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

An Open-Label, Multi-Centre, Randomised, Switch Study to Evaluate the Virological Efficacy Over 96 Weeks Of 2-Drug Therapy With DTG/RPV FDC in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Resistance Mutation K103N

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05349838

Acronym

WISARD

Enrollment

140

Registered

2022-04-27

Start date

2018-11-05

Completion date

2022-11-09

Last updated

2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1-infection

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.

Interventions

DRUGDolutegravir & Rilpivirine 2 drug fixed dose combined therapy

Daily oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patient volunteers who meet all of the following criteria are eligible for this trial: 1. Is male or female aged 18 years or over. 2. Has documented HIV-1 infection 3. Is capable of giving informed consent 4. Is willing to comply with the protocol requirements 5. Virologically suppressed (plasma HIV-RNA \<50 copies/mL for \>24 weeks) and on a stable regimen. 6. 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. 7. Subjects must have never failed INSTI (2 x VL \>200 \>2 weeks apart) but current regimen can include Integrase Strand Transfer Inhibitor(INSTI). 8. 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) 9. 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 10. 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: 1. Infected with HIV-2 2. Detectable HIV-1 RNA at screening (HIV-1 RNA measurement \>=50 c/mL). 3. 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. 4. Use of medications which are associated with Torsades de Pointes 5. 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). 6. Unstable health conditions (i.e. opportunistic infections, cancers, unstable liver disease etc). 7. 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. 8. History or presence of allergy to the study drugs or their components or drugs of their class; 9. 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; 10. 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. 11. 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; 12. 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). 13. Has acute viral hepatitis including, but not limited to, A, B, or C 14. 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) 15. 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. 16. 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. 17. Any investigational drug within 30 days prior to the trial drug administration 18. 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. 19. Dialysis or renal insufficiency (creatinine clearance \< 50ml/min) 20. 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) 21. 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) 22. Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification (see appendix 4) 23. Opportunistic infection within 4 weeks prior to first dose of DTG plus RPV. 24. Clinical decision that a switch of antiretroviral therapy should be immediate 25. 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. 26. 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. 27. Women planning pregnancy or who are pregnant or breast feeding. (NB: See section 6.12 Withdrawal Criteria for guidance if pregnancy does occur). 28. 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). 29. 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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of Participants With and Without Virological Suppression	week 96	Virological Suppression is defined as \<50 copies/ml HIV RNA
Changes in Blood Cell Counts - Red Blood Cells	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	red blood cell count evaluation
Changes in Blood Cell Counts - White Blood Cells	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	white blood cell count evaluation
Changes in Blood Cell Counts - Platelets	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	platelet count evaluation
Changes in Blood Cell Counts - Haemoglobin	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Haemoglobin count evaluation
Change From Baseline in Sodium	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Change from baseline in Sodium
Changes in Liver Levels - Bilirubin	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Liver level evaluation - bilirubin
Changes in Liver Levels - Alanine Aminotransferase (ALT)	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Liver level evaluation - ALT
Changes in Renal Markers - Creatinine Clearance (Estimated Glomerular Filtration Rate(eGFR))	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Renal markers evaluation- creatinine clearance (eGFR)
Change From Baseline in Glucose	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Change from baseline in Glucose
Changes in Renal Markers - Creatinine	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Renal markers evaluation - creatinine
Changes in Bone Markers - Alkaline Phosphatase	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Bone markers evaluation - Alkaline phosphatase
Changes in Fasting Lipids From Baseline - Total Cholesterol	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Fasting lipids level evaluation - total cholesterol
Changes in Fasting Lipids From Baseline - High Density Lipoprotein (HDL)	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Fasting lipids level evaluation - HDL
Changes in Quality of Life Health Status Score	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.
Change From Baseline in Body Weight	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	—
Change From Baseline in BMI	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	—
Changes in Patient Satisfaction - HIV Treatment Satisfaction Questionnaire (HIVTSQs)	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.
Number of Participants With Adverse Events - Baseline to Week 48	Baseline to week 48	Adverse Events reports (AEs, SAEs and treatment discontinuation)
Number of Drug Drug Interactions	Baseline, week 24, week 48, week 96	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)
Changes in Fasting Lipids From Baseline - Triglycerides	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Fasting lipids level evaluation - triglycerides
Changes in Fasting Lipids From Baseline - Low Density Lipoprotein (LDL)	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Fasting lipids level evaluation - LDL
Changes in Vital Signs From Baseline - Systolic Blood Pressure	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
Changes in Vital Signs From Baseline - Diastolic Blood Pressure	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
Changes in Vital Signs From Baseline - Pulse Rate	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	Changes in Vital Signs from baseline - Pulse rate
Changes in Pittsburgh Sleep Quality Index (PSQI)	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
Number of Participants With Adverse Events - Week 48 to Week 96	From Week 48 to week 96	Adverse Events reports (AEs, SAEs and treatment discontinuation)
Change From Baseline in CD4	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	—
Change From Baseline in CD8 Cell Count	Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96	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

Other

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

Countries

Belgium, France, Germany, Italy, Spain, United Kingdom

Participant flow

Recruitment details

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.

Pre-assignment details

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

Participants by arm

Arm	Count
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	95
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	45
Total	140

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	3	1
Overall Study	Lost to Follow-up	1	2
Overall Study	Other reasons	5	1
Overall Study	Virological Failure	1	2
Overall Study	Withdrawal by Subject	2	3

Baseline characteristics

Characteristic	DTG/RPV FDC Regimen	Continued ART Regimen	Total
Age, Continuous	52 years	53 years	52 years
ART at enrolment Abcavir/Lamivudine	17 Participants	8 Participants	25 Participants
ART at enrolment Amprenavir	1 Participants	0 Participants	1 Participants
ART at enrolment Atazanavir	8 Participants	5 Participants	13 Participants
ART at enrolment Bictegravir	3 Participants	1 Participants	4 Participants
ART at enrolment Darunavir	50 Participants	22 Participants	72 Participants
ART at enrolment Dolutegravir	20 Participants	8 Participants	28 Participants
ART at enrolment Elvitegravir	7 Participants	5 Participants	12 Participants
ART at enrolment Etravirine	6 Participants	4 Participants	10 Participants
ART at enrolment Integrase Strand Transfer Inhibitor (INSTI) regimen	46 Participants	21 Participants	67 Participants
ART at enrolment Lopinavir	1 Participants	0 Participants	1 Participants
ART at enrolment Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) regimen	7 Participants	6 Participants	13 Participants
ART at enrolment Nucleoside Reverse Transcriptase Inhibitor (NRTI) regimen	72 Participants	36 Participants	108 Participants
ART at enrolment Other	8 Participants	5 Participants	13 Participants
ART at enrolment PI regimen	60 Participants	27 Participants	87 Participants
ART at enrolment Raltegravir	16 Participants	7 Participants	23 Participants
ART at enrolment Rilpivirine	1 Participants	2 Participants	3 Participants
ART at enrolment Tenofovir-AF (TDF) / Emtrictabine	22 Participants	15 Participants	37 Participants
ART at enrolment Tenofovir-DF (TDF) / Emtrictabine	25 Participants	7 Participants	32 Participants
Body Mass Index (BMI) (kg/m^2)	24.3 kg/m^2	26.4 kg/m^2	25.1 kg/m^2
Cd4 Cd8 % CD4+	33 % above versus below 350 cells/μL	31 % above versus below 350 cells/μL	32 % above versus below 350 cells/μL
Cd4 Cd8 % CD8+	39 % above versus below 350 cells/μL	39 % above versus below 350 cells/μL	39 % above versus below 350 cells/μL
CD4 CD8 cell count per uL CD4+ count	629 cells/uL	660 cells/uL	650 cells/uL
CD4 CD8 cell count per uL CD8+ count	720 cells/uL	790 cells/uL	753 cells/uL
Current smoker	34 Participants	12 Participants	46 Participants
Diabetes	6 Participants	4 Participants	10 Participants
Drinks alchohol	52 Participants	25 Participants	77 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Glu138Ala/Gly/Lys/Gln/Arg	0 Participants	0 Participants	0 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Gly190Ala/Ser/Glu	0 Participants	0 Participants	0 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations His221Tyr	3 Participants	0 Participants	3 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Leu100Ile	0 Participants	0 Participants	0 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Lys101Glu/Pro	0 Participants	0 Participants	0 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Met230Ile/Leu	0 Participants	0 Participants	0 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Phe227Cys/Leu/Arg	1 Participants	0 Participants	1 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Pro225His	7 Participants	1 Participants	8 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Tyr181Cys/Ile/Val	0 Participants	0 Participants	0 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Tyr188Cys/His/Leu	0 Participants	0 Participants	0 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Val106Ala/Ile/Met/Thr	1 Participants	3 Participants	4 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Val108Ile	7 Participants	4 Participants	11 Participants
Frequency of other Nucleoside Non-nucleoside reverse transcriptase inhibitors resistance mutations Val179Asp/Phe/Thr/Leu	2 Participants	1 Participants	3 Participants
Hepatitis B core antibodies	28 Participants	17 Participants	45 Participants
Hepatitis B surface antibodies	80 Participants	36 Participants	116 Participants
Hepatitis C IgG antibodies	9 Participants	3 Participants	12 Participants
History of HIV-1 resistance mutations Total number of drug resistance mutations according to IAS 2019	3 Number of mutations	4 Number of mutations	3 Number of mutations
History of HIV-1 resistance mutations Total number of NNRTI drug resistance mutations according to IAS 2019	1 Number of mutations	1 Number of mutations	1 Number of mutations
History of HIV-1 resistance mutations Total number of NRTI drug resistance mutations according to IAS 2019	1 Number of mutations	1 Number of mutations	1 Number of mutations
History of HIV-1 resistance mutations Total number of PI drug resistance mutations according to IAS 2019	0 Number of mutations	1 Number of mutations	1 Number of mutations
HIV Information Years on ART	16 years	17.7 years	16.5 years
HIV Information Years since HIV diagnosis	17.1 years	22.4 years	19.7 years
Hypertension	14 Participants	8 Participants	22 Participants
Race/Ethnicity, Customized Ethnicity N(%) African	3 Participants	3 Participants	6 Participants
Race/Ethnicity, Customized Ethnicity N(%) Asian	4 Participants	0 Participants	4 Participants
Race/Ethnicity, Customized Ethnicity N(%) Black	7 Participants	7 Participants	14 Participants
Race/Ethnicity, Customized Ethnicity N(%) Caribbean	1 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized Ethnicity N(%) Other	9 Participants	4 Participants	13 Participants
Race/Ethnicity, Customized Ethnicity N(%) White caucasian	69 Participants	29 Participants	98 Participants
Race/Ethnicity, Customized Ethnicity N(%) White mixed	2 Participants	1 Participants	3 Participants
Region of Enrollment Belgium	6 participants	3 participants	9 participants
Region of Enrollment France	23 participants	13 participants	36 participants
Region of Enrollment Germany	8 participants	2 participants	10 participants
Region of Enrollment Ireland	0 participants	1 participants	1 participants
Region of Enrollment Italy	7 participants	3 participants	10 participants
Region of Enrollment Spain	15 participants	7 participants	22 participants
Region of Enrollment United Kingdom	36 participants	16 participants	52 participants
Sex: Female, Male Female	16 Participants	10 Participants	26 Participants
Sex: Female, Male Male	79 Participants	35 Participants	114 Participants
Uses recreational drugs	15 Participants	7 Participants	22 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 95	0 / 45
other Total, other adverse events	66 / 95	19 / 45
serious Total, serious adverse events	12 / 95	4 / 45

Outcome results

Primary

Number of Participants With and Without Virological Suppression

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

Time frame: 48 weeks

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG/RPV FDC Regimen	Number of Participants With and Without Virological Suppression	HIV RNA < 50 copies/mL	84 Participants
DTG/RPV FDC Regimen	Number of Participants With and Without Virological Suppression	HIV RNA >= 50 copies/mL	3 Participants
DTG/RPV FDC Regimen	Number of Participants With and Without Virological Suppression	No virologic data at week 48	8 Participants
Continued ART Regimen	Number of Participants With and Without Virological Suppression	HIV RNA < 50 copies/mL	40 Participants
Continued ART Regimen	Number of Participants With and Without Virological Suppression	HIV RNA >= 50 copies/mL	1 Participants
Continued ART Regimen	Number of Participants With and Without Virological Suppression	No virologic data at week 48	4 Participants

Secondary

Change From Baseline in BMI

Time frame: 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

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Change From Baseline in BMI	Change from baseline to week 48	0.3 kg/m^2	Standard Error 0.6
DTG/RPV FDC Regimen	Change From Baseline in BMI	Change from week 48 to week 96	0.5 kg/m^2	Standard Error 0.7
DTG/RPV FDC Regimen	Change From Baseline in BMI	Change from baseline to week 96	0.8 kg/m^2	Standard Error 0.9
Continued ART Regimen	Change From Baseline in BMI	Change from baseline to week 48	0.6 kg/m^2	Standard Error 0.9
Continued ART Regimen	Change From Baseline in BMI	Change from week 48 to week 96	0.3 kg/m^2	Standard Error 1
Continued ART Regimen	Change From Baseline in BMI	Change from baseline to week 96	0.9 kg/m^2	Standard Error 1.3

Secondary

Change From Baseline in Body Weight

Time frame: 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

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Change From Baseline in Body Weight	Change from baseline to week 48	0.7 Body weight, kg	Standard Error 2.1
DTG/RPV FDC Regimen	Change From Baseline in Body Weight	Change from week 48 to week 96	1.7 Body weight, kg	Standard Error 2.2
DTG/RPV FDC Regimen	Change From Baseline in Body Weight	Change from baseline to week 96	2.4 Body weight, kg	Standard Error 3
Continued ART Regimen	Change From Baseline in Body Weight	Change from baseline to week 48	1.3 Body weight, kg	Standard Error 3.1
Continued ART Regimen	Change From Baseline in Body Weight	Change from week 48 to week 96	1.3 Body weight, kg	Standard Error 3.4
Continued ART Regimen	Change From Baseline in Body Weight	Change from baseline to week 96	2.6 Body weight, kg	Standard Error 4.5

Secondary

Change From Baseline in CD4

Time frame: 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

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Change From Baseline in CD4	Change from baseline to week 48	-31.7 CD4 count cells/mm^3	Standard Error 34.8
DTG/RPV FDC Regimen	Change From Baseline in CD4	Change from week 48 to week 96	27.3 CD4 count cells/mm^3	Standard Error 36.3
DTG/RPV FDC Regimen	Change From Baseline in CD4	Change from baseline to week 96	-4.4 CD4 count cells/mm^3	Standard Error 47.1
Continued ART Regimen	Change From Baseline in CD4	Change from baseline to week 48	9.2 CD4 count cells/mm^3	Standard Error 51
Continued ART Regimen	Change From Baseline in CD4	Change from week 48 to week 96	-9.8 CD4 count cells/mm^3	Standard Error 55.3
Continued ART Regimen	Change From Baseline in CD4	Change from baseline to week 96	-0.7 CD4 count cells/mm^3	Standard Error 71

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

Time frame: 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

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	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
Continued ART Regimen	Change From Baseline in CD8 Cell Count	Change from baseline to week 48	9.7 CD8 cell count: cells/mm^3	Standard Error 60.4
Continued ART Regimen	Change From Baseline in CD8 Cell Count	Change from week 48 to week 96	-55.8 CD8 cell count: cells/mm^3	Standard Error 66.6
Continued ART Regimen	Change From Baseline in CD8 Cell Count	Change from baseline to week 96	-46.1 CD8 cell count: cells/mm^3	Standard Error 81.3

Secondary

Change From Baseline in Glucose

Change from baseline in Glucose

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Change From Baseline in Glucose	Change from baseline to week 48	-0.15 mmol/L	Standard Error 0.16
DTG/RPV FDC Regimen	Change From Baseline in Glucose	Change from week 48 to week 96	0.09 mmol/L	Standard Error 0.17
DTG/RPV FDC Regimen	Change From Baseline in Glucose	Change from baseline to week 96	-0.06 mmol/L	Standard Error 0.21
Continued ART Regimen	Change From Baseline in Glucose	Change from baseline to week 48	-0.06 mmol/L	Standard Error 0.23
Continued ART Regimen	Change From Baseline in Glucose	Change from week 48 to week 96	-0.11 mmol/L	Standard Error 0.25
Continued ART Regimen	Change From Baseline in Glucose	Change from baseline to week 96	-0.17 mmol/L	Standard Error 0.31

Secondary

Change From Baseline in Sodium

Change from baseline in Sodium

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Change From Baseline in Sodium	Change from baseline to week 48	0.3 mmol/L	Standard Error 0.3
DTG/RPV FDC Regimen	Change From Baseline in Sodium	Change from week 48 to week 96	-0.5 mmol/L	Standard Error 0.3
DTG/RPV FDC Regimen	Change From Baseline in Sodium	Change from baseline to week 96	-0.2 mmol/L	Standard Error 0.3
Continued ART Regimen	Change From Baseline in Sodium	Change from baseline to week 48	-0.8 mmol/L	Standard Error 0.4
Continued ART Regimen	Change From Baseline in Sodium	Change from week 48 to week 96	0.3 mmol/L	Standard Error 0.4
Continued ART Regimen	Change From Baseline in Sodium	Change from baseline to week 96	-0.5 mmol/L	Standard Error 0.5

Secondary

Changes in Blood Cell Counts - Haemoglobin

Haemoglobin count evaluation

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Blood Cell Counts - Haemoglobin	Change from baseline to week 48	0.1 g/dL	Standard Error 0.2
DTG/RPV FDC Regimen	Changes in Blood Cell Counts - Haemoglobin	Change from week 48 to week 96	0 g/dL	Standard Error 0.2
DTG/RPV FDC Regimen	Changes in Blood Cell Counts - Haemoglobin	Change from baseline to week 96	0.1 g/dL	Standard Error 0.3
Continued ART Regimen	Changes in Blood Cell Counts - Haemoglobin	Change from baseline to week 48	0 g/dL	Standard Error 0.3
Continued ART Regimen	Changes in Blood Cell Counts - Haemoglobin	Change from week 48 to week 96	0.2 g/dL	Standard Error 0.3
Continued ART Regimen	Changes in Blood Cell Counts - Haemoglobin	Change from baseline to week 96	0.2 g/dL	Standard Error 0.4

Secondary

Changes in Blood Cell Counts - Platelets

platelet count evaluation

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Blood Cell Counts - Platelets	Change from baseline to week 48	3.4 Platelets 10^9/L	Standard Error 8.2
DTG/RPV FDC Regimen	Changes in Blood Cell Counts - Platelets	Change from week 48 to week 96	0.6 Platelets 10^9/L	Standard Error 8.6
DTG/RPV FDC Regimen	Changes in Blood Cell Counts - Platelets	Change from baseline to week 96	4.0 Platelets 10^9/L	Standard Error 11.1
Continued ART Regimen	Changes in Blood Cell Counts - Platelets	Change from baseline to week 48	-2.6 Platelets 10^9/L	Standard Error 12.1
Continued ART Regimen	Changes in Blood Cell Counts - Platelets	Change from week 48 to week 96	9.3 Platelets 10^9/L	Standard Error 13.1
Continued ART Regimen	Changes in Blood Cell Counts - Platelets	Change from baseline to week 96	6.7 Platelets 10^9/L	Standard Error 16.8

Secondary

Changes in Blood Cell Counts - Red Blood Cells

red blood cell count evaluation

Time frame: 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

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	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
Continued ART Regimen	Changes in Blood Cell Counts - Red Blood Cells	Change from baseline to week 48	-0.07 Red Blood Cells 10^12/L	Standard Error 0.09
Continued ART Regimen	Changes in Blood Cell Counts - Red Blood Cells	Change from week 48 to week 96	0.19 Red Blood Cells 10^12/L	Standard Error 0.1
Continued ART Regimen	Changes in Blood Cell Counts - Red Blood Cells	Change from baseline to week 96	0.12 Red Blood Cells 10^12/L	Standard Error 0.13

Secondary

Changes in Blood Cell Counts - White Blood Cells

white blood cell count evaluation

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	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
Continued ART Regimen	Changes in Blood Cell Counts - White Blood Cells	Change from baseline to week 48	-0.06 White Blood Cells 10^12/L	Standard Error 0.38
Continued ART Regimen	Changes in Blood Cell Counts - White Blood Cells	Change from week 48 to week 96	-0.03 White Blood Cells 10^12/L	Standard Error 0.41
Continued ART Regimen	Changes in Blood Cell Counts - White Blood Cells	Change from baseline to week 96	-0.09 White Blood Cells 10^12/L	Standard Error 0.51

Secondary

Changes in Bone Markers - Alkaline Phosphatase

Bone markers evaluation - Alkaline phosphatase

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Bone Markers - Alkaline Phosphatase	Change from baseline to week 48	-5.3 U/L	Standard Error 3
DTG/RPV FDC Regimen	Changes in Bone Markers - Alkaline Phosphatase	Change from week 48 to week 96	3.1 U/L	Standard Error 3.1
DTG/RPV FDC Regimen	Changes in Bone Markers - Alkaline Phosphatase	Change from baseline to week 96	-2.2 U/L	Standard Error 4
Continued ART Regimen	Changes in Bone Markers - Alkaline Phosphatase	Change from baseline to week 48	-1.5 U/L	Standard Error 4.3
Continued ART Regimen	Changes in Bone Markers - Alkaline Phosphatase	Change from week 48 to week 96	-2.5 U/L	Standard Error 4.7
Continued ART Regimen	Changes in Bone Markers - Alkaline Phosphatase	Change from baseline to week 96	-4.0 U/L	Standard Error 6

Secondary

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

Fasting lipids level evaluation - HDL

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Fasting Lipids From Baseline - High Density Lipoprotein (HDL)	Change from baseline to week 48	0.06 mmol/L	Standard Error 0.05
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	Changes in Fasting Lipids From Baseline - High Density Lipoprotein (HDL)	Change from baseline to week 96	0.03 mmol/L	Standard Error 0.06
Continued ART Regimen	Changes in Fasting Lipids From Baseline - High Density Lipoprotein (HDL)	Change from baseline to week 48	0.03 mmol/L	Standard Error 0.07
Continued ART Regimen	Changes in Fasting Lipids From Baseline - High Density Lipoprotein (HDL)	Change from week 48 to week 96	0.01 mmol/L	Standard Error 0.08
Continued ART Regimen	Changes in Fasting Lipids From Baseline - High Density Lipoprotein (HDL)	Change from baseline to week 96	0.04 mmol/L	Standard Error 0.1

Secondary

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

Fasting lipids level evaluation - LDL

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Fasting Lipids From Baseline - Low Density Lipoprotein (LDL)	Change from baseline to week 48	-0.05 mmol/L	Standard Error 0.12
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	Changes in Fasting Lipids From Baseline - Low Density Lipoprotein (LDL)	Change from baseline to week 96	-0.02 mmol/L	Standard Error 0.15
Continued ART Regimen	Changes in Fasting Lipids From Baseline - Low Density Lipoprotein (LDL)	Change from baseline to week 96	-0.14 mmol/L	Standard Error 0.23
Continued ART Regimen	Changes in Fasting Lipids From Baseline - Low Density Lipoprotein (LDL)	Change from baseline to week 48	0 mmol/L	Standard Error 0.18
Continued ART Regimen	Changes in Fasting Lipids From Baseline - Low Density Lipoprotein (LDL)	Change from week 48 to week 96	-0.14 mmol/L	Standard Error 0.19

Secondary

Changes in Fasting Lipids From Baseline - Total Cholesterol

Fasting lipids level evaluation - total cholesterol

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Fasting Lipids From Baseline - Total Cholesterol	Change from baseline to week 48	-0.09 mmol/L	Standard Error 0.14
DTG/RPV FDC Regimen	Changes in Fasting Lipids From Baseline - Total Cholesterol	Change from week 48 to week 96	0.02 mmol/L	Standard Error 0.15
DTG/RPV FDC Regimen	Changes in Fasting Lipids From Baseline - Total Cholesterol	Change from baseline to week 96	-0.07 mmol/L	Standard Error 0.18
Continued ART Regimen	Changes in Fasting Lipids From Baseline - Total Cholesterol	Change from baseline to week 48	0.05 mmol/L	Standard Error 0.2
Continued ART Regimen	Changes in Fasting Lipids From Baseline - Total Cholesterol	Change from week 48 to week 96	-0.19 mmol/L	Standard Error 0.22
Continued ART Regimen	Changes in Fasting Lipids From Baseline - Total Cholesterol	Change from baseline to week 96	-0.13 mmol/L	Standard Error 0.27

Secondary

Changes in Fasting Lipids From Baseline - Triglycerides

Fasting lipids level evaluation - triglycerides

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Fasting Lipids From Baseline - Triglycerides	Change from baseline to week 48	-0.26 mmol/L	Standard Error 0.15
DTG/RPV FDC Regimen	Changes in Fasting Lipids From Baseline - Triglycerides	Change from week 48 to week 96	0.14 mmol/L	Standard Error 0.15
DTG/RPV FDC Regimen	Changes in Fasting Lipids From Baseline - Triglycerides	Change from baseline to week 96	-0.12 mmol/L	Standard Error 0.18
Continued ART Regimen	Changes in Fasting Lipids From Baseline - Triglycerides	Change from baseline to week 48	-0.02 mmol/L	Standard Error 0.22
Continued ART Regimen	Changes in Fasting Lipids From Baseline - Triglycerides	Change from week 48 to week 96	-0.16 mmol/L	Standard Error 0.23
Continued ART Regimen	Changes in Fasting Lipids From Baseline - Triglycerides	Change from baseline to week 96	-0.18 mmol/L	Standard Error 0.27

Secondary

Changes in Liver Levels - Alanine Aminotransferase (ALT)

Liver level evaluation - ALT

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Liver Levels - Alanine Aminotransferase (ALT)	Change from baseline to week 48	2.4 U/L	Standard Error 3.2
DTG/RPV FDC Regimen	Changes in Liver Levels - Alanine Aminotransferase (ALT)	Change from week 48 to week 96	-0.7 U/L	Standard Error 3.4
DTG/RPV FDC Regimen	Changes in Liver Levels - Alanine Aminotransferase (ALT)	Change from baseline to week 96	1.8 U/L	Standard Error 3.7
Continued ART Regimen	Changes in Liver Levels - Alanine Aminotransferase (ALT)	Change from baseline to week 48	-0.6 U/L	Standard Error 4.7
Continued ART Regimen	Changes in Liver Levels - Alanine Aminotransferase (ALT)	Change from week 48 to week 96	1.1 U/L	Standard Error 5.1
Continued ART Regimen	Changes in Liver Levels - Alanine Aminotransferase (ALT)	Change from baseline to week 96	0.6 U/L	Standard Error 5.6

Secondary

Changes in Liver Levels - Bilirubin

Liver level evaluation - bilirubin

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Liver Levels - Bilirubin	Change from baseline to week 48	-0.6 umol/L	Standard Error 1.4
DTG/RPV FDC Regimen	Changes in Liver Levels - Bilirubin	Change from week 48 to week 96	-1.3 umol/L	Standard Error 1.4
DTG/RPV FDC Regimen	Changes in Liver Levels - Bilirubin	Change from baseline to week 96	-1.9 umol/L	Standard Error 1.4
Continued ART Regimen	Changes in Liver Levels - Bilirubin	Change from baseline to week 48	-1.9 umol/L	Standard Error 2
Continued ART Regimen	Changes in Liver Levels - Bilirubin	Change from week 48 to week 96	-2.2 umol/L	Standard Error 2.2
Continued ART Regimen	Changes in Liver Levels - Bilirubin	Change from baseline to week 96	-4.1 umol/L	Standard Error 2.1

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.

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Patient Satisfaction - HIV Treatment Satisfaction Questionnaire (HIVTSQs)	Change from baseline to week 48	1.6 Global satisfaction score	Standard Error 0.6
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	Changes in Patient Satisfaction - HIV Treatment Satisfaction Questionnaire (HIVTSQs)	Change from baseline to week 96	1.8 Global satisfaction score	Standard Error 0.7
Continued ART Regimen	Changes in Patient Satisfaction - HIV Treatment Satisfaction Questionnaire (HIVTSQs)	Change from baseline to week 48	0.7 Global satisfaction score	Standard Error 0.9
Continued ART Regimen	Changes in Patient Satisfaction - HIV Treatment Satisfaction Questionnaire (HIVTSQs)	Change from week 48 to week 96	0.4 Global satisfaction score	Standard Error 1
Continued ART Regimen	Changes in Patient Satisfaction - HIV Treatment Satisfaction Questionnaire (HIVTSQs)	Change from baseline to week 96	1.1 Global satisfaction score	Standard Error 1.1

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

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	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
Continued ART Regimen	Changes in Pittsburgh Sleep Quality Index (PSQI)	Change from baseline to week 48	-0.7 Global PSQI score on a scale	Standard Error 0.5
Continued ART Regimen	Changes in Pittsburgh Sleep Quality Index (PSQI)	Change from week 48 to week 96	-0.5 Global PSQI score on a scale	Standard Error 0.5
Continued ART Regimen	Changes in Pittsburgh Sleep Quality Index (PSQI)	Change from baseline to week 96	-1.2 Global PSQI score on a scale	Standard Error 0.5

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.

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Quality of Life Health Status Score	Change from baseline to week 48	1.7 score on a scale	Standard Error 2.9
DTG/RPV FDC Regimen	Changes in Quality of Life Health Status Score	Change from week 48 to week 96	-2.0 score on a scale	Standard Error 3
DTG/RPV FDC Regimen	Changes in Quality of Life Health Status Score	Change from baseline to week 96	-0.3 score on a scale	Standard Error 3.3
Continued ART Regimen	Changes in Quality of Life Health Status Score	Change from baseline to week 48	6.3 score on a scale	Standard Error 4.3
Continued ART Regimen	Changes in Quality of Life Health Status Score	Change from week 48 to week 96	-7.2 score on a scale	Standard Error 4.6
Continued ART Regimen	Changes in Quality of Life Health Status Score	Change from baseline to week 96	-0.9 score on a scale	Standard Error 5

Secondary

Changes in Renal Markers - Creatinine

Renal markers evaluation - creatinine

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Renal Markers - Creatinine	Change from baseline to week 48	3.0 umol/L	Standard Error 2.3
DTG/RPV FDC Regimen	Changes in Renal Markers - Creatinine	Change from week 48 to week 96	0.3 umol/L	Standard Error 2.4
DTG/RPV FDC Regimen	Changes in Renal Markers - Creatinine	Change from baseline to week 96	3.3 umol/L	Standard Error 3.1
Continued ART Regimen	Changes in Renal Markers - Creatinine	Change from baseline to week 48	0.3 umol/L	Standard Error 3.4
Continued ART Regimen	Changes in Renal Markers - Creatinine	Change from week 48 to week 96	5.5 umol/L	Standard Error 3.7
Continued ART Regimen	Changes in Renal Markers - Creatinine	Change from baseline to week 96	5.8 umol/L	Standard Error 4.7

Secondary

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

Renal markers evaluation- creatinine clearance (eGFR)

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	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
DTG/RPV FDC Regimen	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
Continued ART Regimen	Changes in Renal Markers - Creatinine Clearance (Estimated Glomerular Filtration Rate(eGFR))	Change from baseline to week 48	-1.3 eGFR mL/min	Standard Error 3.3
Continued ART Regimen	Changes in Renal Markers - Creatinine Clearance (Estimated Glomerular Filtration Rate(eGFR))	Change from week 48 to week 96	-3.4 eGFR mL/min	Standard Error 3.6
Continued ART Regimen	Changes in Renal Markers - Creatinine Clearance (Estimated Glomerular Filtration Rate(eGFR))	Change from baseline to week 96	-4.7 eGFR mL/min	Standard Error 4.2

Secondary

Changes in Vital Signs From Baseline - Diastolic Blood Pressure

Changes in Vital Signs from baseline - Diastolic Blood Pressure

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Vital Signs From Baseline - Diastolic Blood Pressure	Change from baseline to week 48	0.2 mmHg	Standard Error 1.5
DTG/RPV FDC Regimen	Changes in Vital Signs From Baseline - Diastolic Blood Pressure	Change from week 48 to week 96	-0.7 mmHg	Standard Error 1.6
DTG/RPV FDC Regimen	Changes in Vital Signs From Baseline - Diastolic Blood Pressure	Change from baseline to week 96	-0.5 mmHg	Standard Error 1.8
Continued ART Regimen	Changes in Vital Signs From Baseline - Diastolic Blood Pressure	Change from baseline to week 48	3.1 mmHg	Standard Error 2.2
Continued ART Regimen	Changes in Vital Signs From Baseline - Diastolic Blood Pressure	Change from week 48 to week 96	0.8 mmHg	Standard Error 2.4
Continued ART Regimen	Changes in Vital Signs From Baseline - Diastolic Blood Pressure	Change from baseline to week 96	4.0 mmHg	Standard Error 2.7

Secondary

Changes in Vital Signs From Baseline - Pulse Rate

Changes in Vital Signs from baseline - Pulse rate

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Vital Signs From Baseline - Pulse Rate	Change from baseline to week 48	2.1 beats per minute	Standard Error 1.6
DTG/RPV FDC Regimen	Changes in Vital Signs From Baseline - Pulse Rate	Change from week 48 to week 96	-2.5 beats per minute	Standard Error 1.8
DTG/RPV FDC Regimen	Changes in Vital Signs From Baseline - Pulse Rate	Change from baseline to week 96	-0.4 beats per minute	Standard Error 2
Continued ART Regimen	Changes in Vital Signs From Baseline - Pulse Rate	Change from baseline to week 48	2.7 beats per minute	Standard Error 2.4
Continued ART Regimen	Changes in Vital Signs From Baseline - Pulse Rate	Change from week 48 to week 96	-1.5 beats per minute	Standard Error 2.6
Continued ART Regimen	Changes in Vital Signs From Baseline - Pulse Rate	Change from baseline to week 96	1.2 beats per minute	Standard Error 2.9

Secondary

Changes in Vital Signs From Baseline - Systolic Blood Pressure

Changes in Vital Signs from baseline - Systolic Blood Pressure

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in Vital Signs From Baseline - Systolic Blood Pressure	Change from baseline to week 48	-1.4 mmHg	Standard Error 2.2
DTG/RPV FDC Regimen	Changes in Vital Signs From Baseline - Systolic Blood Pressure	Change from week 48 to week 96	-0.1 mmHg	Standard Error 2.3
DTG/RPV FDC Regimen	Changes in Vital Signs From Baseline - Systolic Blood Pressure	Change from baseline to week 96	-1.5 mmHg	Standard Error 2.7
Continued ART Regimen	Changes in Vital Signs From Baseline - Systolic Blood Pressure	Change from baseline to week 96	10.5 mmHg	Standard Error 4.1
Continued ART Regimen	Changes in Vital Signs From Baseline - Systolic Blood Pressure	Change from baseline to week 48	4.9 mmHg	Standard Error 3.3
Continued ART Regimen	Changes in Vital Signs From Baseline - Systolic Blood Pressure	Change from week 48 to week 96	5.6 mmHg	Standard Error 3.6

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)

Time frame: 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

Arm	Measure	Group	Value (MEDIAN)
DTG/RPV FDC Regimen	Number of Drug Drug Interactions	Baseline	1 Number of Drug Interactions
DTG/RPV FDC Regimen	Number of Drug Drug Interactions	Week 24	1 Number of Drug Interactions
DTG/RPV FDC Regimen	Number of Drug Drug Interactions	Week 48	1 Number of Drug Interactions
DTG/RPV FDC Regimen	Number of Drug Drug Interactions	Week 96	1 Number of Drug Interactions
Continued ART Regimen	Number of Drug Drug Interactions	Week 96	0 Number of Drug Interactions
Continued ART Regimen	Number of Drug Drug Interactions	Baseline	1 Number of Drug Interactions
Continued ART Regimen	Number of Drug Drug Interactions	Week 48	0 Number of Drug Interactions
Continued ART Regimen	Number of Drug Drug Interactions	Week 24	NA Number of Drug Interactions

Secondary

Number of Participants With Adverse Events - Baseline to Week 48

Adverse Events reports (AEs, SAEs and treatment discontinuation)

Time frame: Baseline to week 48

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Grade 1	61 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Drug related AEs	22 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Grade 3-4	7 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Drug related grade 3-4 AEs	1 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Grade 2	43 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Baseline to Week 48	AEs leading to study drug interruption	4 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Missing grade	6 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Baseline to Week 48	SAEs	4 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Any Adverse Events (AEs)	78 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Baseline to Week 48	SAEs	2 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Any Adverse Events (AEs)	33 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Grade 1	25 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Grade 2	13 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Grade 3-4	2 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Missing grade	1 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Drug related AEs	0 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Baseline to Week 48	Drug related grade 3-4 AEs	0 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Baseline to Week 48	AEs leading to study drug interruption	0 Participants

