Pharmacokinetics, safety and acceptability of a solid paediatric fixed-dose combination of darunavir/ritonavir (DRV/r) 120/20 mg for children living with HIV

Fondazione Penta ETS0 个研究点目标入组 50 人开始时间: 2024年3月21日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•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 DRV/r 120/20 mg tablets
•Willing to receive the DRV/r 120/20 mg 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:
•?Have 1 or 2 DRV resistance-associated mutations (RAMs)*
•?Weigh 10 to <25 kg at screening
•?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

•Presence of >2 darunavir RAMs*
•Failure of protease genotypic resistance testing at baseline, except if treatment history indicates that darunavir RAMs are 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
•Concomitant medications that may interact with the current antiretroviral treatment, in particular TB drugs (i.e: rifampicin, rifabutin, rifapentine, …).

发起方

Fondazione Penta ETS