Study not started as the IMP is re-worked by the manufacturer
UNIVERSAL2
Pharmacokinetics, Safety and Acceptability of a Solid Paediatric Fixed-dose Combination of Darunavir/Ritonavir (DRV/r) 120/20 mg for Children Living With HIV
Sponsor study identifier
interventional
0
4 countries
5
Study Start
February 1, 2025
Actual (reported)Primary Completion
July 9, 2025
Actual (reported)Study Completion
July 9, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 9, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2023
Actual (reported)November 18, 2023
Actual (reported)February 1, 2025
Actual (reported)July 9, 2025
Actual (reported)July 9, 2025
Actual (reported)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
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
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)
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
Initiation of DRV/r FDC (120/20mg) as part of antiretroviral therapy (ART) with an Optimized Background Therapy (OBT)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre Mère et Enfant de la Fondation Chantal Biya
Yaoundé, Cameroon, 1, Cameroon
Centre Hospitalier National d'Enfants Albert Royer
Dakar, Senegal, 25755, Senegal
Baylor College of Medicine Children's Foundation
Kampala, Uganda, 72052, Uganda
Joint Clinical Research Centre (JCRC)
Kampala, Uganda
University of Zimbabwe Clinical Research Centre (UZCRC)
Harare, Zimbabwe, Zimbabwe
Albert Faye
Hôpital Robert Debré and Université Paris Cité
0 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2023
First Posted
November 18, 2023
Study Start
February 1, 2025
Actual (reported)A Study to Evaluate JL18008 in Subject With HIV Immunological Non-Responders
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
Contact the study team to confirm eligibility.
Primary Completion
July 9, 2025
Actual (reported)Study Completion
July 9, 2025
Actual (reported)Last Updated
March 5, 2026
Record last verified: 2026-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: