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

NCT05993767 | Completed Phase 2 DMC

• 2 other identifiers: UNIVERSAL1RIA2019PD-2882
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (8)

• Primary endpoints for DTG:

  \- Geometric mean Ctrough concentration

  From enrollment to the end of treatment at 24 weeks

• Primary endpoints for DTG:

  Percentage of individual Ctrough concentrations below the 90% effective concentration (EC90) (0.32 mg/L)

  From enrollment to the end of treatment at 24 weeks

• Primary endpoints for DTG:

  \- Geometric mean DTG Ctrough, Cmax, and AUC

  From enrollment to the end of treatment at 24 weeks

• Primary safety endpoints

  \- Occurrence of serious adverse events

  From enrollment to the end of treatment at 24 weeks

• Primary safety endpoints

  \- Occurrence of new clinical and laboratory grade 3 and 4 adverse events

  From enrollment to the end of treatment at 24 weeks

• Primary safety endpoints

  Occurrence of adverse events (of any grade) leading to treatment modification

  From enrollment to the end of treatment at 24 weeks

• Primary endpoints for FTC/TAF:

  \- Geometric mean Ctrough, Cmax, and AUC

  From enrollment to the end of treatment at 24 weeks

• Primary endpoints for FTC/TAF:

  Intracellular tenofovir diphosphate (TDP) levels at 24 hours acquired through dried blood spot analysis

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (2)

• Efficacy endpoints

  From enrollment to the end of treatment at 24 weeks

• Efficacy endpoints

  From enrollment to the end of treatment at 24 weeks

Study Arms (1)

dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen

EXPERIMENTAL

Switch or start dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen with a novel dose ratio for HIV treatment. Subjects will receive DTG 10 mg dispersible tablets and FTC/TAF 15/1.88 mg dispersible tablets or DTG 50 mg film coated tablets and FTC/TAF 200/25 mg film coated tablets depending on weight band

Drug: dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen; Drug: Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF)

Interventions

Dolutegravir (DTG)/ Emtricitabine (FTC)/tenofovir alafenamide (TAF) DRUG

Single arm

dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen

dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen DRUG

Switch or start dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen with a novel dose ratio for HIV treatment

dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen

Eligibility Criteria

• Age: 28 Days - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: collaborator
• PENTA Foundation: lead
• Radboud University Medical Center: collaborator
• Clinton Health Access Initiative Inc.: collaborator
• University of Zimbabwe: collaborator
• Chiang Mai University: collaborator
• Joint Clinical Research Center: collaborator

Study Sites (3)

Baylor College of Medicine Children's Foundation

Kampala, Uganda

Location

Joint Research Centre

Kampala, Uganda

Location

University of Zimbabwe Clinical Research Centre

Harare, Zimbabwe

Location

MeSH Terms

Conditions

HIV Infections

Interventions

dolutegravir; Clinical Protocols; Emtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: An interventional, phase I/II, multicenter, single-arm study

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 15, 2023
• Study Start: December 11, 2024
• Primary Completion: June 30, 2025
• Study Completion: January 20, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ZI (1); UG (2)