of study medication were analyzed. Items scores are rated as 1-5 :1-totally disagree,2-somewhat disagree,3-somewhat agree,4-totally agree and 5-I don't know. The acceptance domain score (ranging from 0 to 100) is calculated using the following formula:100*(mean of recoded items in dimension minus 1) divided by 2.LOCF was primary method of analysis. Measure type is mean for adjusted mean and dispersion measure: 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. | ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | 95% Confidence Interval | Scores on a scale | | Baseline and at Weeks 8, 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
|
| Secondary | Change From 4b in Tolerability of Injection at Weeks 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm | The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF. | ITT-E Population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Weeks 4b, 5, 40 and 41 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA + RPV LA (Q4W) | Participants who received ABC/DTG/3TC for 20 Weeks (Week [-20] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. |
| |