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