KONCERTA Kaletra ONCE daily Randomised Trial of the pharmacokinetics, safety and efficacy of twicedaily versus oncedaily lopinavir/ritonavir tablets dosed by weight as part of combination antiretroviral therapy in HIV-1 infected children (PENTA 18) - KONCERT

• Conditions: Paediatric HIV-1 Infection; MedDRA version: 12.1Level: LLTClassification code 10068341Term: HIV-1 infection

• Registration Number: EUCTR2009-013648-35-PT
• Lead Sponsor: PENTA Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-17
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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 (see 7.2.2); 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 (see 7.2.1)
•viral suppression (HIV-1 RNA <50 copies/ml) for at least the prior 24 weeks (minimum of 2 measurements).
•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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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
Main Objective: To determine whether young people with chronic HIV infection taking lopinavir/ritonavir once daily as part of their antiHIV therapy maintain the same level of suppression of the virus as those taking their therapy twice daily.;Secondary Objective: - To compare the level of lopinavir in the blood when tablets are taken once or twice daily.<br>- To compare the levels of lopinavir in the blood when half strength tablets are taken accordingly to weight bands compared with existing data from studies on lopinavir soft gel capsules and oral solution.;Primary end point(s): HIV1 RNA =50 copies/ml (confirmed) at any of week 4, 8, 12, 24, 36 or 48.<br><br>For the PK sub study:<br>AUC, Cmin and Cmax values of lopinavir after twicedaily dosing compared to historical adult and paediatric data.<br>AUC, Cmin and Cmax values of lopinavir after oncedaily and twicedaily dosing (in the same children)