Double dose Kaletra in childre

Not Applicable

• Conditions: HIV/AIDS; Tuberculosis

• Registration Number: PACTR2008060000852767
• Lead Sponsor: niversity of Cape Town

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-08
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

HIV-infected children with and without TB (controls) aged 6 months to 15 years.

Children eligible for, or, established on protease inhibitor-
based HAART according to National Treatment Guidelines

Exclusion Criteria

ALT > 10X the upper limit of normal (grade 3 or 4).

Known renal, hepatic or chronic GIT disease.

Receiving drugs other than the study medication known to potently induce or inhibit CYP3A4 or alter the PK of LPV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trough (pre-dose) LPV concentrations

Secondary Outcome Measures

Name	Time	Method
Efficacy;Parmacokinetics of LPV and RTV in the study population;Safety