Therapeutic Drug Monitoring in HIV-Infected Children Starting a New Anti-Retroviral Regime.

An open, randomised, controlled trial in HIV-1 infected children starting or switching to a new antiretroviral therapy (ART) regimen. Findings to what level therapeutic drug monitoring is needed related to achieve full viral suppression and avoidance of resistence long term.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20993

Enrollment

166

Registered

2005-09-09

Start date

2004-10-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Children randomised to group 1 will receive “maximal TDM”. A full pharmacokinetic curve will be generated at week 4 (and repeated at 48 weeks) involving observed dosing and a day admission with repeat

Eligibility

Inclusion criteria

Inclusion criteria: 1. Confirmed HIV-infected, i.e. positive plasma HIV-1 RNA or 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 ³ 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: a. Either 3 or more active drugs including a PI and/or NNRTI; b. Or 2 active drugs: a boosted PI and an NNRTI.

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 the viral load in terms of change from baseline (start or switch of therapy) 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 96 weeks; 8. Number of children in target area for pharmacokinetic parameters after 12 weeks.	—

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 96 weeks; 8. Number of children in target area for pharmacokinetic parameters after 12 weeks.

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Contacts

Public ContactDiana Gibb

Reader in Epidemiology/Hon Consultant Paediatrician HIV Division MRC Clinical Trials Unit 222 Euston Road

Di.Gibb@ctu.mrc.ac.uk+44 (0)20 76704709

Outcome results