| Primary | Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q8W | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. | Sub-study pharmacokinetic (PK) parameter Population included all participants who received at least one CAB and/or RPV thigh injection and had at least one evaluable PK parameter estimate during the sub-study. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | | Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q8W First Thigh Injection | Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q8W Last Thigh Injection | Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase. | | OG002 | CAB+RPV Q8W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.67± 69.3
- OG0011.61± 55.5
- OG0021.81± 51.6
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Ratio of geometric least square mean | 0.926 | | | 2-Sided | 90 | 0.831 | 1.03 | | | | | Other | | | | | | | | |
|
| Primary | Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q8W | Blood samples were collected for PK analysis. | Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q8W First Thigh Injection | Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q8W Last Thigh Injection | Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase. | | OG002 | CAB+RPV Q8W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase. |
|
| Primary | Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q8W | Blood samples were collected for PK analysis. | Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | | Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q8W First Thigh Injection | Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q8W Last Thigh Injection | Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase. | | OG002 | CAB+RPV Q8W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase. |
|
| Primary | Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q8W | Blood samples were collected for PK analysis. | Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q8W First Thigh Injection | Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q8W Last Thigh Injection | Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase. | | OG002 | CAB+RPV Q8W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase. |
|
| Primary | Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q8W | Blood samples were collected for PK analysis. | Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*microgram/milliliter | | Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q8W First Thigh Injection | Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q8W Last Thigh Injection | Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase. | | OG002 | CAB+RPV Q8W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase. |
|
| Primary | Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q8W | Blood samples were collected for PK analysis. | Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram/milliliter | | Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q8W First Thigh Injection | Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q8W Last Thigh Injection | Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase. | | OG002 | CAB+RPV Q8W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase. |
|
| Primary | Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q4W | Blood samples were collected for PK analysis. | Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | | Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q4W First Thigh Injection | Participants received a first IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q4W Last Thigh Injection | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Week 12 during Thigh Injection Phase. | | OG002 | CAB+RPV Q4W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Pre-Thigh Gluteal Injection Phase. |
|
| Primary | Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q4W | Blood samples were collected for PK analysis. | Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q4W First Thigh Injection | Participants received a first IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q4W Last Thigh Injection | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Week 12 during Thigh Injection Phase. | | OG002 | CAB+RPV Q4W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Pre-Thigh Gluteal Injection Phase. |
|
| Primary | Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q4W | Blood samples were collected for PK analysis. | Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | | Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q4W First Thigh Injection | Participants received a first IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q4W Last Thigh Injection | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Week 12 during Thigh Injection Phase. | | OG002 | CAB+RPV Q4W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Pre-Thigh Gluteal Injection Phase. |
|
| Primary | Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q4W | Blood samples were collected for PK analysis. | Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | | Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q4W First Thigh Injection | Participants received a first IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q4W Last Thigh Injection | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Week 12 during Thigh Injection Phase. | | OG002 | CAB+RPV Q4W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Pre-Thigh Gluteal Injection Phase. |
|
| Primary | Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q4W | Blood samples were collected for PK analysis. | Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hours*micrograms per milliliter | | Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q4W First Thigh Injection | Participants received a first IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q4W Last Thigh Injection | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Week 12 during Thigh Injection Phase. | | OG002 | CAB+RPV Q4W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Pre-Thigh Gluteal Injection Phase. |
|
| Primary | Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q4W | Blood samples were collected for PK analysis. | Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*nanogram per milliliter | | Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection) | | | | ID | Title | Description |
|---|
| OG000 | CAB+RPV Q4W First Thigh Injection | Participants received a first IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase. | | OG001 | CAB+RPV Q4W Last Thigh Injection | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Week 12 during Thigh Injection Phase. | | OG002 | CAB+RPV Q4W Pre-Thigh Gluteal Injection | Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Pre-Thigh Gluteal Injection Phase. |
|
| Secondary | Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Severity of ISRs was analyzed using division of acquired immunodeficiency syndrome (DAIDS) grading scale. The severity is categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Death. Higher grade indicates more severe condition. Data for number of participants with maximum grade or intensity for overall ISRs were reported. | Sub-study Safety Population included all randomized participants who received at least one CAB and/or RPV thigh injection. Only those participants with data available at specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W. |
|
| Secondary | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity of AESI was analyzed using DAIDS grading scale. The severity is categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Death. Higher grade indicates more severe condition. Data for number of participants with common AESI based on maximum severity were reported. | Sub-study Safety Population. Only those participants with data available at specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | |
|
| Secondary | Number of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to ISRs and AESIs is presented. | Sub-study Safety Population | Posted | | Count of Participants | | Participants | | Up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W. |
|
| Secondary | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (Copies/mL) Using the Food and Drug (FDA) Snapshot Algorithm-Thigh Injection Phase | Percentage of participants with plasma HIV-1 RNA < 50 copies/mL was obtained using the FDA snapshot algorithm. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded off. | Sub-study Intent-to-treat Exposed Population included all randomized participants who received at least one CAB and/or RPV thigh injection. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline (Day 1) and at Weeks 4, 8, 12, 16 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W. |
|
| Secondary | Percentage of Participants With Plasma HIV RNA Greater Than or Equal to (>=)50 Copies/mL Over Time as Per the FDA Snapshot Algorithm- Thigh Injection Phase | Percentage of participants with plasma HIV 1 RNA >= 50 copies/mL was obtained using the FDA snapshot algorithm. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded off. | Sub-study Intent-to-Treat Exposed Population | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline (Day 1) and at Weeks 4, 8, 12, 16 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W. |
|
| Secondary | Percentage of Participants With Protocol-defined Confirmed Virologic Failure (CVF)- Thigh Injection Phase | Plasma samples were collected for quantitative analysis of HIV-1 RNA. CVF was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL. Percentage of participants with protocol-defined CVF were reported. | Sub-study Intent-to-treat Exposed Population | Posted | | Number | | Percentage of participants | | Up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W. |
|
| Secondary | Number of Participants With Treatment Emergent Genotypic Resistance - Thigh Injection Phase | 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 treatment emergent genotypic resistance were reported. | Sub-study Confirmed Virologic Failure Population comprised of all participants who received at least one CAB and/or RPV thigh injection who met Confirmed Virologic Failure (CVF) criteria in the sub-study. Only participants with CVF were included in the analysis. | Posted | | | | | | Up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W. |
|
| Secondary | Number of Participants With Treatment Emergent Phenotypic Resistance - Thigh Injection Phase | 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 treatment emergent phenotypic resistance were reported. | Sub-study Confirmed Virologic Failure Population. Only participants with CVF were included in the analysis. | Posted | | | | | | Up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W. |
|
| Secondary | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections. | Sub-study Intent-to-Treat Exposed Population | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during thigh injection phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the return to gluteal injection phase and subsequent gluteal injection occurred after Q4W. |
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| Secondary | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase | A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections. | Sub-study Intent-to-Treat Exposed Population. Only those participants with data available at specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Week 8 | | | | ID | Title | Description |
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| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during thigh injection phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the return to gluteal injection phase and subsequent gluteal injection occurred after Q8W. |
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| Secondary | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase | A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections. | Sub-study Intent-to-Treat Exposed Population. Only those participants with data available at specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during thigh injection phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the return to gluteal injection phase and subsequent gluteal injection occurred after Q4W. |
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| Secondary | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included two questions regarding the maximum level of pain experienced with the most recent injections. | Sub-study Intent-to-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Count of Participants | | Participants | | Study Week 16 | | | | ID | Title | Description |
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| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W. |
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| Secondary | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points-Thigh Injection Phase | HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicate dissatisfaction. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. | Sub-study intent-to-treat exposed Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline (Day 1) and Week 16 | | | | ID | Title | Description |
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| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W. |
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| Secondary | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm -Return to Gluteal Injection Phase | HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicate dissatisfaction. | Sub-study intent-to-treat exposed Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Study Week 24 | | | | ID | Title | Description |
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| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. |
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| Secondary | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm -Return to Gluteal Injection Phase | HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicate dissatisfaction. | Sub-study intent-to-treat exposed Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Study Week 20 | | | | ID | Title | Description |
