Open-Label Multi-Centre Randomised Switch Study to Evalua... | NCT05349838

NCT05349838

ID	Type	Description	Link
2017-004040-38	EudraCT Number

Status Module

Sponsor/Collaborators Module

Name	Class
ViiV Healthcare	INDUSTRY

Oversight Module

Description Module

Brief Summary

HIV-1 infected subjects that experience virological failure while on non nucleoside reverse-transcriptase inhibitors (NNRTIs), including those with the K103N mutation, are usually switched to a boosted Protease Inhibitor (PI)-based regimen or other antiretroviral (ARV) combinations. The same is true for subjects who need to start antiretroviral therapy and have acquired virus that is already resistant to antiretrovirals. These "second line" combinations are often associated with numerous issues that can have a potential impact on the quality of life (QoL) of these patients. Therefore a simpler and better tolerated alternative second line treatment option would be a useful tool for the clinical management of these patients.

The aim of this study is to assess the efficacy and tolerability of a dual combined therapy of Dolutegravir (DTG) 50 mg Once Daily (OD) + Rilpivirine (RPV) 25 mg OD in virologically suppressed participants with previous virological failure with NNRTIs and having the clinically significant mutation K103N. The secondary objective of the study is to assess whether a simplification of the treatment in terms of pill burden, long term metabolic toxicity and potential for drug interactions improves the QOL of the participants. The study will also evaluate DTG & RPV concentrations in the blood plus changes in cell associated virus.

In order to compare the first line treatment (boosted PI and/or other antiretroviral combinations) and the DTG+RPV combination, two thirds of study participants will be switched to DTG+RPV immediately and receive DTG+RPV for 96 weeks. The other third will be switched after 48 weeks of continuing on their first line treatment and receive DTG+RPV for 48 weeks. All participants will then be followed up for a further 30 days. Participants will be recruited from sites across Europe, and randomised onto either arm of the study. After randomisation, participants will attend approximately 10 visits over the course of two years.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DTG/RPV FDC Regimen	Experimental	One combined Dolutegravir 50mg /Rilpivirine 25mg FDC tablet taken orally once daily	Drug: Dolutegravir & Rilpivirine 2 drug fixed dose combined therapy
Continued ART Regimen	Active Comparator	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.	Drug: Dolutegravir & Rilpivirine 2 drug fixed dose combined therapy

Name	Type	Description	Arm Group Labels	Other Names
Dolutegravir & Rilpivirine 2 drug fixed dose combined therapy	Drug	Daily oral tablet	Continued ART Regimen DTG/RPV FDC Regimen

Outcomes Module

Measure	Description	Time Frame
Number of Participants With and Without Virological Suppression	Virological Suppression is defined as <50 copies/ml HIV RNA	48 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With and Without Virological Suppression	Virological Suppression is defined as <50 copies/ml HIV RNA	week 96
Changes in Blood Cell Counts - Red Blood Cells	red blood cell count evaluation

Other Outcomes

Measure	Description	Time Frame
Changes in High Sensitivity C-Reactive Protein	High Sensitivity C-Reactive Protein evaluation	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96
Changes in CD4/CD8 Ratio

Eligibility Module

Eligibility Criteria

Inclusion criteria

Patient volunteers who meet all of the following criteria are eligible for this trial:

Is male or female aged 18 years or over.
Has documented HIV-1 infection
Is capable of giving informed consent
Is willing to comply with the protocol requirements
Virologically suppressed (plasma HIV-RNA <50 copies/mL for >24 weeks) and on a stable regimen.
Subjects are required to have a history of the K103N mutation (acquired or selected). Subjects who at any time have had the mutations 100I, 101E/P, 106A/M, 138K/G/Q, 181C/I/V, 188L, 190A/S/E/Q, 230L mutations are to be excluded. Other NNRTI region variants can be included. All PI and NRTI mutations are acceptable. Study sites may ask the coordinating centre for advice as required.
Subjects must have never failed INSTI (2 x VL >200 >2 weeks apart) but current regimen can include Integrase Strand Transfer Inhibitor(INSTI).
A female, may be eligible to enter and participate in the study if she:

a. is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea without an alternative medical cause and ≥ 45 years of age) A high follicle stimulating hormone (FSH) level consistent with postmenopausal status may be used to confirm a post- menopausal state in women who are not using hormonal contraception) or hormonal replacement therapy at the discretion of the Principal Investigator. However, in the absence of 12 months of amenorrhea, a single FSH measurement alone is insufficient.

OR physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,

OR is of child-bearing potential with a negative pregnancy test at Screening (& baseline visit) and agrees to use one of the following methods of contraception to avoid pregnancy:

True abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications (When this is in line with the preferred and usual lifestyle of the subject.) (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), and withdrawal are not acceptable methods of contraception.

Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see Appendix 3 for an example listing of approved IUDs).

Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject;

Approved hormonal contraception (see appendix 4 for a listing of examples of approved hormonal contraception);

Any other method with published data showing that the expected failure rate is <1% per year.

Any contraceptive method must be used consistently and for at least 2 weeks after discontinuation of Investigational Product (IP)
If a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit
Subjects currently receiving DTG or RPV, but not both, can be included.

Exclusion criteria

Patients meeting 1 or more of the following criteria cannot be selected:

Infected with HIV-2
Detectable HIV-1 RNA at screening (HIV-1 RNA measurement >=50 c/mL).
Subjects requiring regular dosing doing with H2 or PPI antacid medications or a history of achlorhidria or drug known to interact with RPV or DTG.
Use of medications which are associated with Torsades de Pointes
Corrected QT interval (QTc [Bazett]) >450 milliseconds or QTc (Bazett) >480 milliseconds for participants with bundle branch block. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB).
Unstable health conditions (i.e. opportunistic infections, cancers, unstable liver disease etc).
Any evidence of an active Centers for Disease Control and Prevention Category C disease. Exceptions include cutaneous Kaposi's sarcoma not requiring systemic therapy and historic CD4+ lymphocyte counts of <200 cells/millimeter3.
History or presence of allergy to the study drugs or their components or drugs of their class;
Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to randomization;
Any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the subject's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participants. Subjects considered to pose a significant risk of suicide should be excluded.
Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the subject unable to take oral medication;
Using any concomitant therapy disallowed as per the reference safety information and product labelling for the study drugs. Specifically, co-administration with the following medicinal products is not allowed:
- dofetilide or pilsicainide;
- fampridine (also known as dalfampridine);
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin;
- rifampicin, rifapentine;
- proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole; - systemic dexamethasone, except as a single dose treatment;
- St John's wort (Hypericum perforatum).
Has acute viral hepatitis including, but not limited to, A, B, or C
Active hepatitis B/ Hep B non-immune subjects who have failed vaccination (antibody concentration < 10 international units). (If local practice does not include vaccination of low risk patients, then the patients without HBsAb are not excluded - this must be clearly documented in the medical records and eCRF). (Note: subjects can be re screened if they receive vaccination and subsequently meet eligibility criteria)
Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), and Hepatitis B surface antibody (HBsAb) as follows: Participants positive for HBsAg are excluded; Participants positive for anti-HBc (negative HBsAg status) and negative for HBsAb are excluded. (if local practice does not include vaccination of low risk patients, then the patients without HBsAb are not excluded - this must be clearly documented in the medical records and eCRF. Note: Subject positive for anti-HBc (negative HBsAg status) and positive for HBsAb are immune to HBV and are not excluded.
Participants with an anticipated need for any Hepatitis C virus (HCV) therapy during the Early Switch Phase and for interferon-based therapy for HCV throughout the entire study period.
Any investigational drug within 30 days prior to the trial drug administration
Any evidence of viral resistance different to the one described in the inclusion criteria i.e. not meeting inclusion criteria or having different mutation at K103.
Dialysis or renal insufficiency (creatinine clearance < 50ml/min)
History of decompensated liver disease (Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal (ULN), OR ALT ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin)
Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification (see appendix 4)
Opportunistic infection within 4 weeks prior to first dose of DTG plus RPV.
Clinical decision that a switch of antiretroviral therapy should be immediate
Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed). or unconjugated hyperbilirubinaemia due to atanazavir exposure.
Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.
Women planning pregnancy or who are pregnant or breast feeding. (NB: See section 6.12 Withdrawal Criteria for guidance if pregnancy does occur).
Females of childbearing potential and males must be willing to use a highly effective (acceptable effective contraceptive measures are only acceptable for IMP's with unlikely human teratogenicity / fetotoxicity in early pregnancy) method of contraception (hormonal method of birth control; true abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods (see Appendix 4). Such methods include:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral intravaginal transdermal
- progesteron-only hormonal contraception associated with inhibition of ovulation oral injectable implantable
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system ( IUS)
- bilateral tubal occlusion
- vasectomized partner
- true sexual abstinence
(NB: See section 6.12 Withdrawal Criteria for guidance if pregnancy does occur).
Hypersensitivity to the active substances or to any of the excipients listed below: List of excipients Tablet core • Mannitol (E421) • Magnesium stearate • Microcrystalline cellulose • Povidone (K29/32) • Sodium starch glycolate • Sodium stearyl fumarate • Lactose monohydrate • Croscarmellose sodium • Povidone (K30) • Polysorbate 20 • Silicified microcrystalline cellulose Tablet coating • Polyvinyl alcohol- part hydrolysed • Titanium dioxide (E171) • Macrogol • Talc • Iron oxide yellow (E172) Iron oxide red (E172)

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Tropical Medecine		Antwerp			Belgium
St Pierre University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41587441	Derived	Moyle G, Assoumou L, De Castro N, Post FA, Curran A, Rusconi S, De Wit S, Stephan C, Raffi F, Johnson M, Masia M, Vera J, Jones B, Fletcher C, Morris K, Pozniak A; for NEAT Foundation, WISARD study group. Durable efficacy of dolutegravir/rilpivirine switch in subjects with HIV RNA <50 copies/ml and history of K103N mutation. AIDS. 2026 Jul 1;40(7):885-893. doi: 10.1097/QAD.0000000000004451. Epub 2026 Jan 22.
38417976

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	Continued ART Regimen

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 30, 2020	Oct 23, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Boosted protease inhibitors or other ARV 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

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Inter-Quartile Range

years

Title

Denominators

Categories

HIV RNA < 50 copies/mL

Title	Measurements
	OG00084 OG00140

HIV RNA >= 50 copies/mL

Title	Measurements
	OG000

Secondary

Number of Participants With and Without Virological Suppression

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

Posted

Count of Participants

Participants

week 96

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Blood Cell Counts - Red Blood Cells

red blood cell count evaluation

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

Posted

Mean

Standard Error

Red Blood Cells 10^12/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Changes in Blood Cell Counts - White Blood Cells

white blood cell count evaluation

Posted

Mean

Standard Error

White Blood Cells 10^12/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Blood Cell Counts - Platelets

platelet count evaluation

Posted

Mean

Standard Error

Platelets 10^9/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Blood Cell Counts - Haemoglobin

Haemoglobin count evaluation

Posted

Mean

Standard Error

g/dL

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Sodium

Change from baseline in Sodium

Posted

Mean

Standard Error

mmol/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Liver Levels - Bilirubin

Liver level evaluation - bilirubin

Posted

Mean

Standard Error

umol/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Liver Levels - Alanine Aminotransferase (ALT)

Liver level evaluation - ALT

Posted

Mean

Standard Error

U/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Renal Markers - Creatinine Clearance (Estimated Glomerular Filtration Rate(eGFR))

Renal markers evaluation- creatinine clearance (eGFR)

Posted

Mean

Standard Error

eGFR mL/min

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Glucose

Change from baseline in Glucose

Posted

Mean

Standard Error

mmol/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Renal Markers - Creatinine

Renal markers evaluation - creatinine

Posted

Mean

Standard Error

umol/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Bone Markers - Alkaline Phosphatase

Bone markers evaluation - Alkaline phosphatase

Posted

Mean

Standard Error

U/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Fasting Lipids From Baseline - Total Cholesterol

Fasting lipids level evaluation - total cholesterol

Posted

Mean

Standard Error

mmol/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Fasting Lipids From Baseline - High Density Lipoprotein (HDL)

Fasting lipids level evaluation - HDL

Posted

Mean

Standard Error

mmol/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Quality of Life Health Status Score

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.

Posted

Mean

Standard Error

score on a scale

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Secondary

Changes in Patient Satisfaction - HIV Treatment Satisfaction Questionnaire (HIVTSQs)

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.

Posted

Mean

Standard Error

Global satisfaction score

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants With Adverse Events - Baseline to Week 48

Adverse Events reports (AEs, SAEs and treatment discontinuation)

Posted

Count of Participants

Participants

Baseline to week 48

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Drug Drug Interactions

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)

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

Posted

Median

Inter-Quartile Range

Number of Drug Interactions

Baseline, week 24, week 48, week 96

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Changes in Fasting Lipids From Baseline - Triglycerides

Fasting lipids level evaluation - triglycerides

Posted

Mean

Standard Error

mmol/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Fasting Lipids From Baseline - Low Density Lipoprotein (LDL)

Fasting lipids level evaluation - LDL

Posted

Mean

Standard Error

mmol/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Vital Signs From Baseline - Systolic Blood Pressure

Changes in Vital Signs from baseline - Systolic Blood Pressure

Posted

Mean

Standard Error

mmHg

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Vital Signs From Baseline - Diastolic Blood Pressure

Changes in Vital Signs from baseline - Diastolic Blood Pressure

Posted

Mean

Standard Error

mmHg

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Vital Signs From Baseline - Pulse Rate

Changes in Vital Signs from baseline - Pulse rate

Posted

Mean

Standard Error

beats per minute

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Changes in Pittsburgh Sleep Quality Index (PSQI)

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

Posted

Mean

Standard Error

Global PSQI score on a scale

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Participants With Adverse Events - Week 48 to Week 96

Adverse Events reports (AEs, SAEs and treatment discontinuation)

Posted

Count of Participants

Participants

From Week 48 to week 96

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4

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

Posted

Mean

Standard Error

CD4 count cells/mm^3

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD8 Cell Count

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

Posted

Mean

Standard Error

CD8 cell count: cells/mm^3

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Secondary

Change From Baseline in Body Weight

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

Posted

Mean

Standard Error

Body weight, kg

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Change From Baseline in BMI

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

Posted

Mean

Standard Error

kg/m^2

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Other Pre-specified

Changes in High Sensitivity C-Reactive Protein

High Sensitivity C-Reactive Protein evaluation

Posted

Mean

Standard Error

mg/L

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Other Pre-specified

Changes in CD4/CD8 Ratio

CD4/CD8 evaluation

Posted

Mean

Standard Error

ratio

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	95	12	95	66	95
EG001	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	0	45	4	45	19	45

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected95 at risk EG0010 events0 affected45 at risk
pachymeningitis	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected95 at risk EG0010 events0 affected45 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected95 at risk EG0010 events0 affected45 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected95 at risk EG0010 events0 affected45 at risk
Prostatectomy	Surgical and medical procedures	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected95 at risk EG0010 events0 affected45 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected95 at risk EG0010 events0 affected45 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.0)	Systematic Assessment	EG0002 events1 affected95 at risk EG0010 events0 affected45 at risk
Penile neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected95 at risk EG0011 events1 affected45 at risk
Pilonidal cyst	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected95 at risk EG0010 events0 affected45 at risk
pancreatitis	Gastrointestinal disorders	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected95 at risk EG0011 events1 affected45 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected95 at risk EG0010 events0 affected45 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected95 at risk EG0010 events0 affected45 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected95 at risk EG0011 events1 affected45 at risk
Legionella infection	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected95 at risk EG0010 events0 affected45 at risk
Atypical mycobacterial infection	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0000 events0 affected95 at risk EG0011 events1 affected45 at risk
Postoperative wound infection	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0001 events1 affected95 at risk EG0010 events0 affected45 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
headache	Nervous system disorders	MedDRA (24.0)	Systematic Assessment	EG00021 events16 affected95 at risk EG0012 events2 affected45 at risk
Insomnia	Psychiatric disorders	MedDRA (23.0)	Systematic Assessment	EG0008 events8 affected95 at risk EG0011 events1 affected45 at risk
Constipation	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0007 events6 affected95 at risk EG0010 events0 affected45 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (24.0)	Systematic Assessment	EG0006 events6 affected95 at risk EG0014 events4 affected45 at risk
COVID-19	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0009 events9 affected95 at risk EG0013 events3 affected45 at risk
Pyrexia	General disorders	MedDRA (23.0)	Systematic Assessment	EG0005 events5 affected95 at risk EG0010 events0 affected45 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (23.0)	Systematic Assessment	EG0006 events6 affected95 at risk EG0010 events0 affected45 at risk
Alanine aminotransferase increased	Investigations	MedDRA (24.0)	Systematic Assessment	EG0008 events8 affected95 at risk EG0010 events0 affected45 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0005 events5 affected95 at risk EG0012 events2 affected45 at risk
Urinary tract infection	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0007 events6 affected95 at risk EG0013 events2 affected45 at risk
Syphilis	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0008 events6 affected95 at risk EG0012 events2 affected45 at risk
Rhinitis	Infections and infestations	MedDRA (23.0)	Systematic Assessment	EG0005 events5 affected95 at risk EG0011 events1 affected45 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (23.0)	Systematic Assessment	EG00012 events5 affected95 at risk EG0010 events0 affected45 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (23.0)	Systematic Assessment	EG0003 events3 affected95 at risk EG0013 events3 affected45 at risk
Nasopharyngitis	Infections and infestations	MedDRA (24.0)	Systematic Assessment	EG0008 events6 affected95 at risk EG0017 events5 affected45 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (24.0)	Systematic Assessment	EG0005 events5 affected95 at risk EG0011 events1 affected45 at risk
Hypertension	Vascular disorders	MedDRA (24.0)	Systematic Assessment	EG0006 events6 affected95 at risk EG0011 events1 affected45 at risk
Blood creatinine increased	Investigations	MedDRA (24.0)	Systematic Assessment	EG0005 events5 affected95 at risk EG0010 events0 affected45 at risk

ID	Term
C562325	dolutegravir
D011616	Psychotherapy, Multiple

For the Continued ART Regimen Group, drug drug interactions were not assessed at week 24.

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities