| Primary | Change From Baseline in the Acceptability of Intervention Measure (AIM) Total Score in Staff Study Participants at Month 4 | AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | All Staff study participants Population comprised of HIV care providers (HCPs), nurses/staff performing CAB+RPV LA injections and administrators/clinic managers at each investigational site. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Month 4 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Change From Baseline in AIM Total Score in Staff Study Participants at Month 12 | AIM is a four item survey that assessed the acceptability of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the AIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | All staff study participants population. Only those staff study participants who completed the survey were included in the analysis. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| |
| Primary | Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 4 | AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety population consisted of all participants who were enrolled and received atleast one dose of CAB LA + RPV LA. Only those participants who completed the survey were included in the analysis | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Month 4 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Primary | Change From Baseline in AIM Total Score in Participants With HIV Infection at Month 12 | AIM is a four item survey that assessed the acceptability of an implementation process. The participants were asked about their impressions of the CAB LA + RPV LA injection treatment for treating HIV on a five point rating scale (1=completely disagree to 5=completely agree). The AIM total score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety population. Only those participants who completed the survey were included in the analysis | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Primary | Change From Baseline in Intervention Appropriateness Measure (IAM) Score in Staff Study Participants at Month 4 | IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | All Staff study participants population | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Month 4 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| |
| Primary | Change From Baseline in IAM Score in Staff Study Participants at Month 12 | IAM is a four item survey that assessed the appropriateness of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | All Staff study participant population. Only those staff study participants who completed the survey were included in the analysis. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| |
| Primary | Change From Baseline in IAM Score in Participants With HIV Infection at Month 4 | IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety population. Only those participants who completed the survey were included in the analysis. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Month 4 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Primary | Change From Baseline in IAM Score in Participants With HIV Infection at Month 12 | IAM is a four item survey that assessed the appropriateness of an implementation process. The participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the IAM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The IAM total score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Primary | Change From Baseline in Feasibility of Intervention Measure (FIM) Total Score in Staff Study Participants at Month 4 | FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | All staff study participants Population | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Month 4 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| |
| Primary | Change From Baseline for FIM Total Score in Staff Study Participants at Month 12 | FIM is a four item survey that assessed the feasibility of an implementation process. The staff study participants were asked to indicate how much they agreed or disagreed with each of the 4 items in the FIM based on their current experiences with implementing the CAB + RPV injection treatment on a five point rating scale (1=completely disagree to 5=completely agree). The FIM total score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | All staff study participants population. Only those staff study participants who completed the survey were included in the analysis. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| |
| Secondary | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 4 | The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 4 is presented. | All staff study participants population. | Posted | | Count of Participants | | Participants | | At Month 4 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| |
| Secondary | Number of Staff Study Participants Reported Helpfulness of Toolkit Resources at Month 12 | The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Not Applicable (NA) in the categories mean response was not offered. The toolkit resources consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, WB treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. The number of participants with the rating on helpfulness for each toolkit resources at Month 12 is presented. | All staff study participants population. Only those staff study participants who completed the survey were included in the analysis. | Posted | | Count of Participants | | Participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| |
| Secondary | Number of Participants With Change in Barriers to Implementation (BIM) Measure Items Between Baseline and Month 4 Using SSI in Staff Study Participants | BIM is a 23-item survey which assessed barriers (that is, difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline. | All staff study participants population. | Posted | | Count of Participants | | Participants | | Baseline and Month 4 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| |
| Secondary | Percentage of Participants With Change in BIM Measure Items Between Baseline and Month 12 Using SSI in Staff Study Participants | BIM is a 23-item survey which assessed barriers (i.e., difficulties and challenges) to successful implementation of the CAB LA + RPV LA injection treatment in the study clinic/practices. For each item, providers were asked to rate how much they agreed or disagreed that the issue is a barrier based on their experiences with implementing the CAB + RPV treatment on a five point rating scale (1=completely disagree to 5=completely agree). It is presented as fewer perceived barriers (FPB)=all negative change in scores from Baseline, some perceived barriers (SPB)=change in score of 0 from Baseline, and greater/more perceived barriers (MPB)=all positive change in scores from Baseline. | All staff study participants population. Only those participants with data available at the specified data points were analyzed. | Posted | | Number | | Percentage of participants | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| |
| Secondary | Number of Participants With HIV Infection Reported Helpfulness of Toolkit Resources at Month 12 | The helpfulness of the toolkit resources was identified using a 19-item survey and the helpfulness of the resources were rated on a five point scale where 1=Extremely helpful (EH), 2=Very helpful (VH), 3=Somewhat helpful (SH), 4=A little helpful (ALH) and 5=Not at all helpful (NAAH). Categories for did not receive (DNR) and recevied but did not use (RBDNU) were presented as well. Not Applicable (NA) in the data means participants were not offered the response option. The toolkit resources consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. The number of participants with the rating on helpfulness for each toolkit resources is presented. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Count of Participants | | Participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Secondary | Number of Participants With HIV Reporting Barriers to CAB LA + RPV LA Injection Treatment at Month 12 | Participants were asked to report any factors that were interfering with their ability to get the monthly CAB LA + RPV LA injection treatment. Number of participants along with the reasons for interference in ability to get CAB LA + RPV LA is presented. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Count of Participants | | Participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Barriers Assessed Among Clinics Using Short-term Facilitation | The barriers were analyzed using semi-structured interviews from the validated consolidated framework for implementation research (CFIR) across 7 calls. An implementation science approach was used to understand the barriers for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants. | | Posted | | Number | | Barriers | | Up to 6 months | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Facilitators Assessed Among Clinics Using Short-term Facilitation | The facilitators were analyzed using semi-structured interviews from the validated CFIR across 7 calls. An implementation science approach was used to understand the facilitators for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants. | | Posted | | Number | | Facilitators | | Up to 6 months | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Best Practices Assessed Among Clinics Using Short-term Facilitation | The best practices were analyzed using short-term facilitation calls. An implementation science approach was used to understand the best practices for participants with HIV for delivering CAB + RPV LA within an interventional clinical trial where the CAB + RPV LA regimen was delivered to HIV infected, virologically-suppressed participants. | | Posted | | Number | | Best practices | | Up to 6 months | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Staff Study Participants Using Support Materials/Toolkit at Month 4 | Number of staff study participants using support materials/toolkit at Month 4 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. | All Staff study participants population | Posted | | Count of Participants | | Participants | | At Month 4 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| |
| Secondary | Number of Staff Study Participants Using Support Materials/Toolkit at Month 12 | Number of staff study participants using support materials/toolkit at Month 12 was assessed by variables: Not used, Used similar resource, used the support materials/toolkit. The support materials/toolkit consisted of website for clinical staff, video on giving CAB + RPV LA, how to use new packaging card, study factsheet for healthcare providers, consultation aid, reminder e-application, reminder SMS/text, face-to-face training by healthcare staff, facilitation group calls, web-based (WB) treatment planner, WB health clinic capacity planning tool, injection flashcards, website for participants, what to expect factsheet for participants, handbook, FAQ chatbot, trial guide app, video-what to expect and hot and cold packs. | All staff study participants population. Only those participants with data available at the specified data points were analyzed. | Posted | | Count of Participants | | Participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
| |
| Secondary | Percentage of Participants With HIV Reporting Helpfulness of the Use of Support Materials/Toolkit at Month 4 | Participants with HIV infection were asked about their utilization of each element of the support materials/toolkit and were asked to categorize it as Extremely helpful (EH) Very helpful (VH), Somewhat helpful (SH), A little helpful (ALH), Not at all helpful (NAAH), did not receive (DNR), Received but did not use (RBDNU) and missing. Not Applicable (NA) in the data means participants were not offered the response option. The support materials/toolkit consisted of information and resources, hot and cold pack, written materials, website for participants, video, verbal information, reminder calls, reminder text messages, reminder app, peer group information session and appointments outside work time. Percentage of participants with the rating on helpfulness for each toolkit resources is presented. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Number | | Percentage of participants | | At Month 4 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Secondary | Number of Participants Receiving Injections Within Target Window at Month 4 | Number of participants receiving injections within target window at Month 4 is presented. The target window is +/- 7 days from the target injection visit date. | Safety population. Only those participants with data available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | At Month 4 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants Receiving Injections Within Target Window at Month 12 | Number of participants receiving injections within target window at Month 12 is presented. The target window is +/- 7 days from the target injection visit date. | Safety population. Only those participants with data available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Implementation Sustainability Assessed in Staff Study Participants Using Program Sustainability Assessment Tool (PSAT) Scores | Implementation sustainability in staff study participants was assessed using PSAT tool that evaluated capability of clinics to maintain processes developed to administer CAB+RPV injection in routine clinical settings after study conclusion.It consisted of 6 domains(1.Environmental support,2.Organizational capacity,3.Program evaluation,4.Program adaptation,5.Communications and 6.Strategic planning).Each domain consisted of 5 items,each assessed using 7-point numerical rating scale:1=to not extent at all,7=to a very great extent and an eighth not applicable/not able to answer response(NA).Score ranges for total domain scores are 5 to 35 for each of 6 domains(5 items in each domain on 1 to 7 scale).Numeric response to each item within specific domain is summed to produce a total domain score then mean domain score is calculated(excluding any NA responses).Higher scores indicate better outcome(higher endorsement/more positive impressions by staff-study with sustainability survey concepts) | All staff study participants population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Staff Study Participants | Staff study participants included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input through the use of surveys, semistructured interviews (SSI) and via monthly facilitation calls |
|
| Secondary | HIV Treatment Satisfaction Questionnaire Status Version (HIV-TSQs) Scores at Month 1 | Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were 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. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | At Month 1 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Secondary | HIV-TSQs Scores at Month 4 | Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were 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. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | At Month 4 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | HIV-TSQs Scores at Month 12 | Participant satisfaction was measured using the validated HIV Treatment Satisfaction Questionnaire (HIV-TSQ), status version (HIV-TSQs), which measured satisfaction with the treatment used in the previous few weeks. HIVTSQs total treatment satisfaction score was computed with 1-11 items. Each item was scored from 0 (least satisfied) to 6 (most satisfied). Items 1-11 were 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. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Reported Acceptability of the Amount of Time Spent in the Clinic for Each Injection Visit | The results for participant reported acceptability of the amount of time spent in the clinic for each injection visit is presented. Participants were asked to rate the acceptability of the amount of time spent in the clinic for each injection visit as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable and not at all acceptable. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Count of Participants | | Participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With the Reported Time Spent in Clinic/Practice for Each Injection Visit | Number of participants with the reported time spent in clinic/practice for each injection visit is presented. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Count of Participants | | Participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Extent of Knowledge About the CAB + RPV LA Treatment | Participants were asked to rate how knowledgeable they feel about the CAB LA + RPV LA treatment as extremely knowledgeable, very knowledgeable, somewhat knowledgeable, a little knowledgeable and not at all knowledgeable. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Count of Participants | | Participants | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Length of Participant Visit | Length of visit was calculated by subtracting the arrival time (Lead time [actual start time of appointment - arrival time] + process time [actual end time of appointment - actual start time of appointment]) from actual end time of appointment. | 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 | Minutes | | At Months 1, 5 and 11 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies/Milliliter (c/mL) by Modified Food and Drug Administration (FDA) Snapshot Algorithm | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <50 c/mL (virologic success) was evaluated using the modified Food and Drug Administration (FDA) snapshot algorithm with Coronavirus Disease 2019 (COVID-19) related missing value imputed using the last observation carried forward (LOCF) approach. | | Posted | | Number | | Percentage of participants | | Month 1, Month 2, Month 4, Month 6, Month 8, Month 10 and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL - Observed Case | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage value presented has been rounded off. | Safety 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 | | Months 1, Month 2, Month 4, Month 6, Month 8, Month 10, Month 12, Month 13, Month 15, Month 16, Month 18, Month 19, Month 21, Month 22, Month 24, Month 25, Month 27, Month 28 and Month 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Percentage of Participants With Confirmed Virologic Failure (CVF) | Plasma samples were collected for quantitative analysis of HIV-1 RNA. The CVF is defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels greater than or equal to (>=)200 copies/mL after prior suppression to <200 copies/mL. | | Posted | | Number | | Percentage of participants | | Up to 30 months | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Treatment Emergent Genotypic Resistance to CAB and RPV | Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels >=200 copies/mL after prior suppression to <200 copies/mL) with emergent genotypic resistance is summarized. | Safety population. Only participants with CVF were included in the analysis | Posted | | | | | | Up to 30 months | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Treatment Emergent Phenotypic Resistance to CAB and RPV | Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1 RNA levels >=200 copies/mL after prior suppression to <200 copies/mL) with emergent phenotypic resistance is summarized. | Safety population. Only participants with CVF were included in the analysis | Posted | | | | | | Up to 30 months | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Common (>=5 Percent [%]) Non-serious Adverse Events (Non-SAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Number of participants with any SAE and common (>=5%) non-SAEs are presented. Adverse events which were not serious have been considered as non-serious adverse events. | | Posted | | Count of Participants | | Participants | | Up to 30 months | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Secondary | Percentage of Participants Who Discontinue Treatment or Withdraw From Study Due to AEs Over Time | 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. Percentage of participants with adverse events leading to study treatment or study withdrawal has been presented. The percentage value presented has been rounded off. | | Posted | | Number | | Percentage of participants | | Up to 30 months | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood samples were collected for the analysis of following hematology parameters: leukocytes, neutrophils and platelets. The parameters were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms. | | Posted | | Count of Participants | | Participants | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Blood samples were collected for the analysis of following hematology parameters: hemoglobin, leukocytes, neutrophils and platelets. The parameters were graded according to the DAIDS toxicity scale from Grade 1 to 4, where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms. | | Posted | | Count of Participants | | Participants | | Up to 30 months | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline | Blood samples were collected up to the Month 12 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), creatine kinase (CK), creatinine, direct bilirubin, glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms. | | Posted | | Count of Participants | | Participants | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Clinical Chemistry Results by Maximum Grade Increase Post-Baseline Relative to Baseline Through End of Study | Blood samples were collected for the analysis of clinical chemistry parameters: ALT, ALP, AST, bilirubin, CO2, CK, creatinine, direct bilirubin, Glomerular filtration rate (GFR) from Creatinine (Creat) Adjusted (Adj) using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), GFR From Creat Adj for body surface area (BSA), glucose, lipase, phosphate, potassium and sodium. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). Higher the grade, more severe the symptoms. | | Posted | | Count of Participants | | Participants | | Up to 30 months | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Secondary | Number of Participants With Urinalysis Result of Potential Clinical Importance | Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented. | | Posted | | Count of Participants | | Participants | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Urinalysis Result of Potential Clinical Importance Through End of Study | Urine samples were collected to analyze the urine parameters: Protein, occult blood or glucose. Potential clinical importance is defined as an increase in protein (dipstick) or occult blood (dipstick) post-Baseline relative to Baseline. Number of participants with results of potential clinical importance in any of the urine parameters is presented. | | Posted | | Count of Participants | | Participants | | Up to 30 months | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Injection Site Reactions (ISRs) Over Time | Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented. | | Posted | | Count of Participants | | Participants | | Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Number of Participants With Injection Site Reactions (ISRs) Over Time From Month 13 to Month 30 | Local tolerability was measured by injection site reaction (ISR), for example; bruise at the site of injection and/or itching, pain, blistering or skin damage. ISRs were assigned to the most recent planned injection visit prior to/on the onset date of the ISR. Number of participants with ISRs by each assigned injection visit is presented. | | Posted | | Count of Participants | | Participants | | Months 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 and 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose 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 and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Secondary | Change From Baseline in Hematology Parameter: Red Blood Cell (RBC) Count | Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Percentage of red blood cells in blood | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume (MCV) | Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Femtoliter | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Hematology Parameters: Platelet Count, White Blood Cell (WBC) Count, Basophil Count, Eosinophil Count, Lymphocyte Count , Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Blood samples were collected to analyze the hematology parameters: Platelet count, WBC count, Basophil count, Eosinophil count, Lymphocyte count, Monocyte count and Neutrophil count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose 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 and Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Secondary | Change From Baseline in Hematology Parameter-Red Blood Cell (RBC) Count From Month 15 to Month 30 | Blood samples were collected to analyze the hematology parameter: RBC count. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose 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 and Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose 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 and Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Hematology Parameter-Hematocrit From Month 15 to Month 30 | Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose 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 | Percentage of red blood cells in blood | | Baseline and Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Volume (MCV) From Month 15 to Month 30 | Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose 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 | Femtoliter | | Baseline and Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of the Hematology Parameters: Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count | Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count. | 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 | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Hematology Parameter: RBC Count | Blood samples were collected to analyze the hematology parameter: RBC count. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | 10^12 cells per liter | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Hematology Parameter: Hemoglobin | Blood samples were collected to analyze the hematology parameter: Hemoglobin | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Grams per liter | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1) | Safety population. Only those participants with data available at the specified data points were analyzed | Posted | | Mean | Standard Deviation | Percentage of red blood cells in blood | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Hematology Parameter: Erythrocytes MCV | Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Femtoliter | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of the Hematology Parameters of Platelet Count, WBC Count, Basophil Count, Eosinophil Count, Lymphocyte Count, Monocyte Count and Neutrophil Count From Month 15 to Month 30 | Blood samples were collected for the analysis of hematology parameters including platelet count, WBC count, basophil count, eosinophil count, lymphocyte count, monocyte count and neutrophil count. | 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 | | Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Hematology Parameter-RBC Count From Month 15 to Month 30 | Blood samples were collected to analyze the hematology parameter: RBC count. | 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 | | Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Hematology Parameter-Hemoglobin From Month 15 to Month 30 | Blood samples were collected to analyze the hematology parameter: Hemoglobin. | 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 | | Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Hematology Parameter-Hematocrit From Month 15 to Month 30 | Blood samples were collected to analyze the hematology parameter: Hematocrit (fraction of 1). | 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 | Percentage of red blood cells in blood | | Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Hematology Parameter-Erythrocytes MCV From Month 15 to Month 30 | Blood samples were collected to analyze the hematology parameter: Erythrocytes MCV. | 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 | Femtoliter | | Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin | Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | International units per liter | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value. | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Milliliters/seconds/1.73 meter square | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Lipase | Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. 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 indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Units per liter | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Clinical Laboratory Parameter: Albumin | Blood samples were collected for the analysis of clinical chemistry parameter: Albumin. 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 indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose 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 | Millimoles per liter | | Baseline and Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose 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 | Micromoles per liter | | Baseline and Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose 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 | International units per liter | | Baseline and Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Blood samples were collected from participants at indicated time points to analyze the clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline is defined as the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose 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 | Milliliters/seconds/1.73 meter square | | Baseline and Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
|
| Secondary | Change From Baseline in Clinical Laboratory Parameter- Lipase From Month 15 to Month 30 | Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. 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 | Units per liter | | Baseline and Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Change From Baseline in Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Blood samples were collected for the analysis of clinical chemistry parameter-Albumin. 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 | Grams per liter | | Baseline and Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Chemistry Laboratory Parameters: Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate | Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. | Safety population. Only those participants with data available at the specified data points were analyzed. | Posted | | Mean | Standard Deviation | Millimoles per liter | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin | Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Micromoles per liter | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase | Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | International units per liter | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Laboratory Parameter: Glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) | Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Milliliters/seconds/1.73 meter square | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Laboratory Parameter: Lipase | Blood samples were collected for the analysis of clinical chemistry parameter: Lipase. | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Units per liter | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Laboratory Parameter: Albumin | Blood samples were collected for the analysis of clinical chemistry parameter: Albumin. | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Posted | | Mean | Standard Deviation | Grams per liter | | Up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Chemistry Laboratory Parameters of Sodium, Potassium, Carbon-dioxide, Chloride, Glucose, Urea and Phosphate From Month 15 to Month 30 | Blood samples were collected to analyze the chemistry parameters: Sodium, potassium, carbon dioxide, chloride, glucose, urea and phosphate. | 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 | | Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Laboratory Parameters: Creatinine and Bilirubin From Month 15 to Month 30 | Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. | 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 | | Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Laboratory Parameters: ALT, ALP, AST, and Creatine Kinase From Month 15 to Month 30 | Blood samples were collected to analyze the chemistry parameters: ALT, AST, ALP and creatine kinase. | 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 | | Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Laboratory Parameter-glomerular Filtration Rate (GFR) From Creatinine Adjusted for Body Surface Area (BSA) From Month 15 to Month 30 | Blood samples were collected from participants to analyze the clinical chemistry parameter: GFR from Creatinine adjusted for BSA. | 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 | Milliliters/seconds/1.73 meter square | | Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Laboratory Parameter-Lipase From Month 15 to Month 30 | Blood samples were collected for the analysis of clinical chemistry parameter-Lipase. | 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 | | Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Secondary | Absolute Values of Clinical Laboratory Parameter-Albumin From Month 15 to Month 30 | Blood samples were collected for the analysis of clinical chemistry parameter-Albumin. | 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 | | Months 15, 18, 21, 24, 27, 30 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Other Pre-specified | Change From Baseline in Urinalysis Parameters: Urine Albumin to Creatinine Ratio | Urine samples were not planned to be collected for the analysis of urine albumin to creatinine ratio. The results for this outcome measure will never be posted. | Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted. | Posted | | | | | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Other Pre-specified | Change From Baseline in Urinalysis Parameters: Urine Protein to Creatinine Ratio | Urine samples were not planned to be collected for the analysis of urine protein to creatinine ratio. The results for this outcome measure will never be posted. | Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted. | Posted | | | | | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |
| Other Pre-specified | Change From Baseline in Urinalysis Parameters: Urine Phosphate | Urine samples were not planned to be collected for the analysis of urine phosphate. The results for this outcome measure will never be posted. | Safety population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted. | Posted | | | | | | Baseline and up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Participants With HIV Infection | In the Intervention Phase, participants with Human immunodeficiency virus (HIV) infection received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month. During Month 1, participants were administered 600 mg of CAB long-acting (LA) + 900 mg of RPV LA via intramuscular (IM) route. From Month 2, participants received 400 mg of CAB LA + 600 mg of RPV LA via IM route every month until Month 12. Participants continued CAB LA + RPV LA IM injection from Month 13 in the Extension Phase until it is commercially available. Participants were followed up for an additional 52 weeks if they discontinue the study treatment (after receiving at least 1 dose of CAB LA and /or RPV LA) and have started an alternative antiretroviral therapy (ART). |
| |