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
Secondary identifying numbers	PENTA 15/Version 3.0

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

Study website

Contact information

Dr Carlo Giaquinto
Scientific

Clinica Pediatrica
Universita di Padova
Via Giustiniani 3
Padova
35128
Italy

Phone	+39 (0)49 821 3563
Email	carlog@pediatria.unipd.it

Study information

Study design	A non-randomised, cross-over, open label pharmacokinetic multi-centre study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Sample patient information sheet can be found in the full protocol at: http://www.pentatrials.org/p15_3_web.pdf
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/01/2006
Completion date	01/06/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Upper age limit	36 Months
Sex	Both
Target number of participants	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

France
Germany
Italy
Spain
United Kingdom

Study participating centre

Clinica Pediatrica

Padova
35128
Italy

Sponsor information

PENTA Foundation (Italy)
Charity

Clinica Pediatrica
Universita di Padova
Via Giustiniani 3
Padova
35128
Italy

Phone	+39 (0)49 821 3563
Email	carlog@pediatria.unipd.it
Website	http://www.ctu.mrc.ac.uk/penta
"ROR"	https://ror.org/00d7mpc92

Funders

Funder type

Government

PENTA Foundation (Italy) (mainly funded by the European Commission)

No information available

GlaxoSmithKline (USA)
Government organisation / For-profit companies (industry)

Alternative name(s): GlaxoSmithKline plc., GSK plc., GSK
Location: United Kingdom

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2010		Yes	No