New HIV pill for kids pulled before start

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 120/20 mg DRV/r tablets * Willing to receive the 120/20 mg DRV/r 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: Cohort A: * Have 1 or 2 DRV resistance-associated mutations (RAMs)\* * Weigh 10 to \<25 kg at screening Cohort 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 it is 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 as described in the Summary of Product Characteristics (SmPC) * Concomitant medications that may interact with the current antiretroviral treatment, in particular TB drugs (i.e: rifampicin, rifabutin, rifapentine, …).