Tuberculosis Clinical Trial
Official title:
A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir (1:1) in the Presence of Rifampicin and Lopinavir/Ritonavir (4:1) Without Rifampicin in HIV and TB Co-infected Children in South Africa.
The purpose of this study is to determine the lopinavir levels in blood of HIV and TB infected children (3-15kg) when given lopinavir/ritonavir in a 1:1 ratio with rifampicin containing TB regimen and its safety.
This is a multicentre, open label, non-randomized, prospective, noninferiority study to
compare the pharmacokinetics of lopinavir administered with superboosting (LPV/r 1:1) and
concurrent RIF treatment or with standard boosting (LPV/r 4:1) without concurrent RIF
treatment, and to assess the safety, tolerance, and virological effect of superboosting in
HIV-TB co-infected infants and children weighing >3 kg and ≤15 kg.
LPV/r will be administered as the liquid 80/20 mg/mL formulation (4:1 standard boosting
ratio). During anti-TB treatment, additional RTV liquid formulation will be provided to
deliver a 1:1 superboosting ratio of LPV to RTV. Actual doses for antiretrovirals and
anti-TB drugs will be based on the South African (SA) weight band dosing recommendations and
provided as per the site standard of care.
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