PENTA 18 version 1.0

• Research type

  Research Study

• Full 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 HIV-1 infected children (PENTA 18).

• IRAS ID

  26635

• Contact name

  E G Hermione Lyall

• Sponsor organisation

  PENTA Foundation

• Eudract number

  2009-013648-35

• ISRCTN Number

  02452400

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  In current practice for children and young people with HIV-1 infection, lopinavir/ritonavir tablets are prescribed twice daily. Due to the burden of taking medications on the children and their families there is significant scope to explore if once daily dosing has the same benefits as twice daily dosing and at the same time is as safe as twice daily dosing. Studies in adults suggest that once-daily lopinavir/ritonavir is comparable to twice-daily dosing. Therefore this trial will evaluate twice- and once-daily dosing of lopinavir/ritonavir tablets (Kaletra) in terms of the level of drug in blood, safety, efficacy and acceptability.Evaluating the current dosing guidelines in children and young people taking the licensed half-strength paediatric tablets will provide evidence that the recommended lopinavir/ritonavir dose provides adequate drug exposure and maintains efficacy. Furthermore, decreasing the frequency with which medication needs to be taken in a day is likely to increase convenience and to enhance adherence to antiretroviral therapy in HIV-1 infected children.PENTA 18 is a prospective, open label, multicentre, randomised (1:1) phase II/III trial. Children who are currently taking lopinavir/ritonavir as part of their combination antiretroviral therapy and who are currently achieving virological suppression (<50 copies/ml). will be randomised 1:1 into two groups:1. Twice-daily lopinavir/ritonavir (BID arm)2. Once-daily lopinavir/ritonavir (QD arm)Randomisation will be stratified by body weight band (=15 to = 25kg, >25 to = 35kg, >35kg). 160 HIV-1 infected children aged <18 years will be followed for a minimum 48 weeks. All children will be seen for clinic visits at weeks -4 (screening), 0, 4, 8, 12, 24, 36 and 48.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  09/H0405/49

• Date of REC Opinion

  12 Jan 2010

• REC opinion

  Further Information Favourable Opinion