PENTA18: A study 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

The PENTA Foundation (Italy)0 个研究点目标入组 160 人开始时间: 2009年7月10日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Aged less than 18 years (up to 18th birthday) with confirmed HIV-1 infection, either sex
•2. Weight greater than or equal to 15 kg
•3. Able to swallow tablets
•4. Stable (i.e. CD4 not declining) on a combination antiretroviral regimen that has included lopinavir/ritonavir for at least 24 weeks, and expected to stay on the same regimen for the next 48 weeks
•5. 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; if participating in the PK study, be willing at the screening visit to change to lopinavir/ritonavir half strength formulation tablets (100/25 mg) only, dosed twice-daily and change the lopinavir/ritonavir dose to follow the recommended FDA dosing plan based on body weight bands as necessary
•6. Viral suppression (HIV-1 ribonucleic acid [RNA] less than 50 copies/ml) for at least the prior 24 weeks (minimum of two measurements)
•7. 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
•8. Parents/carers and children, where applicable, give informed written consent

•1. Children on an antiretroviral regimen that includes a non-nucleoside reverse transcriptase inhibitor (NNRTI), fosamprenavir or nelfinavir
•2. Children who have previously failed virologically on a protease inhibitor (PI)-containing regimen (where virological failure is defined as two successive HIV-1 ribonucleic acid [RNA] results greater than 1000 copies/ml [confirmed] more than 24 weeks after starting highly active anti-retroviral therapy [HAART], i.e changes for toxicity are not counted as failure)
•3. Intercurrent illness
•4. Abnormal renal or liver function (grade 3 or above)
•5. Receiving concomitant therapy except prophylactic antibiotics
•6. Pregnancy or risk of pregnancy in females of child-bearing potential

发起方

The PENTA Foundation (Italy)