PENTA8/ PERA (Paediatric Evaluation of Resistance Assays)

Plain English Summary

Not provided at time of registration

Study website

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

Type

Scientific

Contact name

Prof Diana Gibb

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
+44 (0)20 7670 4709
d.gibb@ctu.mrc.ac.uk

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

E528/26

Scientific title

Acronym

PERA

Study hypothesis

To evaluate whether the use of resistance testing using a centralised genotypic assay with computer assisted interpretation (VIRCO 'virtual phenotype') to make decisions about a new regimen results in a greater reduction in human immunodeficiency virus (HIV)-1 RNA in HIV infected children than choice based on drug history and clinical factors alone

Ethics approval(s)

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Not specified

Study type

Not Specified

Patient information sheet

Condition

Paediatric HIV

Intervention

Children randomised to Arm 1 will have access to a centralised genotypic assay, with computer assisted interpretation based on a database of linked results from genotypic and phenotypic testing.

Children randomised to Arm 2 will receive no resistance testing.

Intervention type

Other

Primary outcome measure

The primary end-point is plasma HIV-1 RNA at 12 months measured in the central laboratory using the Roche ultra-sensitive assay (limit of detection 50 copies/ml)

Secondary outcome measures

1. Plasma HIV-1 RNA at 24 weeks
2. CD4 count adjusted for age at 12 months, measured locally
3. Antiretroviral therapy (ART) prescribed, in particular the number of switches in ART and drugs used
4. Adherence to ART prescribed (as measured by questionnaire)
5. Available drug options at 12 months
6. Progression to new acquired immunodeficiency syndrome (AIDS) defining event or death
7. Tolerability of, and adverse events to ART in the two arms
8. Proportion of children with viral load <50 copies/ml at 12 months

Overall study start date

01/06/2000

Overall study end date

01/06/2005

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Confirmed HIV-infected
2. Age 3 months to 18 years
3. Currently receiving and stable on the same antiretroviral therapy for at least 1 month; OR, if not on therapy, stopped within the last 2 weeks
4. Parents/guardians, and children where appropriate, are willing and able to give informed consent
5. Previous exposure to two or three classes of antiretroviral drugs, or, if exposed to nucleoside analogue reverse transcriptase inhibitors (NRTI) only, either exposed to three NRTI or two NRTI for more than 2 years
6. The paediatrician is likely to change treatment
7. Most recent HIV RNA result was >2000 copies/ml
8. Paediatrician and parents are willing to wait 3 weeks for the resistance assay result before switching therapy
9. Local resistance testing will not be done during the trial

Participant type(s)

Patient

Age group

Child

Lower age limit

3 Months

Upper age limit

18 Years

Sex

Both

Target number of participants

180, 170 recruited as of Sept 2006

Participant exclusion criteria

1. A previous resistance test, assessing both reverse transcriptase and protease inhibitor drug resistance has been performed while the child is on the current regimen. Children who have had a test on a previous regimen may be enrolled to a maximum recruitment of 30 children.
2. Unlikely to comply with the routine schedule of visits

Recruitment start date

01/06/2000

Recruitment end date

01/06/2005

Countries of recruitment

Brazil, England, Germany, Italy, Portugal, Spain, United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

UK Medical Research Council, MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs