Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Exclusion Criteria

• •Documented resistance (ever) to Non-nucleoside reverse transcriptase inhibitors (NNRTIs) or integrase inhibitors
• •Documented HIV-1 RNA result greater than or equal to the lower limit of detection of the assay based on a specimen collected in the 12 months (365 days) prior to Screening
• •Any change (ever) of any Antiretroviral (ARV) agent due to virologic failure, as determined by the site investigator based on participant/parent/guardian report and available medical records
• •Has a history (ever) of allergy to DTG, RPV, or any other component of JULUCA as determined by the site investigator based on participant/parent/guardian report and available medical records.
• •Has a history (ever) of congestive heart failure, symptomatic arrhythmia, or any clinically significant cardiac disease as determined by the site investigator based on participant/ parent/guardian report and available medical records
• •Has a history (ever) of unstable liver disease (defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) as determined by the site investigator based on participant/parent/guardian report and available medical records
• •Has any of the following as determined by the site investigator based on participant/ parent/guardian report and available medical records: Current clinical evidence of pancreatitis; Currently active AIDS-defining (WHO Clinical Stage 4) opportunistic infection; Currently active TB and/or current rifamycin-containing TB treatment.
• •Has an anticipated need for any HCV therapy during the first 24 weeks of study and for HCV therapy based on interferon or any drugs that have a potential for adverse drug: drug interactions with study treatment throughout the entire study period.
• •Receipt of the following as determined by the site investigator based on participant/ parent/guardian report and available medical records: Any investigational agent within 90 days prior to entry; Any prohibited medication within 30 days prior to entry; Any medication with a known risk of Torsades de Pointes within seven days prior to entry
• •Receipt (ever) of an ART regimen that included both DTG and RPV, as determined by the site investigator based on participant/parent/guardian report and available medical records
• •Any ≥ grade 3 result for the following based on grading per the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events: Haemoglobin (\<8.5 gram per deciliter \[g/dL\] or \<5.25 millimoles per liter \[mmol/L\]); Absolute neutrophil count (\<600 cells/mm\^3 or \<0.600 x 109 cells/L); Platelet count (\<50,000cells/mm\^3 or \<50.00 x 109 cells/L); Estimated glomerular filtration rate (eGFR: \<60ml/min/1.73m\^2); ALT (≥5.0 x Upper limit of Normal \[ULN\]); Aspartate Aminotransferase (AST) (≥5.0 x ULN)
• •Has the following combination of laboratory test results at screening: Alanine transaminase \[ALT\] greater than or equal to 3 x ULN and total bilirubin greater than or equal to 1.5 x ULN and direct bilirubin greater than 35% of total bilirubin
• •Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening.
• •QTc \>450 milliseconds (msec) at Screening
• •Severe acute malnutrition (Body Mass Index \[BMI\] for age \<-3 or nutritional oedema)
• •Has any documented or suspected clinically significant medical or psychiatric condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
• •The child is a ward of State or government.