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CT272/2024

NCT05993767
21-08-2023

Pharmacokinetic study of a novel DTG/FTC/TAF dose ratio for children

Pharmacokinetic study of an optimized dose ratio of dolutegravir/emtricitabine/tenofovir alafenamide fumarate: expediting a UNIVERSAL first line regimen for all children living with HIV in Africa

Primary Sponsor Details
Fondazione Penta ETS

Secondary Sponsor Details
: Ennie Chidziva
UZ CRC Trial Manager
echidziva@uzcrc.org
0772924389
2 Corner Mazowe Street and Allan Wilson Drive, Harare
University of Zimbabwe Clinical Research Centre
Prof Hilda Angela Mujuru
Principal Investigator
hmujuru@mweb.co.zw
0712600791
2 Corner Mazowe Street and Allen Wilson Drive, Harare
UZ CRC

Zimbabwe and Uganda.
: Fondazione Penta ETS
HIV infection
DTG 10 mg dispersible tablets FTC/TAF 15/1.88 mg dispersible tablets DTG 50 mg film coated tablets FTC/TAF 200/25 mg film coated tablets
The study drugs will be ordered from the sponsor intermittently as the study progresses. The quantities ordered will be determined by the participant recruitment rate and duration of follow-up.

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 

- 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 naìˆve patients (see appendix V)
- Clinician concern for significant poor adherence in the past 
  1. Primary endpoints for DTG:
    - Geometric mean plasma concentration 24h after observed intake (C24)
    - Percentage of individual plasma C24 concentrations below the 90% effective concentration (EC90) (0.32 mg/L)
    - Geometric mean DTG plasma maximum concentration (Cmax), and the area under the concentration-time curve over the dosing interval (AUC0-24h) 
  2. Primary endpoints for FTC/TAF:
    - Geometric mean plasma FTC, TAF, TFV C24 (Clast for TAF), Cmax, and AUC0-24h 
9.0 DESIGN OF THE TRIAL
Opened

If controlled
Yes
UNIVERSAL1 is an interventional, phase II, multicenter, single-arm study. A total of 50 children will be enrolled over approximately 9 months. A short-term follow-up of 24 weeks will be conducted. All children enrolled will be participating in the intens
No
No
No
Yes
25
N/A
50
15 months in total (9 months enrolment/study accrual)