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| OG000 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during thigh injection phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the return to gluteal injection phase and subsequent gluteal injection occurred after Q4W. |
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| Secondary | Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase | HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6(very satisfied) to 0(very dissatisfied).Higher scores represent greater satisfaction.Data was reported for each treatment satisfaction item based on(Item1=satisfaction with current treatment,Item2=level of HIV control based on treatment,Item3=any side effects of present treatment,Item4=demands made by current treatment,Item5=convenience in finding treatment,Item6=flexibility in finding treatment,Item7=understanding HIV,Item8=extent to which the treatment fits in with lifestyle, Item9=recommendation of present treatment to someone else,Item10=continuation with present form of treatment,Item11=easy or difficult treatment,Item12=amount of discomfort/pain involved with present form of treatment).Baseline was latest pre-treatment assessment with a non-missing value, including those from unscheduled visits.Change from Baseline was calculated by subtracting Baseline value from post-dose visit value. | Sub-study Intent-to-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline (Day 1) and up to Week 16 | | | | ID | Title | Description |
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| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. |
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| Secondary | Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection | HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction with each aspect of treatment. Data was reported for each treatment satisfaction item based on (Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment). Change from Study Week 16 to Study Week 24 was calculated by subtracting the Study Week 16 value from the Study Week 24 value. | Sub-study intent-to-treat exposed Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Study Week 16 and Study Week 24 | | | | ID | Title | Description |
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| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. |
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| Secondary | Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase | HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6(very satisfied) to 0(very dissatisfied).Higher scores represent greater satisfaction.Data was reported for each treatment satisfaction item based on(Item1=satisfaction with current treatment,Item2=level of HIV control based on treatment,Item3=any side effects of present treatment,Item4=demands made by current treatment,Item5=convenience in finding treatment,Item6=flexibility in finding treatment,Item7=understanding HIV,Item8=extent to which the treatment fits in with lifestyle, Item9=recommendation of present treatment to someone else,Item10=continuation with present form of treatment,Item11=easy or difficult treatment,Item12=amount of discomfort/pain involved with present form of treatment).Change from Study Week 16 to Study Week 20 was calculated by subtracting the Study Week 16 value from the Study Week 20 value. | Sub-study Intent-To-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Study Week 16 and Study Week 20 | | | | ID | Title | Description |
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| OG000 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during thigh injection phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the return to gluteal injection phase and subsequent gluteal injection occurred after Q4W. |
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| Secondary | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Total Score at Indicated Time Points- Thigh Injection Phase | HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change. | Sub-study Intent-To-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Up to Week 16 | | | | ID | Title | Description |
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| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. | | OG001 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W. |
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| Secondary | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | HIVTSQc is a 12-item questionnaire to measure treatment satisfaction in HIV participants. Individual items were rated as +3 (much more satisfied) to -3 (much less satisfied). Higher the score, greater the improvement in satisfaction with each aspect of treatment and lower the score, greater the deterioration in satisfaction with each aspect of treatment. Data was reported for each treatment satisfaction item based on (Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment). | Sub-study Intent-To-Treat exposed Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Up to Week 16 | | | | ID | Title | Description |
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| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. |
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| Secondary | Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q8W Arm | A preference questionnaire was used to assess participant's preference for the thigh injections compared with the gluteal injections. The "Preference" questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated "Which injection site do you prefer". The responses included Injections in the buttock, Injections in the thigh and No preference. | Sub-study Intent-To-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Count of Participants | | Participants | | Up to Study Week 24 | | | | ID | Title | Description |
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| OG000 | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) | Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W. |
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| Secondary | Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q4W Arm | A preference questionnaire was used to assess participant's preference for the thigh injections compared with the gluteal injections. The "Preference" questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated "Which injection site do you prefer". The responses included Injections in the buttock, Injections in the thigh, Other and No preference. | Sub-study Intent-To-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed. | Posted | | Count of Participants | | Participants | | Up to Study Week 20 | | | | ID | Title | Description |
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| OG000 | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during thigh injection phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at Week 16) of CAB LA 400 mg + RPV LA 600 mg during the return to gluteal injection phase and subsequent gluteal injection occurred after Q4W. |
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