Trial Outcomes & Findings for Open-Label Multi-Centre Randomised Switch Study to Evaluate Virological Efficacy Over 96Weeks Of 2-Drug Therapy With Dolutegravir(DTG)/Rilpivirine(RPV) Fixed Dose Combination(FDC) in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With NNRTI Mutation K103N (NCT NCT05349838)

NCT ID: NCT05349838

Last Updated: 2024-12-24

Results Overview

Virological Suppression is defined as \<50 copies/ml HIV RNA

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 140 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2024-12-24

Participant Flow

Participants were recruited at 32 medical centres across Europe. The first participant was enrolled in November 2018 and the last participant was enrolled in December 2020.

Of 176 participants that were screened for the study, 140 met eligibility criteria and were randomised to the study.

Participant milestones

Measure	DTG/RPV FDC Regimen One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Overall Study STARTED	95	45
Overall Study Per-protocol Population at Week 48	87	40
Overall Study COMPLETED	83	36
Overall Study NOT COMPLETED	12	9

Reasons for withdrawal

Measure	DTG/RPV FDC Regimen One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Overall Study Virological Failure	1	2
Overall Study Withdrawal by Subject	2	3
Overall Study Adverse Event	3	1
Overall Study Lost to Follow-up	1	2
Overall Study Other reasons	5	1

