Condition category
Infections and Infestations
Date applied
11/07/2003
Date assigned
25/02/2004
Last edited
10/02/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

http://www.pentatrials.org/trials.htm#penpact1

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@child.pedi.unipd.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PENTA 14

Study information

Scientific title

Acronym

PENTA 14

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/07/2004

Overall trial end date

01/11/2007

Reason abandoned

Recruitment problems which were caused mainly by TDM being accepted as routine practice.

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

166 (14 recruited as of September 2006)

Participant exclusion criteria

Grade 3 or 4 creatinine or liver function tests

Recruitment start date

01/07/2004

Recruitment end date

01/11/2007

Locations

Countries of recruitment

Germany, Italy, Netherlands, United Kingdom

Trial participating centre

Clinica Pediatrica
Padova
35128
Italy

Sponsor information

Organisation

The Paediatric European Network for the treatment of AIDS (PENTA - Chair Dr Carlo Giaquinto)

Sponsor details

Clinica Pediatrica
Università di Padova
Via Giustiniani 3
Padova
35128
Italy
+39 (0)49 821 3563
carlog@child.pedi.unipd.it

Sponsor type

Other

Website

http://www.pentatrials.org.uk

Funders

Funder type

Government

Funder name

European Union (EU) - grant (ref: QLK2-2000-00150)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes