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

Phase 1

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

• Registration Number: EUCTR2009-013648-35-FR
• Lead Sponsor: Paediatric European Network for Treatment of AIDS (PENTA) Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-29
• Study Completion: 2013-08-08
• Last Update Posted: 13 December 2021

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
•viral suppression (HIV-1 RNA <50 copies/mLl) 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 the first 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

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, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified