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

NCT06139796 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2026-03-05

No results posted yet for this study

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

Interventions

DRUG

DRV/r FDC (120/20mg)

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

Sponsors & Collaborators

  • AMS-PHPT Research Collaboration

    collaborator UNKNOWN

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

    collaborator OTHER_GOV

  • Centre Mère et Enfant de la Fondation Chantal Biya

    collaborator OTHER

  • Centre Hospitalier National d'Enfants Albert Royer

    collaborator UNKNOWN

  • University of Zimbabwe Clinical Research Centre (UZCRC)

    collaborator UNKNOWN

  • Baylor College of Medicine

    collaborator OTHER

  • PENTA Foundation

    lead NETWORK

Principal Investigators

  • Albert Faye · Hôpital Robert Debré and Université Paris Cité

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-07-09
Completion
2025-07-09

Countries

  • Cameroon
  • Senegal
  • Uganda
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06139796 on ClinicalTrials.gov