Status:
COMPLETED
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)
Lead Sponsor:
PENTA Foundation
Collaborating Sponsors:
Medical Research Council
ANRS, Emerging Infectious Diseases
Conditions:
Antiretroviral Therapy in HIV-1 Infected Children
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT01196195
Start Date
August 1 2010
End Date
August 1 2013
Last Update
October 28 2013
Active Locations (17)
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1
Charite University Hospital Berlin
Berlin, Germany
2
Department of Pediatric Oncology Hematology and Immunology KA02
Düsseldorf, Germany
3
J W Goethe University
Frankfurt, Germany
4
Immundefekt-Ambulanz, Dr. von Haunersches Kinderspital
Munich, Germany