Secondary

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

Adverse Events reports (AEs, SAEs and treatment discontinuation)

Time frame: From Week 48 to week 96

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Grade 1	36 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Drug related AEs	1 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Grade 3-4	5 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Drug related grade 3-4 AEs	0 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Grade 2	20 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	AEs leading to study drug interruption	1 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Missing grade	7 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	SAEs	5 Participants
DTG/RPV FDC Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Any Adverse Events (AEs)	54 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	SAEs	1 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Any Adverse Events (AEs)	28 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Grade 1	18 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Grade 2	12 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Grade 3-4	5 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Missing grade	0 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Drug related AEs	5 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	Drug related grade 3-4 AEs	0 Participants
Continued ART Regimen	Number of Participants With Adverse Events - Week 48 to Week 96	AEs leading to study drug interruption	2 Participants

Secondary

Number of Participants With and Without Virological Suppression

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

Time frame: week 96

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
DTG/RPV FDC Regimen	Number of Participants With and Without Virological Suppression	HIV RNA < 50 copies/mL	80 Participants
DTG/RPV FDC Regimen	Number of Participants With and Without Virological Suppression	HIV RNA >= 50 copies/mL	5 Participants
DTG/RPV FDC Regimen	Number of Participants With and Without Virological Suppression	No virologic data at week 96	10 Participants
Continued ART Regimen	Number of Participants With and Without Virological Suppression	HIV RNA < 50 copies/mL	33 Participants
Continued ART Regimen	Number of Participants With and Without Virological Suppression	HIV RNA >= 50 copies/mL	3 Participants
Continued ART Regimen	Number of Participants With and Without Virological Suppression	No virologic data at week 96	9 Participants

Other Pre-specified

Changes in CD4/CD8 Ratio

CD4/CD8 evaluation

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in CD4/CD8 Ratio	Change from week 48 to week 96	0.04 ratio	Standard Error 0.06
DTG/RPV FDC Regimen	Changes in CD4/CD8 Ratio	Change from Baseline to week 96	0.07 ratio	Standard Error 0.08
DTG/RPV FDC Regimen	Changes in CD4/CD8 Ratio	Change from Baseline to week 48	0.03 ratio	Standard Error 0.06
Continued ART Regimen	Changes in CD4/CD8 Ratio	Change from week 48 to week 96	0 ratio	Standard Error 0.1
Continued ART Regimen	Changes in CD4/CD8 Ratio	Change from Baseline to week 96	0.01 ratio	Standard Error 0.13
Continued ART Regimen	Changes in CD4/CD8 Ratio	Change from Baseline to week 48	0.02 ratio	Standard Error 0.09

Other Pre-specified

Changes in High Sensitivity C-Reactive Protein

High Sensitivity C-Reactive Protein evaluation

Time frame: Changed assessed from baseline to week 48, week 48 to week 96, baseline to week 96

Arm	Measure	Group	Value (MEAN)	Dispersion
DTG/RPV FDC Regimen	Changes in High Sensitivity C-Reactive Protein	Change from baseline to week 48	0.8 mg/L	Standard Error 1.2
DTG/RPV FDC Regimen	Changes in High Sensitivity C-Reactive Protein	Change from week 48 to week 96	0.5 mg/L	Standard Error 1.2
DTG/RPV FDC Regimen	Changes in High Sensitivity C-Reactive Protein	Change from baseline to week 96	1.3 mg/L	Standard Error 1.4
Continued ART Regimen	Changes in High Sensitivity C-Reactive Protein	Change from baseline to week 48	-1.3 mg/L	Standard Error 1.8
Continued ART Regimen	Changes in High Sensitivity C-Reactive Protein	Change from week 48 to week 96	-0.9 mg/L	Standard Error 1.9
Continued ART Regimen	Changes in High Sensitivity C-Reactive Protein	Change from baseline to week 96	-2.2 mg/L	Standard Error 2.1

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants With and Without Virological Suppression

Change From Baseline in BMI

Change From Baseline in Body Weight

Change From Baseline in CD4

Change From Baseline in CD8 Cell Count

Change From Baseline in Glucose

Change From Baseline in Sodium

Changes in Blood Cell Counts - Haemoglobin

Changes in Blood Cell Counts - Platelets

Changes in Blood Cell Counts - Red Blood Cells

Changes in Blood Cell Counts - White Blood Cells

Changes in Bone Markers - Alkaline Phosphatase

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

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

Changes in Fasting Lipids From Baseline - Total Cholesterol

Changes in Fasting Lipids From Baseline - Triglycerides

Changes in Liver Levels - Alanine Aminotransferase (ALT)

Changes in Liver Levels - Bilirubin

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

Changes in Pittsburgh Sleep Quality Index (PSQI)

Changes in Quality of Life Health Status Score

Changes in Renal Markers - Creatinine

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

Changes in Vital Signs From Baseline - Diastolic Blood Pressure

Changes in Vital Signs From Baseline - Pulse Rate

Changes in Vital Signs From Baseline - Systolic Blood Pressure

Number of Drug Drug Interactions

Number of Participants With Adverse Events - Baseline to Week 48

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

Number of Participants With and Without Virological Suppression

Changes in CD4/CD8 Ratio

Changes in High Sensitivity C-Reactive Protein