HIV infection
Conditions
Interventions
3 additional visits are required for the trial above the normal 3-monthly
clinic visit schedule
(screening, week 4 and week 8). This may involve children taking extra time out
of school
and parents
Sponsors
PENTA Foundation
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: inclusiecriteria: * Aged
Exclusion criteria
Exclusion criteria: Exclusion criteria * children on an antiretroviral regimen that includes a NNRTI, fosamprenavir or nelfinavir * children who have previously failed virologically on a PI containing regimen (where virological failure is defined as two successive HIV-1 RNA results>1000 copies/ml (confirmed) more than 24 weeks after starting HAART, i.e changes for toxicity are not counted as failure)* acute illness * abnormal renal or liver function (grade 3 or above) * receiving concomitant therapy except for prophylaxis; Some treatments may be allowed, but must first be discussed with a trial medical expert * pregnancy or risk of pregnancy in females of child bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In order to compare the proportion of children ever recording plasma RNA *50 copies/ml (confirmed within 4 weeks) on QD compared to BID therapy over 48 weeks, HIV-1 viral load will be measured at screening, week 0 and at all follow-up protocol visits. If at any time the HIV-1 viral load is >50 copies/ml, the family should be contacted so the HIV-1 viral load can be remeasured as soon as possible and within 4 weeks after the raised value. Samples will be taken and stored for confirmatory HIV-1 viral load testing in a centralised laboratory at the end of the trial. In order to evaluate the pharmacokinetics of twice-daily lopinavir/ritonavir half strength formulation tablets based on body weight a minimum of the first 16 children in each weight band (P15 to Q25kg, >25 to Q35kg, >35kg) will have an intensive PK day while on BID half strength formulation (day 0). Plasma concentrations of lopinavir and ritonavir will be determined by a validated high performance liquid chromatography assay with UV detection in a central laboratory (Radboud University Nijmegen). To compare the pharmacokinetics of twice-daily lopinavir/ritonavir tablets with once-daily dosing in the same children, children who have undergone an intensive PK day and have been subsequently randomised to QD dosing will have a second intensive PK day four weeks after starting QD dosing of lopinavir/ritonavir tablets. | — |
Secondary
| Measure | Time frame |
|---|---|
| The stage of children*s HIV disease by CDC classification (Appendix 8) will be recorded at entry to the trial and at each protocol visit, disease progression will be recorded on the follow-up CRF as well as any adverse events. Efficacy of twice- and once-daily dosing of lopinavir/ritonavir tablets will also be compared through analysis of HIV-1 viral load and T cell subsets measured locally at each protocol visit, and the presence of HIV mutations conferring resistance to drugs taken at randomisation or during the trial. | — |
Countries
Netherlands
Outcome results
None listed