UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children

Korábbi kezelés

• Current or anticipated need for TB therapy during the study
• Use of rifampicin-based therapy within 4 weeks before start trial
• Presence of comedication known to interact with trial medications

Más betegség

• Confirmed HIV-1 infection (local, molecular methods)
• Subject is willing to start DTG/FTC/TAF regimen in the novel dose ratio for HIV treatment
• History or presence of known allergy to DTG, FTC or TAF
• Patients with severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)

Laborértékek

• Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), OR ALT ≥3xULN AND bilirubin ≥2xULN

Életkor

• Age between 28 days and 10 years old
• Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation in the study

Egyéb

• Weighing 3 to <25 kg
• A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol
• Girls who have reached menarche must have a negative pregnancy test at screening
• Subjects already on a DTG-based ART regimen should be virologically suppressed at screening
• Known resistance to INSTI or NRTI

• Age between 28 days and 10 years old
• Weighing 3 to <25 kg
• Confirmed HIV-1 infection (local, molecular methods)
• A parent or legal guardian is willing and able to give informed consent on behalf of the child as per national legislation and willing to adhere to the protocol
• Participant is willing to give informed assent if the trial site clinician deems them old enough and able to understand the age-appropriate information about participation in the study
• Girls who have reached menarche must have a negative pregnancy test at screening
• Subject is willing to start DTG/FTC/TAF regimen in the novel dose ratio for HIV treatment
• Subjects already on a DTG-based ART regimen should be virologically suppressed at screening