HIV/AIDS
Conditions
Interventions
DTG FTC TAF and TFV
Sponsors
Fondazione Penta ETS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 28 days to =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 antiretroviral therapy (ART) regimen should be virologically suppressed, or within 6 months after start treatment, at screening
Exclusion criteria
Exclusion criteria: - History or presence of known allergy to DTG, FTC or TAF - Alanine aminotransferase (ALT) =5 times the upper limit of normal (ULN), OR ALT =3xULN AND bilirubin =2xULN - 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) - 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 - Known resistance for INSTI or NRTI for naïve patients (see appendix V) - Clinician concern for significant poor adherence in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics and short-term safety of DTG and FTC/TAF administered to children living with HIV using a novel dose ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the short-term efficacy of DTG and FTC/TAF formulations in children using a novel dose ratio | — |
Countries
Uganda, Zimbabwe
Contacts
Public ContactAlessandra Nardone
Fondazione Penta ETS
Outcome results
None listed