Condition category
Infections and Infestations
Date applied
03/01/2001
Date assigned
03/01/2001
Last edited
06/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Contact information

Type

Scientific

Primary contact

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

E528/26

Study information

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

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

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/06/2000

Overall trial end date

01/06/2005

Reason abandoned

Eligibility

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

Patient

Age group

Child

Gender

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

Locations

Countries of recruitment

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

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

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

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

1. Giaquinto C, Green H, De Rossi A, Saïdi Y, Compagnucci A, Girard S, Castelli-Gattinara G, della Negra M, Pinto J, De Souza Marques HH, Lyall EGH and Gibb DM on behalf of the PENTA 8 study group. A randomised trial of resistance testing versus no resistance testing in children with virological failure: the PERA (PENTA 8) trial. 3rd IAS Conference on HIV Pathogenesis and Treatment, 24-27 July 2005, Rio de Janerio. Oral and poster presentation WeOa0106 (.pdf file).
2. Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17302248

Publication citations

  1. Results

    Green H, Gibb DM, Compagnucci A, Giacomet V, de Rossi A, Harper L, Saïdi Y, Castelli-Gattinara G, Pillay D, Babiker AG, Aboulker JP, Lyall H, Bacheler LT, Walker AS, Debré M, Rosso R, Burger DM, Della Negra M, Dunn DT, Giaquinto C, , A randomized controlled trial of genotypic HIV drug resistance testing in HIV-1-infected children: the PERA (PENTA 8) trial., Antivir. Ther. (Lond.), 2006, 11, 7, 857-867.

Additional files

Editorial Notes