Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study

• ClinicalTrials.gov Identifier: NCT03639311
• Recruitment Status: Active, not recruiting
• First Posted: August 21, 2018
• Results First Posted: January 15, 2021
• Last Update Posted: March 22, 2021
• Sponsor: ViiV Healthcare
• Collaborator: Janssen, LP
• Information provided by (Responsible Party): ViiV Healthcare

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV Infections
• Interventions: Drug: CAB LA; Drug: RPV LA; Drug: RPV; Drug: DTG
• Enrollment: 97

Participant Flow

Recruitment Details	This was a multicenter, open-label, rollover study evaluating the efficacy, safety and tolerability of long acting (LA) cabotegravir (CAB) plus LA rilpivirine (RPV) administered every 2 months (Q2M) in human immunodeficiency virus-1 (HIV-1) adult participants who were virologically suppressed and participated in study LAI116482 (NCT01641809).
Pre-assignment Details	A total of 97 participants were enrolled in the study. The results presented are based on the Month 12 primary analysis. Data collection is still on-going and additional results will be provided after study completion analysis.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Period Title: Overall Study
Started	90	7
Completed	0	7
Not Completed	90	0
Reason Not Completed
Ongoing at the time of analysis	88	0
Lost to Follow-up	1	0
Adverse Event	1	0

Baseline Characteristics

Arm/Group Title		CAB LA + RPV LA Q2M	DTG + RPV	Total
Arm/Group Description		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.	Total of all reporting groups
Overall Number of Baseline Participants		90	7	97
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
Overall Study	Number Analyzed	90 participants	7 participants	97 participants
		41.2 (9.49)	49.1 (11.42)	41.7 (9.80)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	90 participants	7 participants	97 participants
	Female	2 2.2%	0 0.0%	2 2.1%
	Male	88 97.8%	7 100.0%	95 97.9%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	90 participants	7 participants	97 participants
American Indian or Alaska Native		1 1.1%	0 0.0%	1 1.0%
Asian-Japanese/East Asian/South East Asian Heritage		1 1.1%	0 0.0%	1 1.0%
Black or African American		21 23.3%	3 42.9%	24 24.7%
White		63 70.0%	4 57.1%	67 69.1%
Multiple		4 4.4%	0 0.0%	4 4.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12
Description	Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and DTG + RPV regimen in HIV-1 infected antiretroviral therapy (ART) experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Intent-to-treat-Exposed (ITT-E) Population comprised of all participants who received at least one dose of investigational product (IP) during on or after Day 1 visit. Participants were analyzed according to the selected treatment regardless of what treatment was actually received.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	90	7
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	0; (0.0 to 4.0)	0; (0.0 to 41.0)

2. Secondary Outcome

Title	Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12
Description	Percentage of participants with HIV-1 RNA <50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and oral DTG + RPV regimen. The HIV-1 RNA <50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	90	7
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	98; (95 to 100)	100; (59 to 100)

3. Secondary Outcome

Title	Percentage of Participants With Protocol-defined Confirmed Virologic Failure Overtime
Description	Confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 c/mL after prior suppression to <200 c/mL.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	90	7
Measure Type: Number; Unit of Measure: Percentage of participants
	0	0

4. Secondary Outcome

Title	Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm
Description	Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed	90
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Baseline (Day 1)	0; (0.0 to 4.0)
Month 2	0; (0.0 to 4.0)
Month 4	1; (0.0 to 3.3)
Month 6	0; (0.0 to 4.0)
Month 8	0; (0.0 to 4.0)
Month 10	0; (0.0 to 4.0)
Month 12	0; (0.0 to 4.0)

5. Secondary Outcome

Title	Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV
Description	Percentage of participants with HIV-1 RNA >=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of DTG + RPV regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA >=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Baseline (Day 1)	0.0; (0.0 to 41.0)
Month 3	0.0; (0.0 to 41.0)
Month 6	0.0; (0.0 to 41.0)
Month 9	0.0; (0.0 to 41.0)
Month 12	0.0; (0.0 to 41.0)

6. Secondary Outcome

Title	Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Log 10 copies per milliliter
Baseline (Day 1), n=89	Number Analyzed	89 participants
		1.591 (0.0085)
Month 2, n=90	Number Analyzed	90 participants
		1.590 (0.0000)
Month 4, n=89	Number Analyzed	89 participants
		1.594 (0.0305)
Month 6, n=89	Number Analyzed	89 participants
		1.590 (0.0042)
Month 8, n=89	Number Analyzed	89 participants
		1.590 (0.0000)
Month 10, n=88	Number Analyzed	88 participants
		1.594 (0.0384)
Month 12, n=88	Number Analyzed	88 participants
		1.590 (0.0000)

7. Secondary Outcome

Title	Absolute Values for HIV-1 RNA of DTG + RPV Arm
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population.

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Log 10 copies per milliliter
Baseline (Day 1)	1.590 (0.0000)
Month 3	1.590 (0.0000)
Month 6	1.590 (0.0000)
Month 9	1.590 (0.0000)
Month 12	1.590 (0.0000)

8. Secondary Outcome

Title	Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Log 10 copies per milliliter
Month 2, n=89	Number Analyzed	89 participants
		-0.001 (0.0085)
Month 4, n=88	Number Analyzed	88 participants
		0.003 (0.0299)
Month 6, n=88	Number Analyzed	88 participants
		-0.000 (0.0096)
Month 8, n=88	Number Analyzed	88 participants
		-0.001 (0.0085)
Month 10, n=87	Number Analyzed	87 participants
		0.003 (0.0396)
Month 12, n=87	Number Analyzed	87 participants
		-0.001 (0.0086)

9. Secondary Outcome

Title	Change From Baseline in HIV-1 RNA for DTG + RPV Arm
Description	Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Log 10 copies per milliliter
Month 3	0.000 (0.0000)
Month 6	0.000 (0.0000)
Month 9	0.000 (0.0000)
Month 12	0.000 (0.0000)

10. Secondary Outcome

Title	Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 2, 4, 6, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Cells per cubic millimeter
Baseline (Day 1), n=90	Number Analyzed	90 participants
		873.0 (233.37)
Month 2, n= 90	Number Analyzed	90 participants
		868.1 (261.49)
Month 4, n= 88	Number Analyzed	88 participants
		879.8 (280.88)
Month 6, n= 5	Number Analyzed	5 participants
		1046.8 (435.74)
Month 8, n= 88	Number Analyzed	88 participants
		857 (277.46)
Month 12, n= 88	Number Analyzed	88 participants
		859.2 (283.23)

11. Secondary Outcome

Title	Absolute Values for CD4+ for DTG + RPV Arm
Description	Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Cells per cubic millimeter
Baseline (Day 1)	804.3 (167.73)
Month 3	780.3 (145.22)
Month 6	728.9 (147.06)
Month 9	777.0 (251.37)
Month 12	790.4 (141.80)

12. Secondary Outcome

Title	Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 6, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Cells per cubic millimeter
Month 2, n= 90	Number Analyzed	90 participants
		-4.9 (196.47)
Month 4, n= 88	Number Analyzed	88 participants
		5.3 (221.68)
Month 6, n= 5	Number Analyzed	5 participants
		100.2 (343.66)
Month 8, n= 88	Number Analyzed	88 participants
		-20.7 (218.39)
Month 12, n= 88	Number Analyzed	88 participants
		-19.4 (189.19)

13. Secondary Outcome

Title	Change From Baseline Values for CD4+ for DTG + RPV Arm
Description	Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline value is defined as post-dose value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Cells per cubic millimeter
Month 3	-24.0 (118.40)
Month 6	-75.4 (123.71)
Month 9	-27.3 (150.96)
Month 12	-13.9 (145.76)

14. Secondary Outcome

Title	Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs)
Description	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all participants who received at least one dose of study treatment on or after Day 1 visit. Participants were assessed according to actual treatment received.
Time Frame	Up to Month 17

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	90	7
Measure Type: Count of Participants; Unit of Measure: Participants
Non-SAE (>=5%)	76 84.4%	3 42.9%
SAE	5 5.6%	0 0.0%

15. Secondary Outcome

Title	Number of Participants With Severity of Adverse Events
Description	Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).
Time Frame	Up to Month 17

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	90	7
Measure Type: Count of Participants; Unit of Measure: Participants
Grade 1	33 36.7%	0 0.0%
Grade 2	44 48.9%	3 42.9%
Grade 3	6 6.7%	0 0.0%
Grade 4	3 3.3%	0 0.0%
Grade 5	0 0.0%	0 0.0%

16. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Chemistry Toxicities
Description	Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotranferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	90	7
Measure Type: Count of Participants; Unit of Measure: Participants
ALT, Grade 1	8 8.9%	1 14.3%
ALT, Grade 2	4 4.4%	0 0.0%
ALT, Grade 3	1 1.1%	0 0.0%
ALT, Grade 4	0 0.0%	0 0.0%
AST, Grade 1	8 8.9%	0 0.0%
AST, Grade 2	3 3.3%	0 0.0%
AST, Grade 3	0 0.0%	0 0.0%
AST, Grade 4	0 0.0%	0 0.0%
Bilirubin, Grade 1	2 2.2%	0 0.0%
Bilirubin, Grade 2	1 1.1%	0 0.0%
Bilirubin, Grade 3	0 0.0%	0 0.0%
Bilirubin, Grade 4	0 0.0%	0 0.0%
CO2, Grade 1	8 8.9%	1 14.3%
CO2, Grade 2	0 0.0%	0 0.0%
CO2, Grade 3	0 0.0%	0 0.0%
CO2, Grade 4	0 0.0%	0 0.0%
Cholesterol, Grade 1	6 6.7%	0 0.0%
Cholesterol, Grade 2	4 4.4%	0 0.0%
Cholesterol, Grade 3	0 0.0%	0 0.0%
Cholesterol, Grade 4	0 0.0%	0 0.0%
Creatine kinase, Grade 1	5 5.6%	0 0.0%
Creatine kinase, Grade 2	2 2.2%	0 0.0%
Creatine kinase, Grade 3	4 4.4%	0 0.0%
Creatine kinase, Grade 4	2 2.2%	0 0.0%
Creatinine, Grade 1	1 1.1%	0 0.0%
Creatinine, Grade 2	0 0.0%	0 0.0%
Creatinine, Grade 3	0 0.0%	0 0.0%
Creatinine, Grade 4	0 0.0%	0 0.0%
Direct bilirubin, Grade 1	0 0.0%	0 0.0%
Direct bilirubin, Grade 2	0 0.0%	0 0.0%
Direct bilirubin, Grade 3	1 1.1%	0 0.0%
Direct bilirubin, Grade 4	0 0.0%	0 0.0%
GFR from creatinine adjusted using CKD-EPI, Grade 1	0 0.0%	0 0.0%
GFR from creatinine adjusted using CKD-EPI, Grade 2	12 13.3%	5 71.4%
GFR from creatinine adjusted using CKD-EPI, Grade 3	1 1.1%	1 14.3%
GFR from creatinine adjusted using CKD-EPI, Grade 4	0 0.0%	0 0.0%
GFR from creatinine adjusted for BSA, Grade 1	0 0.0%	0 0.0%
GFR from creatinine adjusted for BSA, Grade 2	12 13.3%	5 71.4%
GFR from creatinine adjusted for BSA, Grade 3	1 1.1%	1 14.3%
GFR from creatinine adjusted for BSA, Grade 4	0 0.0%	0 0.0%
Glucose, Grade 1	13 14.4%	1 14.3%
Glucose, Grade 2	12 13.3%	0 0.0%
Glucose, Grade 3	0 0.0%	0 0.0%
Glucose, Grade 4	0 0.0%	0 0.0%
LDL cholesterol calculation, Grade 1	6 6.7%	0 0.0%
LDL cholesterol calculation, Grade 2	3 3.3%	0 0.0%
LDL cholesterol calculation, Grade 3	0 0.0%	0 0.0%
LDL cholesterol calculation, Grade 4	0 0.0%	0 0.0%
Lipase, Grade 1	6 6.7%	0 0.0%
Lipase, Grade 2	5 5.6%	2 28.6%
Lipase, Grade 3	2 2.2%	0 0.0%
Lipase, Grade 4	1 1.1%	0 0.0%
Phosphate, Grade 1	6 6.7%	0 0.0%
Phosphate, Grade 2	1 1.1%	0 0.0%
Phosphate, Grade 3	0 0.0%	0 0.0%
Phosphate, Grade 4	0 0.0%	0 0.0%
Sodium, Grade 1	4 4.4%	0 0.0%
Sodium, Grade 2	0 0.0%	0 0.0%
Sodium, Grade 3	0 0.0%	0 0.0%
Sodium, Grade 4	0 0.0%	0 0.0%
Triglycerides, Grade 1	5 5.6%	0 0.0%
Triglycerides, Grade 2	4 4.4%	0 0.0%
Triglycerides, Grade 3	1 1.1%	0 0.0%
Triglycerides, Grade 4	1 1.1%	0 0.0%

17. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Hematology Toxicities
Description	The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	90	7
Measure Type: Count of Participants; Unit of Measure: Participants
Platelets, Grade 1	2 2.2%	0 0.0%
Platelets, Grade 2	0 0.0%	0 0.0%
Platelets, Grade 3	0 0.0%	0 0.0%
Platelets, Grade 4	0 0.0%	0 0.0%

18. Secondary Outcome

Title	Percentage of Participants Who Permanently Discontinued Treatment Due to Adverse Events
Description	An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Percentage of participants with adverse events leading to permanent withdrawal has been presented.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	90	7
Measure Type: Number; Unit of Measure: Percentage of participants
	1	0

19. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase Over Time for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: International units per liter
ALT, Month 2, n=90	Number Analyzed	90 participants
		-1.1 (16.99)
ALT, Month 4, n=89	Number Analyzed	89 participants
		-1.0 (26.15)
ALT, Month 8, n=89	Number Analyzed	89 participants
		0.0 (29.86)
ALT, Month 12, n=88	Number Analyzed	88 participants
		4.0 (44.62)
ALP, Month 2, n=90	Number Analyzed	90 participants
		0.2 (8.29)
ALP, Month 4, n=89	Number Analyzed	89 participants
		0.2 (14.20)
ALP, Month 8, n=89	Number Analyzed	89 participants
		2.0 (11.58)
ALP, Month 12, n=88	Number Analyzed	88 participants
		2.1 (12.39)
AST, Month 2, n=90	Number Analyzed	90 participants
		-5.6 (47.9)
AST, Month 4, n=89	Number Analyzed	89 participants
		-5.0 (50.5)
AST, Month 8, n=89	Number Analyzed	89 participants
		-5.3 (49.56)
AST, Month 12, n=88	Number Analyzed	88 participants
		-2.7 (54.93)
Creatine kinase, Month 2, n=90	Number Analyzed	90 participants
		-255.2 (2327.32)
Creatine kinase, Month 4, n=89	Number Analyzed	89 participants
		-204.0 (2483.41)
Creatine kinase, Month 8, n=89	Number Analyzed	89 participants
		-237.0 (2362.99)
Creatine kinase, Month 12, n=88	Number Analyzed	88 participants
		-252.0 (2429.86)

20. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase Over Time for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: International units per liter
ALT, Month 3	-0.7 (22.37)
ALT, Month 6	-4.3 (19.99)
ALT, Month 9	1.7 (8.16)
ALT, Month 12	-0.3 (32.32)
ALP, Month 3	1.4 (10.11)
ALP, Month 6	1.6 (8.04)
ALP, Month 9	-1.1 (11.74)
ALP, Month 12	10.0 (33.16)
AST, Month 3	-0.6 (10.61)
AST, Month 6	-3.3 (7.30)
AST, Month 9	-1.4 (6.68)
AST, Month 12	-0.6 (14.68)
Creatine kinase, Month 3	-66.6 (287.66)
Creatine kinase, Month 6	-107.9 (112.18)
Creatine kinase, Month 9	-90.6 (163.40)
Creatine kinase, Month 12	-134.0 (149.59)

21. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Grams per liter
Month 2, n=90	Number Analyzed	90 participants
		-0.8 (2.31)
Month 4, n=89	Number Analyzed	89 participants
		-0.9 (2.46)
Month 8, n=89	Number Analyzed	89 participants
		-0.8 (2.63)
Month 12, n=88	Number Analyzed	88 participants
		-0.9 (2.67)

22. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Albumin Over Time for DTG+ RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Grams per liter
Month 3	-1.6 (3.87)
Month 6	-1.4 (2.30)
Month 9	-1.3 (2.63)
Month 12	-2.6 (2.37)

23. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine Over Time for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
Bilirubin, Month 2, n=90	Number Analyzed	90 participants
		-1.0 (4.33)
Bilirubin, Month 4, n=89	Number Analyzed	89 participants
		-1.0 (5.14)
Bilirubin, Month 8, n=89	Number Analyzed	89 participants
		-1.0 (4.83)
Bilirubin, Month 12, n=88	Number Analyzed	88 participants
		-0.5 (4.35)
Creatinine, Month 2, n=90	Number Analyzed	90 participants
		-1.84 (7.121)
Creatinine, Month 4, n=89	Number Analyzed	89 participants
		-1.70 (9.393)
Creatinine, Month 8, n=89	Number Analyzed	89 participants
		-0.98 (7.977)
Creatinine, Month 12, n=88	Number Analyzed	88 participants
		-1.14 (9.204)

24. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine Over Time for DTG+ RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
Bilirubin, Month 3, n=7	-1.7 (4.23)
Bilirubin, Month 6, n=7	-1.4 (3.21)
Bilirubin, Month 9, n=7	-0.9 (2.54)
Bilirubin, Month 12, n=7	-1.4 (3.78)
Creatinine, Month 3, n=7	11.89 (8.89)
Creatinine, Month 6, n=7	8.36 (4.419)
Creatinine, Month 9, n=7	16.56 (10.131)
Creatinine, Month 12, n=7	7.47 (7.328)

25. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Millimoles per liter
Carbon dioxide, Month 2, n=90	Number Analyzed	90 participants
		-0.4 (1.86)
Carbon dioxide, Month 4, n=89	Number Analyzed	89 participants
		-0.1 (2.00)
Carbon dioxide, Month 8, n=89	Number Analyzed	89 participants
		-0.2 (2.22)
Carbon dioxide, Month 12, n=88	Number Analyzed	88 participants
		-0.7 (2.18)
Chloride, Month 2, n=90	Number Analyzed	90 participants
		1.0 (2.06)
Chloride, Month 4, n=89	Number Analyzed	89 participants
		1.1 (2.20)
Chloride, Month 8, n=89	Number Analyzed	89 participants
		1.2 (2.07)
Chloride, Month 12, n=88	Number Analyzed	88 participants
		1.0 (2.24)
Glucose, Month 2, n=64	Number Analyzed	64 participants
		0.32 (0.568)
Glucose, Month 4, n=62	Number Analyzed	62 participants
		0.42 (0.684)
Glucose, Month 8, n=62	Number Analyzed	62 participants
		0.47 (0.842)
Glucose, Month 12, n=87	Number Analyzed	87 participants
		0.32 (0.662)
Phosphate, Month 2, n=90	Number Analyzed	90 participants
		-0.00 (0.176)
Phosphate, Month 4, n=89	Number Analyzed	89 participants
		-0.00 (0.191)
Phosphate, Month 8, n=89	Number Analyzed	89 participants
		-0.02 (0.206)
Phosphate, Month 12, n=88	Number Analyzed	88 participants
		-0.02 (0.199)
Potassium, Month 2, n=90	Number Analyzed	90 participants
		0.06 (0.392)
Potassium, Month 4, n=89	Number Analyzed	89 participants
		-0.02 (0.450)
Potassium, Month 8, n=89	Number Analyzed	89 participants
		0.05 (0.408)
Potassium, Month 12, n=88	Number Analyzed	88 participants
		0.06 (0.375)
Sodium, Month 2, n=90	Number Analyzed	90 participants
		0.2 (1.84)
Sodium, Month 4, n=89	Number Analyzed	89 participants
		0.6 (2.10)
Sodium, Month 8, n=89	Number Analyzed	89 participants
		0.6 (1.96)
Sodium, Month 12, n=88	Number Analyzed	88 participants
		0.2 (1.88)
Urea, Month 2, n=90	Number Analyzed	90 participants
		0.13 (1.253)
Urea, Month 4, n=89	Number Analyzed	89 participants
		-0.06 (1.346)
Urea, Month 8, n=89	Number Analyzed	89 participants
		0.28 (1.131)
Urea, Month 12, n=88	Number Analyzed	88 participants
		-0.11 (1.318)

26. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		DTG + RPV
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed		7
Mean (Standard Deviation); Unit of Measure: Millimoles per liter
Carbon dioxide, Month 3, n=7	Number Analyzed	7 participants
		-1.0 (1.53)
Carbon dioxide, Month 6, n=7	Number Analyzed	7 participants
		-1.7 (1.50)
Carbon dioxide, Month 9, n=7	Number Analyzed	7 participants
		-1.9 (2.85)
Carbon dioxide, Month 12, n=7	Number Analyzed	7 participants
		-1.9 (2.48)
Chloride, Month 3, n=7	Number Analyzed	7 participants
		1.0 (1.83)
Chloride, Month 6, n=7	Number Analyzed	7 participants
		1.7 (2.14)
Chloride, Month 9, n=7	Number Analyzed	7 participants
		1.0 (0.82)
Chloride, Month 12, n=7	Number Analyzed	7 participants
		1.0 (2.08)
Glucose, Month 3, n=5	Number Analyzed	5 participants
		0.08 (0.259)
Glucose, Month 6, n=5	Number Analyzed	5 participants
		0.16 (0.483)
Glucose, Month 9, n=4	Number Analyzed	4 participants
		0.15 (0.700)
Glucose, Month 12, n=7	Number Analyzed	7 participants
		0.07 (0.55)
Phosphate, Month 3, n=7	Number Analyzed	7 participants
		0.02 (0.131)
Phosphate, Month 6, n=7	Number Analyzed	7 participants
		0.08 (0.177)
Phosphate, Month 9, n=7	Number Analyzed	7 participants
		0.05 (0.178)
Phosphate, Month 12, n=7	Number Analyzed	7 participants
		-0.05 (0.101)
Potassium, Month 3, n=7	Number Analyzed	7 participants
		-0.26 (0.378)
Potassium, Month 6, n=7	Number Analyzed	7 participants
		-0.03 (0.250)
Potassium, Month 9, n=7	Number Analyzed	7 participants
		0.01 (0.135)
Potassium, Month 12, n=7	Number Analyzed	7 participants
		-0.06 (0.257)
Sodium, Month 3, n=7	Number Analyzed	7 participants
		0.1 (1.68)
Sodium, Month 6, n=7	Number Analyzed	7 participants
		-0.9 (0.90)
Sodium, Month 9, n=7	Number Analyzed	7 participants
		-1.0 (2.58)
Sodium, Month 12, n=7	Number Analyzed	7 participants
		-1.1 (1.07)
Urea, Month 3, n=7	Number Analyzed	7 participants
		1.43 (0.732)
Urea, Month 6, n=7	Number Analyzed	7 participants
		1.14 (1.144)
Urea, Month 9, n=7	Number Analyzed	7 participants
		1.86 (1.994)
Urea, Month 12, n=7	Number Analyzed	7 participants
		0.71 (0.756)

27. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein (HDL) Cholesterol Direct, Low Density Lipoprotein (LDL) Cholesterol Calculation, LDL Cholesterol Direct and Triglycerides for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: cholesterol, direct HDL cholesterol, LDL cholesterol calculation, direct LDL cholesterol and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Millimoles per liter
Cholesterol, n=88	Number Analyzed	88 participants
		0.12 (0.760)
Direct HDL cholesterol, n=88	Number Analyzed	88 participants
		-0.05 (0.224)
LDL cholesterol calculation, n=83	Number Analyzed	83 participants
		0.10 (0.718)
Direct LDL cholesterol, n=2	Number Analyzed	2 participants
		0.21 (0.367)
Triglycerides, n=88	Number Analyzed	88 participants
		0.28 (1.965)

28. Secondary Outcome

Title	Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameters: cholesterol, HDL cholesterol direct, LDL cholesterol calculation, LDL cholesterol direct and triglycerides.
Time Frame	At Day 1

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		DTG + RPV
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed		7
Mean (Standard Deviation); Unit of Measure: Millimoles per liter
Cholesterol, n=7	Number Analyzed	7 participants
		4.88 (1.352)
Direct HDL cholesterol, n=7	Number Analyzed	7 participants
		1.59 (0.258)
LDL cholesterol calculation, n=6	Number Analyzed	6 participants
		2.29 (0.52)
Direct LDL cholesterol, n=1	Number Analyzed	1 participants
		4.45 [1] (NA)
Triglycerides, n=7	Number Analyzed	7 participants
		1.52 (1.493)

[1]

Standard deviation could not be calculated for single participant.

29. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Milliliter per minute per 1.73 meter^2
Month 2, n=90	Number Analyzed	90 participants
		1.9 (7.70)
Month 4, n=89	Number Analyzed	89 participants
		1.7 (10.09)
Month 8, n=88	Number Analyzed	88 participants
		0.8 (8.63)
Month 12, n=88	Number Analyzed	88 participants
		0.3 (10.32)

30. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Milliliter per minute per 1.73 meter^2
Month 3	-11.7 (10.83)
Month 6	-7.4 (4.28)
Month 9	-16.6 (12.27)
Month 12	-7.3 (8.71)

31. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Milliliter per second per 1.73 meter^2
Month 2, n=90	Number Analyzed	90 participants
		0.03 (0.128)
Month 4, n=89	Number Analyzed	89 participants
		0.02 (0.168)
Month 8, n=88	Number Analyzed	88 participants
		0.01 (0.143)
Month 12, n=88	Number Analyzed	88 participants
		0.00 (0.172)

32. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Milliliter per second per 1.73 meter^2
Month 3	-0.19 (0.180)
Month 6	-0.12 (0.071)
Month 9	-0.27 (0.204)
Month 12	-0.12 (0.145)

33. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Units per liter
Month 2, n=90	Number Analyzed	90 participants
		-0.1 (29.11)
Month 4, n=89	Number Analyzed	89 participants
		3.7 (47.68)
Month 8, n=89	Number Analyzed	89 participants
		-1.3 (29.43)
Month 12, n=88	Number Analyzed	88 participants
		-2.9 (36.83)

34. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Units per liter
Month 3	2.6 (6.90)
Month 6	4.4 (4.35)
Month 9	1.3 (6.85)
Month 12	26.0 (49.76)

35. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA + RPV LA Q2M
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed	88
Mean (Standard Deviation); Unit of Measure: Ratio
	0.20 (1.698)

36. Secondary Outcome

Title	Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for DTG + RPV Arm
Description	Blood samples were collected for the analysis of clinical chemical parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Month 6

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	2
Mean (Standard Deviation); Unit of Measure: Ratio
	0.55 (0.679)

37. Secondary Outcome

Title	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Basophils, Month 2, n=85	Number Analyzed	85 participants
		-0.000 (0.02200)
Basophils, Month 4, n=82	Number Analyzed	82 participants
		0.009 (0.02913)
Basophils, Month 8, n=86	Number Analyzed	86 participants
		0.003 (0.02524)
Basophils, Month 12, n=86	Number Analyzed	86 participants
		-0.003 (0.02501)
Eosinophils, Month 2, n=85	Number Analyzed	85 participants
		0.017 (0.11886)
Eosinophils, Month 4, n=82	Number Analyzed	82 participants
		0.004 (0.12341)
Eosinophils, Month 8, n=86	Number Analyzed	86 participants
		0.003 (0.14555)
Eosinophils, Month 12, n=86	Number Analyzed	86 participants
		-0.000 (0.13671)
Leukocytes, Month 2, n=85	Number Analyzed	85 participants
		-0.054 (1.1875)
Leukocytes, Month 4, n=82	Number Analyzed	82 participants
		0.276 (1.4416)
Leukocytes, Month 8, n=86	Number Analyzed	86 participants
		0.257 (1.4252)
Leukocytes, Month 12, n=86	Number Analyzed	86 participants
		-0.153 (1.1961)
Lymphocytes, Month 2, n=88	Number Analyzed	88 participants
		0.196 (0.49569)
Lymphocytes, Month 4, n=86	Number Analyzed	86 participants
		0.178 (0.52066)
Lymphocytes, Month 8, n=86	Number Analyzed	86 participants
		0.139 (0.50957)
Lymphocytes, Month 12, n=86	Number Analyzed	86 participants
		0.021 (0.60569)
Monocytes, Month 2, n=85	Number Analyzed	85 participants
		0.022 (0.11715)
Monocytes, Month 4, n=82	Number Analyzed	82 participants
		0.048 (0.14689)
Monocytes, Month 8, n=86	Number Analyzed	86 participants
		0.026 (0.16979)
Monocytes, Month 12, n=86	Number Analyzed	86 participants
		-0.021 (0.15241)
Neutrophils, Month 2, n=85	Number Analyzed	85 participants
		-0.197 (0.99349)
Neutrophils, Month 4, n=82	Number Analyzed	82 participants
		0.056 (1.19574)
Neutrophils, Month 8, n=86	Number Analyzed	86 participants
		0.120 (1.18605)
Neutrophils, Month 12, n=86	Number Analyzed	86 participants
		-0.134 (1.03311)
Platelets, Month 2, n=82	Number Analyzed	82 participants
		3.77 (23.389)
Platelets, Month 4, n=81	Number Analyzed	81 participants
		5.40 (30.889)
Platelets, Month 8, n=84	Number Analyzed	84 participants
		3.74 (24.695)
Platelets, Month 12, n=84	Number Analyzed	84 participants
		1.14 (32.005)

38. Secondary Outcome

Title	Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm
Description	Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: 10^9 cells per liter
Basophils, Month 3	-0.008 (0.01464)
Basophils, Month 6	-0.010 (0.02309)
Basophils, Month 9	-0.005 (0.01512)
Basophils, Month 12	-0.010 (0.01732)
Eosinophils, Month 3	-0.072 (0.16307)
Eosinophils, Month 6	-0.057 (0.11236)
Eosinophils, Month 9	-0.051 (0.10040)
Eosinophils, Month 12	-0.030 (0.17127)
Leukocytes, Month 3	0.014 (0.7669)
Leukocytes, Month 6	-0.386 (0.8355)
Leukocytes, Month 9	0.014 (1.3508)
Leukocytes, Month 12	-0.057 (0.9343)
Lymphocytes, Month 3	0.053 (0.43811)
Lymphocytes, Month 6	-0.019 (0.35435)
Lymphocytes, Month 9	0.085 (0.59379)
Lymphocytes, Month 12	-0.001 (0.39121)
Monocytes, Month 3	0.098 (0.08877)
Monocytes, Month 6	0.020 (0.07211)
Monocytes, Month 9	-0.021 (0.06644)
Monocytes, Month 12	0.004 (0.07435)
Neutrophils, Month 3	0.097 (0.47612)
Neutrophils, Month 6	-0.295 (0.64143)
Neutrophils, Month 9	0.115 (1.20803)
Neutrophils, Month 12	-0.034 (0.80715)
Platelets, Month 3	-1.00 (18.841)
Platelets, Month 6	-12.57 (35.298)
Platelets, Month 9	-21.29 (61.372)
Platelets, Month 12	-2.86 (47.544)

39. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Femtoliters
Month 2, n=85	Number Analyzed	85 participants
		-1.07 (1.731)
Month 4, n=82	Number Analyzed	82 participants
		-2.04 (2.186)
Month 8, n=86	Number Analyzed	86 participants
		-1.42 (2.527)
Month 12, n=86	Number Analyzed	86 participants
		-1.28 (2.528)

40. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm
Description	Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Femtoliters
Month 3	-1.00 (1.000)
Month 6	0.14 (1.574)
Month 9	0.29 (1.704)
Month 12	-0.14 (1.952)

41. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: 10^12 cells per liter
Month 2, n=85	Number Analyzed	85 participants
		-0.064 (0.2773)
Month 4, n=82	Number Analyzed	82 participants
		-0.021 (0.3185)
Month 8, n=86	Number Analyzed	86 participants
		-0.085 (0.3164)
Month 12, n=86	Number Analyzed	86 participants
		-0.063 (0.3279)

42. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm
Description	Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: 10^12 cells per liter
Month 3	-0.114 (0.1464)
Month 6	-0.171 (0.1113)
Month 9	-0.171 (0.1704)
Month 12	-0.143 (0.0976)

43. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Proportion of red blood cells in blood
Month 2, n=85	Number Analyzed	85 participants
		-0.011 (0.02762)
Month 4, n=82	Number Analyzed	82 participants
		-0.012 (0.02935)
Month 8, n=86	Number Analyzed	86 participants
		-0.015 (0.02809)
Month 12, n=86	Number Analyzed	86 participants
		-0.011 (0.02760)

44. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm
Description	Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Proportion of red blood cells in blood
Month 3	-0.015 (0.01516)
Month 6	-0.013 (0.01287)
Month 9	-0.013 (0.01332)
Month 12	-0.013 (0.01491)

45. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm
Description	Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.
Overall Number of Participants Analyzed		90
Mean (Standard Deviation); Unit of Measure: Grams per liter
Month 2, n=85	Number Analyzed	85 participants
		-2.11 (8.801)
Month 4, n=82	Number Analyzed	82 participants
		-1.57 (9.433)
Month 8, n=86	Number Analyzed	86 participants
		-3.29 (8.542)
Month 12, n=86	Number Analyzed	86 participants
		-3.19 (8.814)

46. Secondary Outcome

Title	Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm
Description	Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 3, 6, 9 and 12

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: Grams per liter
Month 3	-3.57 (6.554)
Month 6	-4.29 (2.928)
Month 9	-4.86 (3.891)
Month 12	-4.57 (5.062)

47. Secondary Outcome

Title	Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio
Description	Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.
Time Frame	At Day 1

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed		90	7
Mean (Standard Deviation); Unit of Measure: Ratio
Urine albumin/creatinine ratio, n=68, 5	Number Analyzed	68 participants	5 participants
		0.7 (0.980)	0.4 (0.122)
Urine protein/creatinine ratio, n=73, 5	Number Analyzed	73 participants	5 participants
		7.6 (4.528)	9.1 (7.237)

48. Secondary Outcome

Title	Absolute Values of Urine Creatinine
Description	Urine samples were collected for the analysis of urine creatinine.
Time Frame	At Day 1

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	90	7
Mean (Standard Deviation); Unit of Measure: Micromoles per liter
	14875.6 (9267.95)	12112.9 (7186.16)

49. Secondary Outcome

Title	Absolute Values of Urine Phosphate
Description	Urine samples were collected for the analysis of urine phosphate.
Time Frame	At Day 1

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	90	7
Mean (Standard Deviation); Unit of Measure: Millimoles per liter
	18.2 (15.306)	14.7 (6.917)

50. Secondary Outcome

Title	Absolute Values of Urine Specific Gravity
Description	Urine samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.
Time Frame	At Day 1

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at specified time points has been presented.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	89	7
Mean (Standard Deviation); Unit of Measure: Ratio
	1.0 (0.007)	1.0 (0.007)

51. Secondary Outcome

Title	Absolute Values of Urine Potential of Hydrogen (pH)
Description	Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Time Frame	At Day 1

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at specified time points has been presented.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	89	7
Mean (Standard Deviation); Unit of Measure: pH
	6.1 (0.739)	6.5 (0.345)

52. Secondary Outcome

Title	Number of Participants With Treatment Emergent Genotypic Resistance
Description	Plasma samples were collected and analyzed for genotypic resistance from participants who met confirmed virologic withdrawal criteria.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants reporting confirmed virologic failure were analyzed.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

53. Secondary Outcome

Title	Number of Participants With Treatment Emergent Phenotypic Resistance
Description	Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.
Time Frame	Up to Month 12

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants reporting confirmed virologic failure were analyzed.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

54. Secondary Outcome

Title	Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV)
Description	HIVDQoL includes 2 overview items and 26 domain items. The 2 overview items: Item 1: 3(excellent) to -3(extremely bad); Higher score indicates better quality of life. Item 2: -3(very much better) to 1(worse); Lower score indicates better quality of life. The Weighted impact score was calculated for 26 individual domain items by multiplying impact score (-3[maximum negative impact] to +1[maximum positive impact] by the corresponding importance score (3 [very important] to 0[not all important]). Average Weighted impact (AWI) score was calculated by summing individual weighted impact scores and dividing by the number of domain items. The ranges of weighted impact score and average impact score were from -9(maximum negative impact) to +3(maximum positive impact); higher score indicates positive impact. Change from Baseline was defined as post-dose visit value minus Baseline value (latest pre-treatment assessment with a non-missing value).
Time Frame	Baseline (Day 1) and at Months 6 and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed		90	7
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Overview Item 1, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.1 (0.65)	0.4 (0.53)
Overview Item 1, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		0.0 (0.75)	-0.1 (0.38)
Overview Item 2, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.0 (1.11)	0.3 (1.25)
Overview Item 2, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		0.2 (1.05)	-0.6 (1.13)
Leisure, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.1 (2.20)	0.9 (1.46)
Leisure, Month 12, n=87, 7	Number Analyzed	87 participants	7 participants
		0.2 (2.02)	-1.6 (3.74)
Work, Month 6, n=86, 7	Number Analyzed	86 participants	7 participants
		-0.3 (2.07)	-0.9 (4.14)
Work, Month 12, n=84, 7	Number Analyzed	84 participants	7 participants
		-0.1 (2.48)	-0.7 (2.75)
Holiday, Month 6, n=84, 7	Number Analyzed	84 participants	7 participants
		-0.5 (2.24)	-0.3 (3.55)
Holiday, Month 12, n=84, 5	Number Analyzed	84 participants	5 participants
		-0.1 (2.76)	-2.0 (2.83)
Getting out and about, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.0 (1.83)	-1.1 (3.76)
Getting out and about, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.2 (2.01)	-1.9 (2.48)
Long journey, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.3 (2.24)	-0.4 (2.70)
Long journey, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		0.4 (2.45)	-2.3 (2.93)
Do Physically, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-0.2 (2.09)	-0.7 (2.36)
Do Physically, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.3 (2.39)	-1.7 (2.63)
Family, Month 6, n=83, 7	Number Analyzed	83 participants	7 participants
		-0.1 (1.38)	-0.9 (2.27)
Family, Month 12, n=82, 6	Number Analyzed	82 participants	6 participants
		-0.3 (2.30)	-1.5 (2.51)
Friends, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-0.7 (1.93)	-1.1 (2.85)
Friends, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.3 (2.57)	-2.0 (2.38)
Go on dates, Month 6, n=62, 2	Number Analyzed	62 participants	2 participants
		-0.4 (2.04)	-3.5 (3.54)
Go on dates, Month 12, n=60, 2	Number Analyzed	60 participants	2 participants
		-0.2 (3.11)	-3.5 (3.54)
Close relationships, Month 6, n=71, 6	Number Analyzed	71 participants	6 participants
		0.4 (3.10)	-0.5 (2.95)
Close relationships, Month 12, n=68, 6	Number Analyzed	68 participants	6 participants
		0.2 (3.13)	-0.5 (2.95)
Sex life, Month 6, n=80, 6	Number Analyzed	80 participants	6 participants
		0.2 (2.74)	-1.3 (2.80)
Sex life, Month 12, n=80, 5	Number Analyzed	80 participants	5 participants
		-0.2 (2.62)	-1.0 (3.00)
Physical appearance, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-0.3 (1.78)	-1.1 (2.85)
Physical appearance, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.2 (2.28)	-1.4 (2.23)
Self-confidence, Month 6, n=88, 7	Number Analyzed	88 participants	7 participants
		0.0 (2.35)	-1.7 (2.43)
Self-confidence, Month 12, n=86, 7	Number Analyzed	86 participants	7 participants
		0.2 (2.83)	-2.9 (3.48)
Motivation, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-0.3 (2.04)	-0.6 (2.51)
Motivation, Month 12, n=86, 7	Number Analyzed	86 participants	7 participants
		-0.3 (2.85)	-2.1 (2.85)
Stigma, Month 6, n=40, 0	Number Analyzed	40 participants	0 participants
		-1.1 (2.38)
Stigma, Month 12, n=38, 1	Number Analyzed	38 participants	1 participants
		0.0 (3.03)	-2.0 [1] (NA)
Conceal, Month 6, n=55, 5	Number Analyzed	55 participants	5 participants
		-0.6 (2.91)	-1.6 (3.51)
Conceal, Month 12, n=55, 5	Number Analyzed	55 participants	5 participants
		0.3 (3.04)	-0.4 (4.10)
Feelings About the Future, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.0 (2.89)	1.0 (2.24)
Feelings About the Future, Month 12, n=87, 7	Number Analyzed	87 participants	7 participants
		0.3 (3.02)	-0.9 (2.85)
Financial Situation, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-0.1 (2.76)	1.1 (1.46)
Financial Situation, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.1 (2.59)	-0.6 (4.61)
Depend on Others, Month 6, n=37, 4	Number Analyzed	37 participants	4 participants
		-0.4 (3.11)	0.0 (0.00)
Depend on Others, Month 12, n=35, 6	Number Analyzed	35 participants	6 participants
		-0.2 (2.73)	-1.2 (3.25)
Others Fuss or Worry, Month 6, n=42, 5	Number Analyzed	42 participants	5 participants
		0.0 (3.00)	-1.6 (3.36)
Others Fuss or Worry, Month 12, n=35, 6	Number Analyzed	35 participants	6 participants
		0.1 (3.21)	-0.3 (3.50)
Freedom to Eat, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.0 (1.98)	-1.3 (3.40)
Freedom to Eat, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		0.1 (2.62)	-1.1 (2.48)
Freedom to Drink, Month 6, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.2 (1.81)	-0.7 (4.42)
Freedom to Drink, Month 12, n=87, 7	Number Analyzed	87 participants	7 participants
		-0.1 (2.47)	-1.7 (3.40)
Spiritual/Religious Life, Month 6, n=46, 6	Number Analyzed	46 participants	6 participants
		-0.1 (2.46)	-0.5 (1.22)
Spiritual/Religious Life, Month 12, n=45, 6	Number Analyzed	45 participants	6 participants
		-0.1 (1.14)	-1.0 (2.45)
Feelings About the Past, Month 6, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.3 (2.69)	0.7 (2.21)
Feelings About the Past, Month 12, n=87, 7	Number Analyzed	87 participants	7 participants
		0.0 (2.74)	-1.3 (2.21)
Having Children or More Children, Month 6, n=30, 4	Number Analyzed	30 participants	4 participants
		0.3 (1.86)	1.3 (4.27)
Having Children or More Children, Month 12,n=35, 4	Number Analyzed	35 participants	4 participants
		-0.3 (2.82)	-1.5 (3.00)
Sleep, Month 6, n=87, 7	Number Analyzed	87 participants	7 participants
		-0.2 (2.32)	0.7 (1.25)
Sleep, Month 12, n=87, 7	Number Analyzed	87 participants	7 participants
		0.0 (2.56)	-0.4 (2.70)
Average Weighted Impact, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-0.17 (1.084)	-0.43 (1.792)
Average Weighted Impact, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.07 (1.690)	-1.27 (1.695)

[1]

Standard deviation could not be calculated for single participant.

55. Secondary Outcome

Title	Change From Baseline in Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)
Description	HIVTSQs total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame	Baseline (Day 1) and at Months 6 and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed		90	7
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-0.19 (6.419)	0.71 (3.773)
Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.42 (6.659)	0.14 (6.256)

56. Secondary Outcome

Title	Change From Baseline in Individual Item Score of HIVTSQs
Description	HIVTSQs is a 12 item questionnaire. The individual item scores are rated as 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. Change from Baseline is defined as post-dose value minus Baseline value. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits.
Time Frame	Baseline (Day 1) and at Months 6 and 12

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

Arm/Group Title		CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed		90	7
Mean (Standard Deviation); Unit of Measure: Scores on a scale
Item 1, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-0.1 (0.82)	0.0 (0.00)
Item 1, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.1 (0.75)	-0.1 (0.38)
Item 2, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-0.1 (0.46)	-0.3 (0.49)
Item 2, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		0.0 (0.34)	-0.1 (0.38)
Item 3, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-0.5 (1.41)	0.1 (0.38)
Item 3, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.5 (1.21)	-0.1 (0.38)
Item 4, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.0 (0.95)	0.0 (0.00)
Item 4, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		0.1 (0.93)	0.1 (0.69)
Item 5, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.1 (1.00)	0.3 (0.49)
Item 5, Month 12, n=87, 7	Number Analyzed	87 participants	7 participants
		0.1 (1.14)	0.1 (0.38)
Item 6, Month 6, n=88, 7	Number Analyzed	88 participants	7 participants
		0.1 (1.13)	0.4 (1.62)
Item 6, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		0.0 (1.31)	0.3 (1.80)
Item 7, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.1 (0.74)	0.0 (0.58)
Item 7, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		0.0 (1.06)	0.1 (0.69)
Item 8, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.2 (0.93)	0.0 (0.58)
Item 8, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		0.1 (0.95)	0.0 (0.58)
Item 9, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-0.1 (0.61)	0.0 (0.00)
Item 9, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		-0.2 (0.80)	-0.1 (0.38)
Item 10, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.1 (0.91)	0.3 (0.76)
Item 10, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		0.1 (1.03)	0.1 (0.90)
Item 11, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		0.0 (1.09)	-0.1 (0.38)
Item 11, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		0.1 (0.79)	-0.1 (0.90)
Item 12, Month 6, n=89, 7	Number Analyzed	89 participants	7 participants
		-1.3 (1.59)	-0.6 (1.13)
Item 12, Month 12, n=88, 7	Number Analyzed	88 participants	7 participants
		-1.1 (1.58)	-0.1 (0.38)

57. Secondary Outcome

Title	Change in Treatment Satisfaction Over Time Using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc)
Description	HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores represented deterioration in satisfaction with treatment. A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores were imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and remain missing.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	CAB LA + RPV LA Q2M	DTG + RPV
Arm/Group Description:	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
Overall Number of Participants Analyzed	88	7
Mean (Standard Deviation); Unit of Measure: Scores on a scale
	28.0 (6.78)	27.7 (6.97)

58. Other Pre-specified Outcome

Title	Plasma Trough Concentration (Ctrough) for CAB LA
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of CAB LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary population pharmacokinetic (Pop PK) analyses were not conducted.
Time Frame	Pre-dose (Day 1) and Month 12

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population

Arm/Group Title	CAB LA
Arm/Group Description:	Participants in this arm received their first dose CAB LA (600 mg) injection within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injection (CAB LA 600 mg) occurring Q2M thereafter.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

59. Other Pre-specified Outcome

Title	Ctrough for RPV LA
Description	Blood samples were collected at indicated time points for pharmacokinetic analysis of RPV LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary Pop PK analyses were not conducted.
Time Frame	Pre-dose (Day 1) and Month 12

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population

Arm/Group Title	RPV LA
Arm/Group Description:	Participants in this arm received their first dose RPV LA (900 mg) injection within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injection (RPV LA 900 mg) occurring Q2M thereafter.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	Non-SAEs and SAEs were collected from Day 1 and up to Month 17
Adverse Event Reporting Description	Non-SAEs and SAEs were collected in Safety Population.
Arm/Group Title	CAB LA + RPV LA Q2M		DTG + RPV
Arm/Group Description	Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. Participants remained on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and/or RPV LA.		Eligible participants from LAI116482 (NCT01641809 [LATTE]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12. Participants continued to receive the treatment until the study intervention was locally approved and commercially available.
All-Cause Mortality
	CAB LA + RPV LA Q2M		DTG + RPV
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/90 (0.00%)		0/7 (0.00%)
Serious Adverse Events
	CAB LA + RPV LA Q2M		DTG + RPV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/90 (5.56%)		0/7 (0.00%)
Gastrointestinal disorders
Proctitis † 1	1/90 (1.11%)	1	0/7 (0.00%)	0
General disorders
Injection site extravasation † 1	1/90 (1.11%)	1	0/7 (0.00%)	0
Hepatobiliary disorders
Cholecystitis acute † 1	1/90 (1.11%)	1	0/7 (0.00%)	0
Cholelithiasis † 1	1/90 (1.11%)	1	0/7 (0.00%)	0
Infections and infestations
Anal abscess † 1	1/90 (1.11%)	1	0/7 (0.00%)	0
Orchitis † 1	1/90 (1.11%)	1	0/7 (0.00%)	0
Urinary tract infection bacterial † 1	1/90 (1.11%)	1	0/7 (0.00%)	0
1 Term from vocabulary, MedDRA 22.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	CAB LA + RPV LA Q2M		DTG + RPV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	76/90 (84.44%)		3/7 (42.86%)
Gastrointestinal disorders
Diarrhoea † 1	9/90 (10.00%)	13	0/7 (0.00%)	0
Haemorrhoids † 1	5/90 (5.56%)	5	0/7 (0.00%)	0
Nausea † 1	5/90 (5.56%)	5	0/7 (0.00%)	0
Abdominal pain † 1	2/90 (2.22%)	3	1/7 (14.29%)	1
General disorders
Injection site pain † 1	67/90 (74.44%)	414	0/7 (0.00%)	0
Injection site discomfort † 1	10/90 (11.11%)	20	0/7 (0.00%)	0
Pyrexia † 1	9/90 (10.00%)	20	0/7 (0.00%)	0
Fatigue † 1	6/90 (6.67%)	16	0/7 (0.00%)	0
Injection site nodule † 1	5/90 (5.56%)	6	0/7 (0.00%)	0
Injection site swelling † 1	5/90 (5.56%)	11	0/7 (0.00%)	0
Hepatobiliary disorders
Hepatic steatosis † 1	0/90 (0.00%)	0	1/7 (14.29%)	1
Infections and infestations
Nasopharyngitis † 1	10/90 (11.11%)	10	0/7 (0.00%)	0
Upper respiratory tract infection † 1	10/90 (11.11%)	11	0/7 (0.00%)	0
Syphilis † 1	6/90 (6.67%)	6	0/7 (0.00%)	0
Injury, poisoning and procedural complications
Muscle strain † 1	1/90 (1.11%)	1	1/7 (14.29%)	1
Nervous system disorders
Headache † 1	6/90 (6.67%)	7	1/7 (14.29%)	1
Respiratory, thoracic and mediastinal disorders
Cough † 1	5/90 (5.56%)	5	0/7 (0.00%)	0
Skin and subcutaneous tissue disorders
Erythema † 1	0/90 (0.00%)	0	1/7 (14.29%)	1
1 Term from vocabulary, MedDRA 22.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

• Name/Title: GSK Response Center
• Organization: ViiV Healthcare
• Phone: 866-435-7343
• EMail: GSKClinicalSupportHD@gsk.com

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT03639311
• Other Study ID Numbers: 209035
• First Submitted: August 10, 2018
• First Posted: August 21, 2018
• Results First Submitted: November 20, 2020
• Results First Posted: January 15, 2021
• Last Update Posted: March 22, 2021