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)
NCT ID: NCT01196195
Last Updated: 2013-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
173 participants
INTERVENTIONAL
2010-08-31
2013-08-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QD kaletra
Once daily kaletra
Kaletra dosed once daily
Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = once daily.
BID kaletra
twice daily dose of kaletra
kaletra dosed twice daily
Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = twice daily.
Interventions
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Kaletra dosed once daily
Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = once daily.
kaletra dosed twice daily
Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = twice daily.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
ANRS, Emerging Infectious Diseases
OTHER_GOV
PENTA Foundation
NETWORK
Responsible Party
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Locations
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Charite University Hospital Berlin
Berlin, , Germany
Department of Pediatric Oncology Hematology and Immunology KA02
Düsseldorf, , 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
Program for HIV Prevention and Treatment (PHPT)/IRD 174
Changklan, Muang, Chiang Mai, Thailand
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
Countries
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Related Links
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Related Info
Other Identifiers
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2009-013648-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KONCERT protocol, version 1.6
Identifier Type: -
Identifier Source: org_study_id