Plasma pharmacokinetic study of once versus twice daily abacavir as part of combination antiretroviral therapy in children with human immunodeficiency virus-1 infection aged 3 months to less than 36 months
| ISRCTN | ISRCTN38147516 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38147516 |
| Protocol serial number | PENTA 15/Version 3.0 |
| Sponsor | PENTA Foundation (Italy) |
| Funders | PENTA Foundation (Italy) (mainly funded by the European Commission), GlaxoSmithKline (USA) |
- Submission date
- 07/12/2005
- Registration date
- 17/01/2006
- Last edited
- 14/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=26
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@pediatria.unipd.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A non-randomised, cross-over, open label pharmacokinetic multi-centre study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | PENTA 15 |
| Study objectives | Aim is to assess the pharmacokinetics, feasibility and acceptability of dosing abacavir (ABC) or ABC in combination with lamivudine (3TC) once daily in children aged 3 to less than 36 months. Please note that the previous anticipated end date of this trial was 01/05/2007; the information held in this record was updated on the 17/09/2007 (from version 1.0 to version 3.0) at the request of the PI. The changes made for this version update included the above mentioned change to the anticipated end date, the addition of ethics approval, and a change to the countries of recruitment (which previously included Austria, Brazil, Germany, Ireland, Italy, Netherlands, Poland, Sweden, Thailand, United Kingdom, Argentina, Belgium, Denmark, France, Portugal, Romania, Spain, Switzerland). |
| Ethics approval(s) | Trent Multi-centre Research Ethics Committee (MREC) on 01/02/2006 (submitted 02/11/2005). |
| Health condition(s) or problem(s) studied | Paediatric HIV |
| Intervention | 1. At week 0, while children enrolled in the study are on a twice-daily regimen containing ABC or ABC and 3TC, serial pharmacokinetic samples will be collected 2. Following collection of these samples, children will cross over and begin a regimen of ABC 16 mg/kg once-daily (and 3TC 8 mg/kg once-daily if applicable) for at least 12 weeks, with the second pharmacokinetic sample collected at week 4 3. The same daily dose will be maintained within 25% (allowing for dose adjustment for growth as appropriate) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Abacavir (ABC), Lamivudine (3TC) |
| Primary outcome measure(s) |
Area under curve (AUC), Cmin and Cmax values of ABC after once and twice daily dosing |
| Key secondary outcome measure(s) |
1. AUC, Cmin and Cmax values of 3TC after once and twice daily dosing |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 36 Months |
| Sex | All |
| Target sample size at registration | 18 |
| Key inclusion criteria | 1. Infants and children with confirmed presence of human immunodeficiency virus (HIV-1) infection 2. Infants and children aged 3 to less than 36 months 3. Parents able/willing to give consent 4. Currently on combination anti-retroviral therapy (ART) including ABC oral solution or a combination of ABC and 3TC, for at least 12 weeks, and expected to stay on this regimen for at least a further 12 weeks 5. HIV-1 ribonucleic acid (RNA) viral load - either suppressed HIV-1 RNA viral load (i.e. less than 400 copies/ml) or non-suppressed but low HIV-1 RNA viral load (i.e. 400 - 20,000 copies/ml). The non-suppressed children should have had a stable or decreasing HIV-1 RNA viral load prior to study entry and should be considered to still be gaining benefit from the current regimen. 6. Children should have stable or rising cluster of differentiation-4 (CD4+) cell percentage prior to study entry and their CD4+ cell percentage should not be expected to fall within the next 12 weeks |
| Key exclusion criteria | 1. Intercurrent illnesses 2. Receiving concomitant therapy except prophylactic antibiotics 3. Abnormal renal or liver function (grade 3 or above) |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- United Kingdom
- France
- Germany
- Italy
- Spain
Study participating centre
Clinica Pediatrica
Padova
35128
Italy
35128
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
