Therapeutic drug monitoring (TDM) in human immunodeficiency virus (HIV)-infected children starting a new anti-retroviral regime
| ISRCTN | ISRCTN33191903 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33191903 |
| Secondary identifying numbers | PENTA 14 |
- Submission date
- 11/07/2003
- Registration date
- 25/02/2004
- Last edited
- 10/02/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Carlo Giaquinto
Scientific
Scientific
Clinica Pediatrica
Universita di Padova
Via Giustiniani 3
Padova
35128
Italy
| Phone | +39 (0)49 821 3563 |
|---|---|
| carlog@child.pedi.unipd.it |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PENTA 14 |
| Study objectives | 1. To assess the effect of different levels of Therapeutic drug monitoring (TDM) compared with no TDM on plasma human immunodeficiency virus-1 ribonucleic acid (HIV-1 RNA) response in children starting or switching to a new highly active antiretroviral therapy (HAART) regimen including a protease inhibitor (PI) and/or non-nucleoside reverse transcriptase inhibitor (NNRTI) 2. To generate age-related population pharmacokinetic models for PIs and NNRTIs used in children 3. To describe the impact of a didactic adherence support tool for children taking HAART, which will be offered to centres participating in the trial |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Paediatric HIV |
| Intervention | Full five point annual pharmacokinetic (PK) curve versus single sample PK versus no intervention. All children will receive additional adherence support. |
| Intervention type | Other |
| Primary outcome measure | 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 | 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 |
| Overall study start date | 01/07/2004 |
| Completion date | 01/11/2007 |
| Reason abandoned (if study stopped) | Recruitment problems which were caused mainly by TDM being accepted as routine practice. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 166 (14 recruited as of September 2006) |
| Key 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) |
| Key exclusion criteria | Grade 3 or 4 creatinine or liver function tests |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- Germany
- Italy
- Netherlands
- United Kingdom
Study participating centre
Clinica Pediatrica
Padova
35128
Italy
35128
Italy
Sponsor information
The Paediatric European Network for the treatment of AIDS (PENTA - Chair Dr Carlo Giaquinto)
Other
Other
Clinica Pediatrica
Università di Padova
Via Giustiniani 3
Padova
35128
Italy
| Phone | +39 (0)49 821 3563 |
|---|---|
| carlog@child.pedi.unipd.it | |
| Website | http://www.pentatrials.org.uk |
"ROR" |
https://ror.org/03ash3475 |
Funders
Funder type
Government
European Union (EU) - grant (ref: QLK2-2000-00150)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
