The main purpose of this study is to measure the amount of lopinavir/ritonavir (two anti-HIV medications) in the blood. Results from this study will be compared to the levels of the drugs that have been found in other studies that showed that these medications were safe and effective.
This is a Phase II/III trial to assess the short-term pharmacokinetics, safety, and tolerance of LPV/r in HIV-infected infants and children initiating LPV/r therapy who weigh >3 and <25 kg and are dosed according to the WHO antiretroviral (ARV) weight band dosing guidelines. LPV/r will be administered as the heat-stable pediatric LPV/r 100/25 mg tablet in children who can swallow tablets or the liquid 80/20 mg/mL formulation in children who cannot swallow tablets. LPV/r will be dosed according to the WHO ARV weight band dosing schedule as part of a combination ARV regimen including two NRTIs as background therapy. The NRTI background will be prescribed by the health care provider according to local national and/or international guidelines for treatment of HIV-infected children. LPV/r will be provided as part of the study. The study duration, on treatment, will be 24 weeks.
|Clinical Study Identifier||NCT01338038|
|Sponsor||International Maternal Pediatric Adolescent AIDS Clinical Trials Group|
|Last Modified on||8 November 2020|
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