Baseline Characteristics

Data was not collected for one participant

Baseline characteristics by cohort

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Total n=140 Participants Total of all reporting groups
Age, Continuous	52 years n=95 Participants	53 years n=45 Participants	52 years n=140 Participants
Sex: Female, Male Female	16 Participants n=95 Participants	10 Participants n=45 Participants	26 Participants n=140 Participants
Sex: Female, Male Male	79 Participants n=95 Participants	35 Participants n=45 Participants	114 Participants n=140 Participants
Race/Ethnicity, Customized Ethnicity N(%) · White caucasian	69 Participants n=95 Participants	29 Participants n=45 Participants	98 Participants n=140 Participants
Race/Ethnicity, Customized Ethnicity N(%) · White mixed	2 Participants n=95 Participants	1 Participants n=45 Participants	3 Participants n=140 Participants
Race/Ethnicity, Customized Ethnicity N(%) · Asian	4 Participants n=95 Participants	0 Participants n=45 Participants	4 Participants n=140 Participants
Race/Ethnicity, Customized Ethnicity N(%) · Black	7 Participants n=95 Participants	7 Participants n=45 Participants	14 Participants n=140 Participants
Race/Ethnicity, Customized Ethnicity N(%) · African	3 Participants n=95 Participants	3 Participants n=45 Participants	6 Participants n=140 Participants
Race/Ethnicity, Customized Ethnicity N(%) · Caribbean	1 Participants n=95 Participants	1 Participants n=45 Participants	2 Participants n=140 Participants
Race/Ethnicity, Customized Ethnicity N(%) · Other	9 Participants n=95 Participants	4 Participants n=45 Participants	13 Participants n=140 Participants
Region of Enrollment Belgium	6 participants n=95 Participants	3 participants n=45 Participants	9 participants n=140 Participants
Region of Enrollment United Kingdom	36 participants n=95 Participants	16 participants n=45 Participants	52 participants n=140 Participants
Region of Enrollment Italy	7 participants n=95 Participants	3 participants n=45 Participants	10 participants n=140 Participants
Region of Enrollment France	23 participants n=95 Participants	13 participants n=45 Participants	36 participants n=140 Participants
Region of Enrollment Germany	8 participants n=95 Participants	2 participants n=45 Participants	10 participants n=140 Participants
Region of Enrollment Spain	15 participants n=95 Participants	7 participants n=45 Participants	22 participants n=140 Participants
Region of Enrollment Ireland	0 participants n=95 Participants	1 participants n=45 Participants	1 participants n=140 Participants
Body Mass Index (BMI) (kg/m^2)	24.3 kg/m^2 n=95 Participants	26.4 kg/m^2 n=45 Participants	25.1 kg/m^2 n=140 Participants
Drinks alchohol	52 Participants n=95 Participants	25 Participants n=45 Participants	77 Participants n=140 Participants
Current smoker	34 Participants n=95 Participants	12 Participants n=45 Participants	46 Participants n=140 Participants
Uses recreational drugs	15 Participants n=95 Participants	7 Participants n=45 Participants	22 Participants n=140 Participants
Hypertension	14 Participants n=95 Participants	8 Participants n=45 Participants	22 Participants n=140 Participants
Diabetes	6 Participants n=95 Participants	4 Participants n=45 Participants	10 Participants n=140 Participants
Hepatitis C IgG antibodies	9 Participants n=95 Participants	3 Participants n=45 Participants	12 Participants n=140 Participants
Hepatitis B core antibodies	28 Participants n=95 Participants	17 Participants n=45 Participants	45 Participants n=140 Participants
Hepatitis B surface antibodies	80 Participants n=95 Participants	36 Participants n=45 Participants	116 Participants n=140 Participants
HIV Information Years since HIV diagnosis	17.1 years n=95 Participants	22.4 years n=45 Participants	19.7 years n=140 Participants
HIV Information Years on ART	16 years n=95 Participants	17.7 years n=45 Participants	16.5 years n=140 Participants
ART at enrolment Nucleoside Reverse Transcriptase Inhibitor (NRTI) regimen	72 Participants n=95 Participants	36 Participants n=45 Participants	108 Participants n=140 Participants
ART at enrolment Tenofovir-DF (TDF) / Emtrictabine	25 Participants n=95 Participants	7 Participants n=45 Participants	32 Participants n=140 Participants
ART at enrolment Tenofovir-AF (TDF) / Emtrictabine	22 Participants n=95 Participants	15 Participants n=45 Participants	37 Participants n=140 Participants
ART at enrolment Abcavir/Lamivudine	17 Participants n=95 Participants	8 Participants n=45 Participants	25 Participants n=140 Participants
ART at enrolment Other	8 Participants n=95 Participants	5 Participants n=45 Participants	13 Participants n=140 Participants
ART at enrolment PI regimen	60 Participants n=95 Participants	27 Participants n=45 Participants	87 Participants n=140 Participants
ART at enrolment Darunavir	50 Participants n=95 Participants	22 Participants n=45 Participants	72 Participants n=140 Participants
ART at enrolment Atazanavir	8 Participants n=95 Participants	5 Participants n=45 Participants	13 Participants n=140 Participants
ART at enrolment Lopinavir	1 Participants n=95 Participants	0 Participants n=45 Participants	1 Participants n=140 Participants
ART at enrolment Amprenavir	1 Participants n=95 Participants	0 Participants n=45 Participants	1 Participants n=140 Participants
ART at enrolment Integrase Strand Transfer Inhibitor (INSTI) regimen	46 Participants n=95 Participants	21 Participants n=45 Participants	67 Participants n=140 Participants
ART at enrolment Raltegravir	16 Participants n=95 Participants	7 Participants n=45 Participants	23 Participants n=140 Participants
ART at enrolment Dolutegravir	20 Participants n=95 Participants	8 Participants n=45 Participants	28 Participants n=140 Participants
ART at enrolment Bictegravir	3 Participants n=95 Participants	1 Participants n=45 Participants	4 Participants n=140 Participants
ART at enrolment Elvitegravir	7 Participants n=95 Participants	5 Participants n=45 Participants	12 Participants n=140 Participants
ART at enrolment Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) regimen	7 Participants n=95 Participants	6 Participants n=45 Participants	13 Participants n=140 Participants
ART at enrolment Etravirine	6 Participants n=95 Participants	4 Participants n=45 Participants	10 Participants n=140 Participants
ART at enrolment Rilpivirine	1 Participants n=95 Participants	2 Participants n=45 Participants	3 Participants n=140 Participants
History of HIV-1 resistance mutations Total number of drug resistance mutations according to IAS 2019	3 Number of mutations n=95 Participants	4 Number of mutations n=45 Participants	3 Number of mutations n=140 Participants
History of HIV-1 resistance mutations Total number of NRTI drug resistance mutations according to IAS 2019	1 Number of mutations n=95 Participants	1 Number of mutations n=45 Participants	1 Number of mutations n=140 Participants
History of HIV-1 resistance mutations Total number of NNRTI drug resistance mutations according to IAS 2019	1 Number of mutations n=95 Participants	1 Number of mutations n=45 Participants	1 Number of mutations n=140 Participants
History of HIV-1 resistance mutations Total number of PI drug resistance mutations according to IAS 2019	0 Number of mutations n=95 Participants	1 Number of mutations n=45 Participants	1 Number of mutations n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Leu100Ile	0 Participants n=95 Participants	0 Participants n=45 Participants	0 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Lys101Glu/Pro	0 Participants n=95 Participants	0 Participants n=45 Participants	0 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Val106Ala/Ile/Met/Thr	1 Participants n=95 Participants	3 Participants n=45 Participants	4 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Val108Ile	7 Participants n=95 Participants	4 Participants n=45 Participants	11 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Glu138Ala/Gly/Lys/Gln/Arg	0 Participants n=95 Participants	0 Participants n=45 Participants	0 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Val179Asp/Phe/Thr/Leu	2 Participants n=95 Participants	1 Participants n=45 Participants	3 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Tyr181Cys/Ile/Val	0 Participants n=95 Participants	0 Participants n=45 Participants	0 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Tyr188Cys/His/Leu	0 Participants n=95 Participants	0 Participants n=45 Participants	0 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Gly190Ala/Ser/Glu	0 Participants n=95 Participants	0 Participants n=45 Participants	0 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations His221Tyr	3 Participants n=95 Participants	0 Participants n=45 Participants	3 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Pro225His	7 Participants n=95 Participants	1 Participants n=45 Participants	8 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Phe227Cys/Leu/Arg	1 Participants n=95 Participants	0 Participants n=45 Participants	1 Participants n=140 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Met230Ile/Leu	0 Participants n=95 Participants	0 Participants n=45 Participants	0 Participants n=140 Participants
CD4 CD8 cell count per uL CD4+ count	629 cells/uL n=94 Participants • Data was not collected for one participant	660 cells/uL n=45 Participants • Data was not collected for one participant	650 cells/uL n=139 Participants • Data was not collected for one participant
CD4 CD8 cell count per uL CD8+ count	720 cells/uL n=94 Participants • Data was not collected for one participant	790 cells/uL n=45 Participants • Data was not collected for one participant	753 cells/uL n=139 Participants • Data was not collected for one participant
Cd4 Cd8 % CD4+	33 % above versus below 350 cells/μL n=95 Participants	31 % above versus below 350 cells/μL n=45 Participants	32 % above versus below 350 cells/μL n=140 Participants
Cd4 Cd8 % CD8+	39 % above versus below 350 cells/μL n=95 Participants	39 % above versus below 350 cells/μL n=45 Participants	39 % above versus below 350 cells/μL n=140 Participants

PRIMARY outcome

Timeframe: 48 weeks

Virological Suppression is defined as <50 copies/ml HIV RNA

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Number of Participants With and Without Virological Suppression HIV RNA < 50 copies/mL	84 Participants	40 Participants
Number of Participants With and Without Virological Suppression HIV RNA >= 50 copies/mL	3 Participants	1 Participants
Number of Participants With and Without Virological Suppression No virologic data at week 48	8 Participants	4 Participants

SECONDARY outcome

Timeframe: week 96

Virological Suppression is defined as <50 copies/ml HIV RNA

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Number of Participants With and Without Virological Suppression HIV RNA < 50 copies/mL	80 Participants	33 Participants
Number of Participants With and Without Virological Suppression HIV RNA >= 50 copies/mL	5 Participants	3 Participants
Number of Participants With and Without Virological Suppression No virologic data at week 96	10 Participants	9 Participants

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Population: Only 93 out of the 95 subjects randomised to the experimental arm (DTG/RPV FDC Regimen) had Red Blood Cell values recorded at baseline. This is the reason the participants analyzed in this category differs from the Participant Flow

red blood cell count evaluation

Outcome measures

Measure	DTG/RPV FDC Regimen n=93 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Blood Cell Counts - Red Blood Cells Change from baseline to week 48	0.20 Red Blood Cells 10^12/L Standard Error 0.06	-0.07 Red Blood Cells 10^12/L Standard Error 0.09
Changes in Blood Cell Counts - Red Blood Cells Change from week 48 to week 96	-0.02 Red Blood Cells 10^12/L Standard Error 0.07	0.19 Red Blood Cells 10^12/L Standard Error 0.10
Changes in Blood Cell Counts - Red Blood Cells Change from baseline to week 96	0.17 Red Blood Cells 10^12/L Standard Error 0.09	0.12 Red Blood Cells 10^12/L Standard Error 0.13

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

white blood cell count evaluation

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Blood Cell Counts - White Blood Cells Change from baseline to week 48	-0.08 White Blood Cells 10^12/L Standard Error 0.26	-0.06 White Blood Cells 10^12/L Standard Error 0.38
Changes in Blood Cell Counts - White Blood Cells Change from week 48 to week 96	0.09 White Blood Cells 10^12/L Standard Error 0.27	-0.03 White Blood Cells 10^12/L Standard Error 0.41
Changes in Blood Cell Counts - White Blood Cells Change from baseline to week 96	0.01 White Blood Cells 10^12/L Standard Error 0.34	-0.09 White Blood Cells 10^12/L Standard Error 0.51

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

platelet count evaluation

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Blood Cell Counts - Platelets Change from baseline to week 48	3.4 Platelets 10^9/L Standard Error 8.2	-2.6 Platelets 10^9/L Standard Error 12.1
Changes in Blood Cell Counts - Platelets Change from week 48 to week 96	0.6 Platelets 10^9/L Standard Error 8.6	9.3 Platelets 10^9/L Standard Error 13.1
Changes in Blood Cell Counts - Platelets Change from baseline to week 96	4.0 Platelets 10^9/L Standard Error 11.1	6.7 Platelets 10^9/L Standard Error 16.8

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Haemoglobin count evaluation

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Blood Cell Counts - Haemoglobin Change from baseline to week 48	0.1 g/dL Standard Error 0.2	0 g/dL Standard Error 0.3
Changes in Blood Cell Counts - Haemoglobin Change from week 48 to week 96	0 g/dL Standard Error 0.2	0.2 g/dL Standard Error 0.3
Changes in Blood Cell Counts - Haemoglobin Change from baseline to week 96	0.1 g/dL Standard Error 0.3	0.2 g/dL Standard Error 0.4

