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PENTA8/ PERA (Paediatric Evaluation of Resistance Assays)
ISRCTN ISRCTN14367816
DOI 10.1186/ISRCTN14367816
ClinicalTrials.gov identifier
EudraCT number
Public title PENTA8/ PERA (Paediatric Evaluation of Resistance Assays)
Scientific title
Acronym PERA
Serial number at source E528/26
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
Lay summary
Ethics approval Not provided at time of registration.
Study design Randomised controlled trial
Countries of recruitment Brazil, Germany, Italy, Portugal, Spain, United Kingdom
Disease/condition/study domain Paediatric HIV
Participants - 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
Participants - 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
Anticipated start date 01/06/2000
Anticipated end date 01/06/2005
Status of trial Completed
Patient information material
Target number of participants 180, 170 recruited as of Sept 2006
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding Medical Research Council (UK)
Trial website http://www.pentatrials.org/trials.htm#penpact1
Publications 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
Contact name Prof  Diana  Gibb
  Address MRC Clinical Trials Unit
222 Euston Road
  City/town London
  Zip/Postcode NW1 2DA
  Country United Kingdom
  Tel +44 (0)20 7670 4709
  Fax +44 (0)20 7670 4818
  Email d.gibb@ctu.mrc.ac.uk
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email clinical.trial@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 03/01/2001
Last edited 06/08/2008
Date ISRCTN assigned 03/01/2001
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