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

Completed

Conditions: Paediatric HIV
Infections and Infestations
Human immunodeficiency virus (HIV)

Registration Number: ISRCTN33191903

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 166

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

Grade 3 or 4 creatinine or liver function tests

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>2. Toxicity and tolerability of HAART<br>3. Adherence to HAART as assessed by caregiver completed questionnaire and CORALs<br>4. Progression to new AIDS defining event or death<br>5. Number of switches in antiretroviral therapy<br>6. The development of new genotypic resistance mutations by 96 weeks<br>7. Change in CD4% and CD4 count from baseline to week 96<br>8. Number of children in the target area for pharmacokinetic parameters after 12 weeks<br>9. Number of dosage adjustments based on pharmacokinetic parameters after 48 weeks