HIV/AIDS Paediatrics
Conditions
Sponsors
Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) HIV infected infants aged 3 months to <12 months currently taking or about to start LPV/r syrup based first-line following WHO guidelines 2008 [7]. OR HIV infected children able to swallow paediatric LPV/r tablets and aged 4-13 years and <25Kg, currently taking or about to start LPV/r based second-line following WHO guidelines. OR HIV infected infants aged 1 to 4 years currently taking or about to start LPV/r syrup based first-line 2. Carers, and children where appropriate, willing and able to give informed consent
Exclusion criteria
Exclusion criteria: Children: 1. Who are expected to change weight bands (i.e. change dose) after enrolment and before PK day at week 8 2. With anaemia (haemoglobin <8.5g/dL), or liver enzymes grade 2 or higher. 3. With illnesses that could influence the pharmacokinetics of the antiretroviral (ARV) drugs at week 4 and week 8 e.g. severe diarrhoea, vomiting, renal or liver disease 4. On concomitant medications that are known to interact with the ARV drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the pharmacokinetics of ritonavir-boosted-lopinavir (LPV/r) in twice daily paediatric co-formulated fixed dose sprinkle combination (lopimune);To determine the pharmacokinetics of ritonavir-boosted-lopinavir (LPV/r) in twice daily paediatric co-formulated fixed dose sprinkle combination (lopimune);To determine the pharmacokinetics of ritonavir-boosted-lopinavir (LPV/r) in twice daily paediatric co-formulated fixed dose sprinkle combination (lopimune);To determine the pharmacokinetics of ritonavir-boosted-lopinavir (LPV/r) in twice daily paediatric co-formulated fixed dose sprinkle combination (lopimune) | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare formulation preferences of children and their carers ;Compare formulation preferences of infants' carers;Evaluate the effects of age, sex, severity of illness and anthropometric measurements on PK parameters for LPV/r | — |
Countries
Uganda
Contacts
Public ContactNatalie;Bethany Young;Naidoo
Data Manager;Clinical Trial Manager
Outcome results
None listed