Paediatric HIV Infections and Infestations Human immunodeficiency virus (HIV)
Conditions
Interventions
Full five point annual pharmacokinetic (PK) curve versus single sample PK versus no intervention. All children will receive additional adherence support.
Sponsors
The Paediatric European Network for the treatment of AIDS (PENTA - Chair Dr Carlo Giaquinto)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed HIV-infected, i.e. positive plasma HIV-1 RNA or deoxyribonucleic acid (DNA) test on two consecutive occasions (for children less than 18 months old), or positive HIV serology (for children aged 18 months and older), aged one month to 17 years inclusive 2. Parents/guardians, and children where appropriate, are willing and able to give informed consent 3. Plasma HIV-1 RNA viral load = 1000 copies/ml 4. Pre-treated children, including children who have received antiretroviral therapy only as prophylaxis to reduce mother to child transmission, who are prepared to wait for the results of a resistance test before starting new therapy 5. Starting antiretroviral therapy or switching to a new antiretroviral regimen considered likely to be highly active according to the results of a local resistance test, and containing either a PI or NNRTI or both; that is with at least two active drugs, one being a PI or NNRTI (active means not fully resistant)
Exclusion criteria
Exclusion criteria: Grade 3 or 4 creatinine or liver function tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of the TDM strategies on viral load in terms of change in plasma HIV-1 RNA copies/ml from baseline to 96 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of children who ever achieve plasma HIV-1 RNA <50 copies/ml, and who subsequently maintain plasma HIV-1 RNA <50 copies/ml to 96 weeks 2. Toxicity and tolerability of HAART 3. Adherence to HAART as assessed by caregiver completed questionnaire and CORALs 4. Progression to new AIDS defining event or death 5. Number of switches in antiretroviral therapy 6. The development of new genotypic resistance mutations by 96 weeks 7. Change in CD4% and CD4 count from baseline to week 96 8. Number of children in the target area for pharmacokinetic parameters after 12 weeks 9. Number of dosage adjustments based on pharmacokinetic parameters after 48 weeks | — |
Countries
Germany, Italy, Netherlands, United Kingdom
Outcome results
None listed