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

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 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 =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 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