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Change from baseline in Sodium

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Change From Baseline in Sodium Change from baseline to week 48	0.3 mmol/L Standard Error 0.3	-0.8 mmol/L Standard Error 0.4
Change From Baseline in Sodium Change from week 48 to week 96	-0.5 mmol/L Standard Error 0.3	0.3 mmol/L Standard Error 0.4
Change From Baseline in Sodium Change from baseline to week 96	-0.2 mmol/L Standard Error 0.3	-0.5 mmol/L Standard Error 0.5

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Liver level evaluation - bilirubin

Outcome measures

Measure	DTG/RPV FDC Regimen n=94 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Liver Levels - Bilirubin Change from baseline to week 48	-0.6 umol/L Standard Error 1.4	-1.9 umol/L Standard Error 2.0
Changes in Liver Levels - Bilirubin Change from week 48 to week 96	-1.3 umol/L Standard Error 1.4	-2.2 umol/L Standard Error 2.2
Changes in Liver Levels - Bilirubin Change from baseline to week 96	-1.9 umol/L Standard Error 1.4	-4.1 umol/L Standard Error 2.1

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Liver level evaluation - ALT

Outcome measures

Measure	DTG/RPV FDC Regimen n=93 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Liver Levels - Alanine Aminotransferase (ALT) Change from baseline to week 48	2.4 U/L Standard Error 3.2	-0.6 U/L Standard Error 4.7
Changes in Liver Levels - Alanine Aminotransferase (ALT) Change from week 48 to week 96	-0.7 U/L Standard Error 3.4	1.1 U/L Standard Error 5.1
Changes in Liver Levels - Alanine Aminotransferase (ALT) Change from baseline to week 96	1.8 U/L Standard Error 3.7	0.6 U/L Standard Error 5.6

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Renal markers evaluation- creatinine clearance (eGFR)

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=44 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Renal Markers - Creatinine Clearance (Estimated Glomerular Filtration Rate(eGFR)) Change from baseline to week 48	-1.7 eGFR mL/min Standard Error 2.2	-1.3 eGFR mL/min Standard Error 3.3
Changes in Renal Markers - Creatinine Clearance (Estimated Glomerular Filtration Rate(eGFR)) Change from week 48 to week 96	-1.2 eGFR mL/min Standard Error 2.3	-3.4 eGFR mL/min Standard Error 3.6
Changes in Renal Markers - Creatinine Clearance (Estimated Glomerular Filtration Rate(eGFR)) Change from baseline to week 96	-2.9 eGFR mL/min Standard Error 2.8	-4.7 eGFR mL/min Standard Error 4.2

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Change from baseline in Glucose

Outcome measures

Measure	DTG/RPV FDC Regimen n=93 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=43 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Change From Baseline in Glucose Change from baseline to week 48	-0.15 mmol/L Standard Error 0.16	-0.06 mmol/L Standard Error 0.23
Change From Baseline in Glucose Change from week 48 to week 96	0.09 mmol/L Standard Error 0.17	-0.11 mmol/L Standard Error 0.25
Change From Baseline in Glucose Change from baseline to week 96	-0.06 mmol/L Standard Error 0.21	-0.17 mmol/L Standard Error 0.31

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Renal markers evaluation - creatinine

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=44 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Renal Markers - Creatinine Change from baseline to week 48	3.0 umol/L Standard Error 2.3	0.3 umol/L Standard Error 3.4
Changes in Renal Markers - Creatinine Change from week 48 to week 96	0.3 umol/L Standard Error 2.4	5.5 umol/L Standard Error 3.7
Changes in Renal Markers - Creatinine Change from baseline to week 96	3.3 umol/L Standard Error 3.1	5.8 umol/L Standard Error 4.7

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Bone markers evaluation - Alkaline phosphatase

Outcome measures

Measure	DTG/RPV FDC Regimen n=94 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Bone Markers - Alkaline Phosphatase Change from baseline to week 48	-5.3 U/L Standard Error 3.0	-1.5 U/L Standard Error 4.3
Changes in Bone Markers - Alkaline Phosphatase Change from week 48 to week 96	3.1 U/L Standard Error 3.1	-2.5 U/L Standard Error 4.7
Changes in Bone Markers - Alkaline Phosphatase Change from baseline to week 96	-2.2 U/L Standard Error 4.0	-4.0 U/L Standard Error 6.0

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Fasting lipids level evaluation - total cholesterol

Outcome measures

Measure	DTG/RPV FDC Regimen n=93 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Fasting Lipids From Baseline - Total Cholesterol Change from baseline to week 48	-0.09 mmol/L Standard Error 0.14	0.05 mmol/L Standard Error 0.2
Changes in Fasting Lipids From Baseline - Total Cholesterol Change from week 48 to week 96	0.02 mmol/L Standard Error 0.15	-0.19 mmol/L Standard Error 0.22
Changes in Fasting Lipids From Baseline - Total Cholesterol Change from baseline to week 96	-0.07 mmol/L Standard Error 0.18	-0.13 mmol/L Standard Error 0.27

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Fasting lipids level evaluation - HDL

Outcome measures

Measure	DTG/RPV FDC Regimen n=93 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=44 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Fasting Lipids From Baseline - High Density Lipoprotein (HDL) Change from baseline to week 48	0.06 mmol/L Standard Error 0.05	0.03 mmol/L Standard Error 0.07
Changes in Fasting Lipids From Baseline - High Density Lipoprotein (HDL) Change from week 48 to week 96	-0.03 mmol/L Standard Error 0.05	0.01 mmol/L Standard Error 0.08
Changes in Fasting Lipids From Baseline - High Density Lipoprotein (HDL) Change from baseline to week 96	0.03 mmol/L Standard Error 0.06	0.04 mmol/L Standard Error 0.1

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Questionnaire (EQ-5D-3L) Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression are recorded on 3 point scale (tick boxes), which indicates the severity of problems the participant has with each of these activities. Patients will select No problems, Some problems or Extreme problems/Unable to perform. Patients also report their current Health State on a Scale from 1 to 100 on which the best state you can imagine is marked 100 and the worst state you can imagine is marked 0.

Outcome measures

Measure	DTG/RPV FDC Regimen n=93 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=43 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Quality of Life Health Status Score Change from baseline to week 48	1.7 score on a scale Standard Error 2.9	6.3 score on a scale Standard Error 4.3
Changes in Quality of Life Health Status Score Change from week 48 to week 96	-2.0 score on a scale Standard Error 3.0	-7.2 score on a scale Standard Error 4.6
Changes in Quality of Life Health Status Score Change from baseline to week 96	-0.3 score on a scale Standard Error 3.3	-0.9 score on a scale Standard Error 5.0

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

HIV Treatment Satisfaction Questionnaire (HIVTSQs) Answers are recorded on a scale from 0 to 6, with 0 being least satisfied and 6 being most satisfied.

Outcome measures

Measure	DTG/RPV FDC Regimen n=94 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Patient Satisfaction - HIV Treatment Satisfaction Questionnaire (HIVTSQs) Change from baseline to week 48	1.6 Global satisfaction score Standard Error 0.6	0.7 Global satisfaction score Standard Error 0.9
Changes in Patient Satisfaction - HIV Treatment Satisfaction Questionnaire (HIVTSQs) Change from week 48 to week 96	0.2 Global satisfaction score Standard Error 0.6	0.4 Global satisfaction score Standard Error 1.0
Changes in Patient Satisfaction - HIV Treatment Satisfaction Questionnaire (HIVTSQs) Change from baseline to week 96	1.8 Global satisfaction score Standard Error 0.7	1.1 Global satisfaction score Standard Error 1.1

SECONDARY outcome

Timeframe: Baseline to week 48

Adverse Events reports (AEs, SAEs and treatment discontinuation)

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Number of Participants With Adverse Events - Baseline to Week 48 AEs leading to study drug interruption	4 Participants	0 Participants
Number of Participants With Adverse Events - Baseline to Week 48 Any Adverse Events (AEs)	78 Participants	33 Participants
Number of Participants With Adverse Events - Baseline to Week 48 Grade 1	61 Participants	25 Participants
Number of Participants With Adverse Events - Baseline to Week 48 Grade 2	43 Participants	13 Participants
Number of Participants With Adverse Events - Baseline to Week 48 Grade 3-4	7 Participants	2 Participants
Number of Participants With Adverse Events - Baseline to Week 48 Missing grade	6 Participants	1 Participants
Number of Participants With Adverse Events - Baseline to Week 48 Drug related AEs	22 Participants	0 Participants
Number of Participants With Adverse Events - Baseline to Week 48 Drug related grade 3-4 AEs	1 Participants	0 Participants
Number of Participants With Adverse Events - Baseline to Week 48 SAEs	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, week 24, week 48, week 96

Population: Interaction between DTG or RPV and co-medication. For the Continued ART Regimen Group, baseline looks at interaction between ARV treatment at baseline and co-medication and Week 24 is N/A

Comparing the drug interaction outcomes between antiretroviral therapy and co-medications before and after the switch by using the www.hiv-druginteractions.org/ website (within the same study arm)

Outcome measures

Measure	DTG/RPV FDC Regimen n=90 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Number of Drug Drug Interactions Baseline	1 Number of Drug Interactions Interval 0.0 to 2.0	1 Number of Drug Interactions Interval 0.0 to 3.0
Number of Drug Drug Interactions Week 24	1 Number of Drug Interactions Interval 0.0 to 2.0	NA Number of Drug Interactions For the Continued ART Regimen Group, drug drug interactions were not assessed at week 24.
Number of Drug Drug Interactions Week 48	1 Number of Drug Interactions Interval 0.0 to 2.0	0 Number of Drug Interactions Interval 0.0 to 1.0
Number of Drug Drug Interactions Week 96	1 Number of Drug Interactions Interval 0.0 to 2.0	0 Number of Drug Interactions Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Fasting lipids level evaluation - triglycerides

Outcome measures

Measure	DTG/RPV FDC Regimen n=93 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Fasting Lipids From Baseline - Triglycerides Change from baseline to week 96	-0.12 mmol/L Standard Error 0.18	-0.18 mmol/L Standard Error 0.27
Changes in Fasting Lipids From Baseline - Triglycerides Change from baseline to week 48	-0.26 mmol/L Standard Error 0.15	-0.02 mmol/L Standard Error 0.22
Changes in Fasting Lipids From Baseline - Triglycerides Change from week 48 to week 96	0.14 mmol/L Standard Error 0.15	-0.16 mmol/L Standard Error 0.23

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Fasting lipids level evaluation - LDL

Outcome measures

Measure	DTG/RPV FDC Regimen n=93 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=42 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Fasting Lipids From Baseline - Low Density Lipoprotein (LDL) Change from baseline to week 48	-0.05 mmol/L Standard Error 0.12	0 mmol/L Standard Error 0.18
Changes in Fasting Lipids From Baseline - Low Density Lipoprotein (LDL) Change from week 48 to week 96	0.02 mmol/L Standard Error 0.12	-0.14 mmol/L Standard Error 0.19
Changes in Fasting Lipids From Baseline - Low Density Lipoprotein (LDL) Change from baseline to week 96	-0.02 mmol/L Standard Error 0.15	-0.14 mmol/L Standard Error 0.23

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Changes in Vital Signs from baseline - Systolic Blood Pressure

Outcome measures

Measure	DTG/RPV FDC Regimen n=93 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Vital Signs From Baseline - Systolic Blood Pressure Change from baseline to week 48	-1.4 mmHg Standard Error 2.2	4.9 mmHg Standard Error 3.3
Changes in Vital Signs From Baseline - Systolic Blood Pressure Change from week 48 to week 96	-0.1 mmHg Standard Error 2.3	5.6 mmHg Standard Error 3.6
Changes in Vital Signs From Baseline - Systolic Blood Pressure Change from baseline to week 96	-1.5 mmHg Standard Error 2.7	10.5 mmHg Standard Error 4.1

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Changes in Vital Signs from baseline - Diastolic Blood Pressure

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Vital Signs From Baseline - Diastolic Blood Pressure Change from baseline to week 48	0.2 mmHg Standard Error 1.5	3.1 mmHg Standard Error 2.2
Changes in Vital Signs From Baseline - Diastolic Blood Pressure Change from week 48 to week 96	-0.7 mmHg Standard Error 1.6	0.8 mmHg Standard Error 2.4
Changes in Vital Signs From Baseline - Diastolic Blood Pressure Change from baseline to week 96	-0.5 mmHg Standard Error 1.8	4.0 mmHg Standard Error 2.7

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Changes in Vital Signs from baseline - Pulse rate

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Vital Signs From Baseline - Pulse Rate Change from baseline to week 48	2.1 beats per minute Standard Error 1.6	2.7 beats per minute Standard Error 2.4
Changes in Vital Signs From Baseline - Pulse Rate Change from week 48 to week 96	-2.5 beats per minute Standard Error 1.8	-1.5 beats per minute Standard Error 2.6
Changes in Vital Signs From Baseline - Pulse Rate Change from baseline to week 96	-0.4 beats per minute Standard Error 2.0	1.2 beats per minute Standard Error 2.9

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

The PSQI measures several different aspects of sleep, with seven component scores and one composite score. The component scores include questions on subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.

Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance to sleep. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties

Outcome measures

Measure	DTG/RPV FDC Regimen n=88 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=40 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in Pittsburgh Sleep Quality Index (PSQI) Change from baseline to week 48	-0.1 Global PSQI score on a scale Standard Error 0.3	-0.7 Global PSQI score on a scale Standard Error 0.5
Changes in Pittsburgh Sleep Quality Index (PSQI) Change from week 48 to week 96	0 Global PSQI score on a scale Standard Error 0.3	-0.5 Global PSQI score on a scale Standard Error 0.5
Changes in Pittsburgh Sleep Quality Index (PSQI) Change from baseline to week 96	-0.1 Global PSQI score on a scale Standard Error 0.3	-1.2 Global PSQI score on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: From Week 48 to week 96

Adverse Events reports (AEs, SAEs and treatment discontinuation)

Outcome measures

Measure	DTG/RPV FDC Regimen n=87 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=40 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Number of Participants With Adverse Events - Week 48 to Week 96 Any Adverse Events (AEs)	54 Participants	28 Participants
Number of Participants With Adverse Events - Week 48 to Week 96 Grade 1	36 Participants	18 Participants
Number of Participants With Adverse Events - Week 48 to Week 96 Grade 2	20 Participants	12 Participants
Number of Participants With Adverse Events - Week 48 to Week 96 Grade 3-4	5 Participants	5 Participants
Number of Participants With Adverse Events - Week 48 to Week 96 Missing grade	7 Participants	0 Participants
Number of Participants With Adverse Events - Week 48 to Week 96 Drug related AEs	1 Participants	5 Participants
Number of Participants With Adverse Events - Week 48 to Week 96 Drug related grade 3-4 AEs	0 Participants	0 Participants
Number of Participants With Adverse Events - Week 48 to Week 96 AEs leading to study drug interruption	1 Participants	2 Participants
Number of Participants With Adverse Events - Week 48 to Week 96 SAEs	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Population: Change from baseline to week 48, Change from week 48 to week 96; Change from baseline to week 96 in participants in the DTG/RPV FDC Regimen and Continued ART Regimen arms

Outcome measures

Measure	DTG/RPV FDC Regimen n=94 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Change From Baseline in CD4 Change from baseline to week 48	-31.7 CD4 count cells/mm^3 Standard Error 34.8	9.2 CD4 count cells/mm^3 Standard Error 51
Change From Baseline in CD4 Change from week 48 to week 96	27.3 CD4 count cells/mm^3 Standard Error 36.3	-9.8 CD4 count cells/mm^3 Standard Error 55.3
Change From Baseline in CD4 Change from baseline to week 96	-4.4 CD4 count cells/mm^3 Standard Error 47.1	-0.7 CD4 count cells/mm^3 Standard Error 71.0

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Population: Change from baseline to week 48, Change from week 48 to week 96; Change from baseline to week 96 in participants in the DTG/RPV FDC Regimen and Continued ART Regimen arms

Change from baseline to week 48, Change from week 48 to week 96; Change from baseline to week 96 in participants in the DTG/RPV FDC Regimen and Continued ART Regimen arms

Outcome measures

Measure	DTG/RPV FDC Regimen n=94 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Change From Baseline in CD8 Cell Count Change from baseline to week 48	-58.8 CD8 cell count: cells/mm^3 Standard Error 41.3	9.7 CD8 cell count: cells/mm^3 Standard Error 60.4
Change From Baseline in CD8 Cell Count Change from week 48 to week 96	-5.7 CD8 cell count: cells/mm^3 Standard Error 43.2	-55.8 CD8 cell count: cells/mm^3 Standard Error 66.6
Change From Baseline in CD8 Cell Count Change from baseline to week 96	-64.5 CD8 cell count: cells/mm^3 Standard Error 53.4	-46.1 CD8 cell count: cells/mm^3 Standard Error 81.3

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Population: Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96 in subjects in DTG/RPV FDC Regimen and Continued ART Regimen arms

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Change From Baseline in Body Weight Change from baseline to week 96	2.4 Body weight, kg Standard Error 3.0	2.6 Body weight, kg Standard Error 4.5
Change From Baseline in Body Weight Change from baseline to week 48	0.7 Body weight, kg Standard Error 2.1	1.3 Body weight, kg Standard Error 3.1
Change From Baseline in Body Weight Change from week 48 to week 96	1.7 Body weight, kg Standard Error 2.2	1.3 Body weight, kg Standard Error 3.4

SECONDARY outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Population: Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96 in DTG/RPV FDC Regimen and Continued ART Regimen arms

Outcome measures

Measure	DTG/RPV FDC Regimen n=95 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Change From Baseline in BMI Change from baseline to week 48	0.3 kg/m^2 Standard Error 0.6	0.6 kg/m^2 Standard Error 0.9
Change From Baseline in BMI Change from week 48 to week 96	0.5 kg/m^2 Standard Error 0.7	0.3 kg/m^2 Standard Error 1.0
Change From Baseline in BMI Change from baseline to week 96	0.8 kg/m^2 Standard Error 0.9	0.9 kg/m^2 Standard Error 1.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

High Sensitivity C-Reactive Protein evaluation

Outcome measures

Measure	DTG/RPV FDC Regimen n=52 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=24 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in High Sensitivity C-Reactive Protein Change from baseline to week 48	0.8 mg/L Standard Error 1.2	-1.3 mg/L Standard Error 1.8
Changes in High Sensitivity C-Reactive Protein Change from week 48 to week 96	0.5 mg/L Standard Error 1.2	-0.9 mg/L Standard Error 1.9
Changes in High Sensitivity C-Reactive Protein Change from baseline to week 96	1.3 mg/L Standard Error 1.4	-2.2 mg/L Standard Error 2.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

CD4/CD8 evaluation

Outcome measures

Measure	DTG/RPV FDC Regimen n=94 Participants One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 Participants Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Changes in CD4/CD8 Ratio Change from Baseline to week 48	0.03 ratio Standard Error 0.06	0.02 ratio Standard Error 0.09
Changes in CD4/CD8 Ratio Change from week 48 to week 96	0.04 ratio Standard Error 0.06	0 ratio Standard Error 0.1
Changes in CD4/CD8 Ratio Change from Baseline to week 96	0.07 ratio Standard Error 0.08	0.01 ratio Standard Error 0.13

Adverse Events

DTG/RPV FDC Regimen

Serious events: 12 serious events

Other events: 66 other events

Deaths: 0 deaths

Continued ART Regimen

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	DTG/RPV FDC Regimen n=95 participants at risk One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 participants at risk Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	1.1% 1/95 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations pachymeningitis	1.1% 1/95 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Injury, poisoning and procedural complications Toxicity to various agents	1.1% 1/95 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Psychiatric disorders Suicidal ideation	1.1% 1/95 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Surgical and medical procedures Prostatectomy	1.1% 1/95 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.1% 1/95 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	1.1% 1/95 • Number of events 2 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile neoplasm	0.00% 0/95 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	2.2% 1/45 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations Pilonidal cyst	1.1% 1/95 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Gastrointestinal disorders pancreatitis	0.00% 0/95 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	2.2% 1/45 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Injury, poisoning and procedural complications Patella fracture	1.1% 1/95 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations Pneumonia bacterial	1.1% 1/95 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations COVID-19 pneumonia	0.00% 0/95 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	2.2% 1/45 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations Legionella infection	1.1% 1/95 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations Atypical mycobacterial infection	0.00% 0/95 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	2.2% 1/45 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations Postoperative wound infection	1.1% 1/95 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.

Other adverse events

Measure	DTG/RPV FDC Regimen n=95 participants at risk One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet	Continued ART Regimen n=45 participants at risk Patients will continue the current boosted PI regimen (or other antiretroviral combination) for 48 weeks. Patients will then be switched to one combined Dolutegravir/Rilpivirine FDC tablet taken orally once daily for 48 weeks. Dolutegravir \& Rilpivirine 2 drug fixed dose combined therapy: Daily oral tablet
Nervous system disorders headache	16.8% 16/95 • Number of events 21 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	4.4% 2/45 • Number of events 2 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Psychiatric disorders Insomnia	8.4% 8/95 • Number of events 8 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	2.2% 1/45 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Gastrointestinal disorders Constipation	6.3% 6/95 • Number of events 7 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Gastrointestinal disorders Diarrhoea	6.3% 6/95 • Number of events 6 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	8.9% 4/45 • Number of events 4 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations COVID-19	9.5% 9/95 • Number of events 9 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	6.7% 3/45 • Number of events 3 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
General disorders Pyrexia	5.3% 5/95 • Number of events 5 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Metabolism and nutrition disorders Vitamin D deficiency	6.3% 6/95 • Number of events 6 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Investigations Alanine aminotransferase increased	8.4% 8/95 • Number of events 8 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 5/95 • Number of events 5 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	4.4% 2/45 • Number of events 2 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations Urinary tract infection	6.3% 6/95 • Number of events 7 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	4.4% 2/45 • Number of events 3 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations Syphilis	6.3% 6/95 • Number of events 8 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	4.4% 2/45 • Number of events 2 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations Rhinitis	5.3% 5/95 • Number of events 5 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	2.2% 1/45 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Skin and subcutaneous tissue disorders Rash	5.3% 5/95 • Number of events 12 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 3/95 • Number of events 3 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	6.7% 3/45 • Number of events 3 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Infections and infestations Nasopharyngitis	6.3% 6/95 • Number of events 8 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	11.1% 5/45 • Number of events 7 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 5/95 • Number of events 5 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	2.2% 1/45 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Vascular disorders Hypertension	6.3% 6/95 • Number of events 6 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	2.2% 1/45 • Number of events 1 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.
Investigations Blood creatinine increased	5.3% 5/95 • Number of events 5 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.	0.00% 0/45 • Adverse events were collected from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). This is on average from the baseline visit (+/- 30 days) until week 96 (+/- 30 days) . The adverse event reporting period will be from consent until the subject's final study visit (I.e. follow-up visit or end of trial visit). In addition, any untoward event that may occur subsequent to the reporting period that the Investigator assesses as possibly, probably or definitely related to the study drug medication should also be reported as an Adverse Event.

Additional Information

Clinical Project Manager

Research Organisation (KC) Ltd

Phone: 07376618244

Email: WISARD@rokcservices.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place