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PACTR201302000426554

Pharmacokinetics of lopinavir/ritonavir superboosting in infants and young children co-infected with HIV and TB

An open label, sequential non-randomised pharmacokinetics study comparing lopinavir plasma exposure when given as lopinavir superboosted with ritonavir (1:1 ratio) in the presence of rifampicin or lopinavir boosted with ritonavir (4:1 ratio) in the absence of rifampicin in HIV and TB co-infected children in South Africa
Drugs for Neglected Diseases Initiative·Not Applicable·Pan Africa Clinical Trials Registry·otherRecruiting
Study focus
Disease/Condition
Infections and Infestations; Infections and Infestations
Intervention type
other
Sponsor & location
Primary sponsor
Drugs for Neglected Diseases Initiative
Funder
Médecins Sans Frontières - Norway; UBS Foundation
Location
South Africa
Timeline & enrollment
Phase
Not Applicable
Start date
Jan 31, 2013
End date
Jan 01, 1900
Summary

Currently available data describing the pharmacokinetics, safety and efficacy of superboosted LPV/r is limited to 15 children mostly between 1 and 2 years of age. Subsequently doses of rifampicin and other anti-TB drugs have been increased. More data is needed to support superboosting in children of various ages and clinical conditions using the new rifampicin doses.The proposed study will evaluate the pharmacokinetics of LPV/r 1:1 with rifampicin in young children weighing 3-15kg based on South African treatment guidelines. It will serve as a benchmark for future evaluation of the solid, dispersible, child friendly formulation of RTV to be used as a booster, which DNDi is currently developing.

ICD-10 classifications
Certain infectious and parasitic diseasesInfestation, unspecifiedOther specified infestationsOther infestationsSequelae of infectious and parasitic diseases
Data source
Registry
Pan Africa Clinical Trials Registry
Trial ID
PACTR201302000426554
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for PACTR201302000426554 through Pure Global AI's free database. This Not Applicable trial is sponsored by Drugs for Neglected Diseases Initiative and is currently Recruiting. The study focuses on Infections and Infestations; Infections and Infestations.

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