Contact information
Type
Scientific
Primary contact
Dr Carlo Giaquinto
ORCID ID
Contact details
Clinica Pediatrica
Universita di Padova
Via Giustiniani 3
Padova
35128
Italy
+39 (0)49 821 3563
carlog@pediatria.unipd.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PENTA 15/Version 3.0
Study information
Scientific title
Acronym
PENTA 15
Study hypothesis
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
Trent Multi-centre Research Ethics Committee (MREC) on 01/02/2006 (submitted 02/11/2005).
Study design
A non-randomised, cross-over, open label pharmacokinetic multi-centre study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Sample patient information sheet can be found in the full protocol at: http://www.pentatrials.org/p15_3_web.pdf
Condition
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 names
Abacavir (ABC), Lamivudine (3TC)
Primary outcome measure
Area under curve (AUC), Cmin and Cmax values of ABC after once and twice daily dosing
Secondary outcome measures
1. AUC, Cmin and Cmax values of 3TC after once and twice daily dosing
2. Assessment of adherence and satisfaction with twice and once daily dosage regimens, using questionnaires
Overall trial start date
01/01/2006
Overall trial end date
01/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
18
Participant exclusion criteria
1. Intercurrent illnesses
2. Receiving concomitant therapy except prophylactic antibiotics
3. Abnormal renal or liver function (grade 3 or above)
Recruitment start date
01/01/2006
Recruitment end date
01/06/2008
Locations
Countries of recruitment
France, Germany, Italy, Spain, United Kingdom
Trial participating centre
Clinica Pediatrica
Padova
35128
Italy
Sponsor information
Organisation
PENTA Foundation (Italy)
Sponsor details
Clinica Pediatrica
Universita di Padova
Via Giustiniani 3
Padova
35128
Italy
+39 (0)49 821 3563
carlog@pediatria.unipd.it
Sponsor type
Charity
Website
Funders
Funder type
Government
Funder name
PENTA Foundation (Italy) (mainly funded by the European Commission)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
GlaxoSmithKline (USA)
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20516550
Publication citations
-
Results
Pharmacokinetic study of once-daily versus twice-daily abacavir and lamivudine in HIV type-1-infected children aged 3-<36 months., Antivir. Ther. (Lond.), 2010, 15, 3, 297-305, doi: 10.3851/IMP1532.