KONCERT: A Kaletra ONCE daily Randomised Trial of the pharmacokinetics, safety and efficacy of twice-daily versus once-daily lopinavir/ritonavir tablets dosed by weight as part of combination antiretroviral therapy in HIV-1 infected children.
Kaletra once daily vs twice daily.
What is this study about?
KONCERT is looking at a type of antiretroviral (anti-HIV) medicine called Kaletra that is currently used in children. The first aim of KONCERT is to find out whether taking Kaletra once-daily rather than twice-daily is safe and effective in children. It is very important to take antiretroviral medicines every day but it can be very difficult to give them to children several times per day. If medicines can be taken safely once-daily, this may make them easier to give.
The second aim of KONCERT is to get more information about the correct dose of Kaletra to give children. This is done by measuring the level of the medicine in the child’s blood. This information is needed because a new (smaller) Kaletra tablet for children has recently been approved in many countries and it is important to get as much information as possible about this new tablet.
Who is included?
When is it taking place?
Started recruitment in 2010.
Where is it taking place?
The trial recruits from hospital sites in Europe, South America, and Thailand.
Who is funding the study?
|Type of study:||Randomised trial|
|Status:||Closed to recruitment; in follow-up|
|Randomisation target:||160 children|
|Randomisations achieved:||173, as of 03 September 2012|
|Chief investigator:||Dr Hermione Lyall, St Mary’s Hospital, London.|
|Sponsor:||PENTA Foundation. MRC is co-sponsor for the UK. |
|Registration numbers:||EUDRACT: 2009-013648-35; ISRCTN02452400|
|Inclusion criteria:||• Aged <18 years (up to 18th birthday) with confirmed HIV-1 infection |
• Weight >/=15 kg
• Able to swollow tablets
• Stable (i.e. CD4 not declining) on a combination antiretroviral regimen that has included lopinavir/ritonavir for at least 24 weeks
• Taking lopinavir/ritonavir dosed twice-daily and be willing at the screening visit to change to tablet formulation (if not currently taking tablets) and to change the lopinavir/ritonavir dose to follow the recommended FDA dosing plan based on body weight bands as necessary; if participating in the PK study*, be willing at the screening visit to change to lopinavir/ritonavir half strength formulation tablets (100/25mg) only, dosed twice-daily and change the lopinavir/ritonavir dose to follow the recommended FDA dosing plan based on body weight bands as necessary
• Most recent HIV-1 RNA viral load <50 copies/ml, and viral suppression for the previous 24 weeks. Where viral suppression is defined as HIV-1 RNA <50 copies/ml, with the exception of a single measurement >/=50 but <400 copies/ml
• Children and caregivers willing to participate in the PK study if they are among a minimum of 16 children enrolled in each body weight band in the trial, including a second PK assessment if randomised to switch to once-daily lopinavir/ritonavir
• Parents/carers and children, where applicable, give informed written consent
*A minimum of 16 children per weight band will be entered into the PK study and must be willing to change to taking half-strength formulation lopinavir/ritonavir tablets (100/25mg) only, dosed according to the FDA recommended dosing plan based on their body weight, at the screening visit. Once it has been confirmed that evaluable PK data have been obtained for each weight band on twice- and once-daily dosing, it will no longer be necessary for children entering the trial to take half strength formulation lopinavir/ritonavir tablets only.
|Exclusion criteria:||• Children on an antiretroviral regimen that includes a NNRTI, fosamprenavir or nelfinavir|
• Children on an antiretroviral regimen that includes a NNRTI or any PI other than lopinavir/ritonavir
• 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
|Intervention and control groups:||Kaletra once daily vs twice daily.|
|Method of randomisation:||1:1|
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