Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children Receiving Concomitant Treatment With Kaletra

Phase 1 Unknown 40 enrolled Harriet Shezi Children's Clinic

RandomizedSingle-groupOpen-labelTreatment

Summary

Open label pharmacokinetic RBT dose-finding study in young (≤ 5 year old) HIV-infected children receiving a LPV/RTV-based ART regimen and who have a recent history of completing TB treatment.

Timeline

Start: 2010-11
Primary completion: 2011-06
Completion: 2012-06

Publications

Moultrie H, McIlleron H, Sawry S, Kellermann T, Wiesner L, Kindra G, Gous H, Van Rie A. Pharmacokinetics and safety of rifabutin in young HIV-infected children receiving rifabutin and lopinavir/ritonavir. J Antimicrob Chemother. 2015 Feb;70(2):543-9. doi: 10.1093/jac/dku382. Epub 2014 Oct 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rifabutin	Small molecule	5 mg/kg	Oral

Indications

No indication recorded.