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

CompletedPhase 2

Sponsor: PENTA Foundation

Conditions: HIV Infection

Interventions: dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen, Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF)

Countries: Uganda, Zimbabwe

This study aims to find out whether treating children living with HIV with three anti-HIV medicines, dolutegravir (DTG), emtricitabine (FTC) and tenofovir alafenamide (TAF), with a novel dose ratio will achieve adequate drug concentrations and is safe. The optimal DTG/FTC/TAF dose ratio will be used for the development of a fixed-dose combination dispersible tablet.

Eligibility overview

Sex: ALL

Age: 28 Days to 10 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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 to INSTI or NRTI

Locations (3)

Kampala, Uganda
Kampala, Uganda
Harare, Zimbabwe