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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 Human Immunodeficiency Virus-1 (HIV-1) Infected Children (PENTA 18)

Information source: PENTA Foundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Antiretroviral Therapy in HIV-1 Infected Children

Intervention: Kaletra dosed once daily (Drug); kaletra dosed twice daily (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: PENTA Foundation

Summary

The trial will evaluate the pharmacokinetics, safety, efficacy and acceptability of twice- and once-daily dosing of lopinavir/ritonavir tablets (Kaletra) dosed by weight in HIV-1 infected children who are currently taking lopinavir/ritonavir as part of their combination antiretroviral therapy and who are currently achieving virological suppression (<50 copies/ml). Specifically:

- To confirm weight-based dosing recommendations by evaluating the pharmacokinetics of

twice-daily lopinavir/ritonavir half strength formulation tablets dosed on body weight and comparing to historical adult and paediatric data of pharmacokinetics of lopinavir/ritonavir soft gel capsules and oral solution respectively (1, 2).

- To compare the pharmacokinetics of twice-daily lopinavir/ritonavir tablets with

once-daily dosing in the same children.

- To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to

twice-daily dosing in terms of virological suppression at 48 weeks. Adherence and acceptability will also be compared.

Clinical Details

Official title: 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 Human Immunodeficiency Virus-1 (HIV-1) Infected Children (PENTA 18)

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).

To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).

To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).

To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).

To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).

To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA ≥50 copies/ml (confirmed).

To compare the pharmacokinetics of twice-daily lopinavir/ritonavir tablets with once-daily dosing in the same children

Secondary outcome:

To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA <400/<50 copies/ml.

To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to twice-daily dosing in terms of virological suppression. This is measured by HIV-1 RNA <400/<50 copies/ml.

Acceptability and adherence to once-daily versus twice-daily dosing of lopinavir/ritonavir tablets

Eligibility

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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 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

Exclusion Criteria:

- children on an antiretroviral regimen that includes a non-nucleoside reverse

transcriptase inhibitor (NNRTI), fosamprenavir or nelfinavir

- children who have previously failed virologically on a protease inhibitor (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 highly active antiretroviral therapy (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

Locations and Contacts

Charite University Hospital Berlin, Berlin, Germany

Department of Pediatric Oncology Hematology and Immunology KA02, Dusseldorf, Germany

J W Goethe University, Frankfurt, Germany

Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital, Munich, Germany

Our Lady's Children's Hospital, Dublin, Ireland

Emma Childrens Hospital, Amsterdam, Netherlands

UMC St. Radboud, Nijmegen, Netherlands

HIV-NAT Thai Red Cross AIDS Research Centre, Bangkok, Thailand

Birmingham Heartlands Hospital, Birmingham, United Kingdom

University Hospital Bristol, Bristol, United Kingdom

Evelina Children's Hospital, London, United Kingdom

Great Ormond Street Hospital, London, United Kingdom

King's College Hospital, London, United Kingdom

St. Mary's Hospital, London, United Kingdom

Nottingham City Hospital Campus, Nottingham, United Kingdom

John Radcliffe Hospital, Oxford, United Kingdom

Program for HIV Prevention and Treatment (PHPT)/IRD 174, Changklan, Muang, Chiang Mai 50100, Thailand

Additional Information

Starting date: August 2010
Last updated: October 25, 2013

Page last updated: August 23, 2015

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