Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV

NCT06139796 | Withdrawn Phase 1 DMC

• 1 other identifier: UNIVERSAL2
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 5

Brief Summary

The UNIVERSAL2 study is a research project designed to evaluate a newly developed formulation of an approved drug for children living with HIV aged over 3 years and weighing between 10 and 25 kg. The aim of UNIVERSAL2 is to determine the right dosage of this new formulation.

Conditions

HIV Infections

Keywords

HIV; Darunavir; Ritonavir; Paediatrics; new formulation

Outcome Measures

Primary Outcomes (8)

• Pharmacokinetics Darunavir

  area under the concentration-time curve (AUC0-12) (Cohort A)

  From enrollment to the end of treatment at 24 weeks

• Pharmacokinetics Darunavir

  area under the concentration-time curve (AUC0-24) (Cohort B)

  From enrollment to the end of treatment at 24 weeks

• Pharmacokinetics Darunavir

  maximum plasma concentration (Cmax)

  From enrollment to the end of treatment at 24 weeks

• Pharmacokinetics Darunavir

  12 hours or 24 hours post dose concentrations (C12 or C24)

  From enrollment to the end of treatment at 24 weeks

• Safety events

  serious adverse events (SAEs)

  From enrollment to the end of treatment at 24 weeks

• Safety events

  adverse events (AEs) of Grade 3 or higher

  From enrollment to the end of treatment at 24 weeks

• Safety events

  treatment related AEs

  From enrollment to the end of treatment at 24 weeks

• Safety events

  AEs leading to treatment discontinuation or modification

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (5)

• Acceptability

  From enrollment to the end of treatment at 24 weeks

• Efficacy of treatment

  From enrollment to the end of treatment at 24 weeks

• Efficacy of treatment

  From enrollment to the end of treatment at 24 weeks

• Efficacy of treatment

  From enrollment to the end of treatment at 24 weeks

• Pharmacokinetics Ritonavir

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Cohort A Twice daily

EXPERIMENTAL

DRV/r twice daily (BID): 30 children with 1 or 2 DRV RAM\* weighing 10 to \<25 kg (10 per weight band: 10-13.9kg, 14-19.9kg, 20-24.9kg)

Drug: DRV/r FDC (120/20mg)

Cohort B Once daily

EXPERIMENTAL

DRV/r once daily (OD): 20 children with no DRV RAM\* weighing 10 to \<20 kg (10 per weight band: 10-13.9kg, 14-19.9kg) \*DRV RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V

Drug: DRV/r FDC (120/20mg)

Interventions

DRV/r FDC (120/20mg) DRUG

Initiation of DRV/r FDC (120/20mg) as part of antiretroviral therapy (ART) with an Optimized Background Therapy (OBT)

Cohort A Twice daily; Cohort B Once daily

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Confirmed HIV-1 infection
• Aged ≥ 3 years
• With unsuppressed viral load (HIV-1 RNA viral load \> 1000 c/mL) on ART-regimen and eligible to switch to new DRV/r 120/20 mg-based regimen per investigator's judgement
• Able to swallow the 120/20 mg DRV/r tablets
• Willing to receive the 120/20 mg DRV/r tablets
• Parents or guardians, and children where appropriate, willing and able to give informed consent and to adhere to the protocol
• Cohort A:
• Have 1 or 2 DRV resistance-associated mutations (RAMs)\*
• Weigh 10 to \<25 kg at screening
• Cohort B:
• Have no DRV RAMs\*
• Weigh 10 to \<20 kg at screening. \*DRV RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V

You may not qualify if:

• Presence of \>2 darunavir RAMs\*
• Failure of protease genotypic resistance testing at baseline, except if treatment history indicates that it is very unlikely
• Resistance to all NRTI available in the country or impossibility to define an OBT
• Intercurrent illness (enrolment can take place after the illness resolves)
• Creatinine ≥ 1.8 Upper Limit of Normal (ULN) or ALT ≥ 5 ULN or (ALT ≥ 3 ULN and bilirubin ≥2 ULN) at screening.
• Severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice), or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
• History or presence of known allergy or other contraindication to DRV/r or their components as described in the Summary of Product Characteristics (SmPC)
• Concomitant medications that may interact with the current antiretroviral treatment, in particular TB drugs (i.e: rifampicin, rifabutin, rifapentine, …).

Sponsors & Collaborators

• University of Zimbabwe Clinical Research Centre (UZCRC): collaborator
• Baylor College of Medicine: collaborator
• PENTA Foundation: lead
• AMS-PHPT Research Collaboration: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Centre Mère et Enfant de la Fondation Chantal Biya: collaborator
• Centre Hospitalier National d'Enfants Albert Royer: collaborator

Study Sites (5)

Centre Mère et Enfant de la Fondation Chantal Biya

Yaoundé, Cameroon, 1, Cameroon

Location

Centre Hospitalier National d'Enfants Albert Royer

Dakar, Senegal, 25755, Senegal

Location

Baylor College of Medicine Children's Foundation

Kampala, Uganda, 72052, Uganda

Location

Joint Clinical Research Centre (JCRC)

Kampala, Uganda

Location

University of Zimbabwe Clinical Research Centre (UZCRC)

Harare, Zimbabwe, Zimbabwe

Location

MeSH Terms

Conditions

HIV Infections

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

Study Officials

• Albert Faye

  Hôpital Robert Debré and Université Paris Cité

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Open-label, multi-centre, single-arm, phase I/II study

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: February 1, 2025
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); UG (2); CA (1); ZI (1)