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NCT06139796

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

Pharmacokinetics, Safety and Acceptability of a Solid Paediatric Fixed-dose Combination of Darunavir/Ritonavir (DRV/r) 120/20 mg for Children Living With HIV
PENTA Foundation·Phase 1/2·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
HIV Infections
Drug/Device/Intervention
DRV/r FDC (120/20mg)
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
PENTA Foundation
Timeline & enrollment
Phase
Phase 1/2
Start date
Jun 01, 2024
End date
Jun 01, 2026
Enrollment
50 participants
Primary outcome

Pharmacokinetics Darunavir,Pharmacokinetics Darunavir,Pharmacokinetics Darunavir,Pharmacokinetics Darunavir,Safety events,Safety events,Safety events,Safety events

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.

ICD-10 classifications
HIV disease resulting in other viral infectionsHIV disease resulting in other bacterial infectionsHIV disease resulting in multiple infectionsAcute HIV infection syndromeHIV disease resulting in other infectious and parasitic diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06139796
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06139796 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by PENTA Foundation and is currently Not yet recruiting. The study focuses on HIV Infections. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.