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).

Phase 3

Completed

• Conditions: HIV infection; 10047438

• Registration Number: NL-OMON34553
• Lead Sponsor: PENTA Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

inclusiecriteria:
* Aged <18 years (up to 18th birthday) with confirmed HIV1
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 twicedaily 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 twicedaily and change the lopinavir/ritonavir dose to follow the recommended FDA dosing plan based on body weight bands as necessary
* Viral suppression (HIV1 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 the first 16 children enrolled in each body weight band in the trial, including a second PK assessment if randomised to switch to oncedaily lopinavir/ritonavir.
* Parents/carers and children, where applicable, give informed written consent;* a minimum of the first 16 children per weight band will be entered into the PK study and must be willing to change to taking halfstrength 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 the PK study has full evaluable PK data evaluable PK data has been obtained on 16 children in each weight band on twicedaily dosing and 8 in each weight band on oncedaily dosing, it will no longer be necessary for children entering the trial to be willing to take half strength formulation lopinavir/ritonavir tablets only

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified