PENTA8/ PERA (Paediatric Evaluation of Resistance Assays)

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN14367816
• Date of registration: 03/01/2001
• Prospective Registration: No
• Primary sponsor: Medical Research Council (MRC) (UK)
• Public title: PENTA8/ PERA (Paediatric Evaluation of Resistance Assays)
• Date of first enrolment: 01/06/2000
• Target sample size: 180
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14367816
• Study type: Interventional
• Study design: Randomised controlled trial (Not Specified)

Countries of recruitment

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

Contacts

• Name: Diana Gibb

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Paediatric HIV
Infections and Infestations
Human immunodeficiency virus (HIV)

Intervention(s)

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(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(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

Secondary ID(s)

E528/26

Source(s) of Monetary Support

Medical Research Council (UK)