Condition category
Infections and Infestations
Date applied
07/12/2005
Date assigned
17/01/2006
Last edited
14/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.ctu.mrc.ac.uk/penta

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20516550

Publication citations

  1. 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.

Additional files

Editorial Notes