Therapeutic drug monitoring (TDM) in human immunodeficiency virus (HIV)-infected children starting a new anti-retroviral regime

The Paediatric European Network for the treatment of AIDS (PENTA - Chair Dr Carlo Giaquinto)0 sites166 target enrollmentFebruary 25, 2004

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: The Paediatric European Network for the treatment of AIDS (PENTA - Chair Dr Carlo Giaquinto)
Enrollment: 166
Status: Completed
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

February 25, 2004

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

The Paediatric European Network for the treatment of AIDS (PENTA - Chair Dr Carlo Giaquinto)

•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)