Paediatric HIV Infections and Infestations Human immunodeficiency virus (HIV)
Conditions
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.
Chil
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Brazil, Germany, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed