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 (PENTA 18). - KONCERT

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 173

Inclusion Criteria

• Aged <18 years (up to 18th birthday) with confirmed HIV-1 infection
• Weight =15 kg
• Able to swallow 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 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 173
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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