IVERSAL2: Pharmacokinetics safety and acceptability of DRV/r for children living with HIV

Phase 2

Not yet recruiting

• Conditions: HIV/AIDS

• Registration Number: PACTR202405769820746
• Lead Sponsor: Fondazione Penta ETS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-21
• Last Update Posted: 2024-05-27

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•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:
oCohort A:
?Have 1 or 2 DRV resistance-associated mutations (RAMs)*
?Weigh 10 to <25 kg at screening
oCohort B:
?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

Exclusion Criteria

•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, …).

Study & Design

• Study Type: Interventional
• Study Design: Not specified