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Status:

WITHDRAWN

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

Lead Sponsor:

PENTA Foundation

Collaborating Sponsors:

AMS-PHPT Research Collaboration

Institut National de la Santé Et de la Recherche Médicale, France

Conditions:

HIV Infections

Eligibility:

All Genders

3-17 years

Phase:

PHASE1

PHASE2

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 ...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

  • • 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-specific inclusion criteria:
  • 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

Exclusion

  • 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, …).

Key Trial Info

Start Date :

February 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 9 2025

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT06139796

Start Date

February 1 2025

End Date

July 9 2025

Last Update

September 2 2025

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Centre Mère et Enfant de la Fondation Chantal Biya

Yaoundé, Cameroon, Cameroon, 1

2

Centre Hospitalier National d'Enfants Albert Royer

Dakar, Senegal, Senegal, 25755

3

Baylor College of Medicine Children's Foundation

Kampala, Uganda, Uganda, 72052

4

Joint Clinical Research Centre (JCRC)

Kampala, Uganda