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Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV - Trial NCT06139796

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.

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NCT06139796
Phase 1/2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06139796
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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

Study Focus

HIV Infections

DRV/r FDC (120/20mg)

Interventional

drug

Sponsor & Location

PENTA Foundation

Timeline & Enrollment

Phase 1/2

Jun 01, 2024

Jun 01, 2026

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 infections
HIV disease resulting in other bacterial infections
HIV disease resulting in multiple infections
Acute HIV infection syndrome
HIV disease resulting in other infectious and parasitic diseases

Data Source

ClinicalTrials.gov

NCT06139796

Non-Device Trial