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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR2008060000852767 |
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Date of registration:
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08/02/2008 |
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Primary sponsor: |
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Public title:
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Double dose Kaletra in children
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Scientific title:
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Doubling The Dose Of Lopinavir/Ritonavir As An Approach To Using Kaletra? In TB/HIV-infected Patients Receiving Rifampicin-based TB Treatment |
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Date of first enrolment:
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Target sample size:
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Recruitment status: |
Terminated |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2008060000852767 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Non-randomised,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Marque
Venter |
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Address:
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Groote Schuur Hospital, Observatory
7925
Cape Town
South Africa |
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Telephone:
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0214066659 |
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Email:
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marque.venter@uct.ac.za |
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Affiliation:
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Research Manager |
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Name:
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Gary
Maartens |
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Address:
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University of Cape Town. Division Clinical Pharmacology K45. Groote Schuur Hospital. Observatory
7925
Cape Town
South Africa |
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Telephone:
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+27214066008 |
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Email:
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Gary.Maartens@uct.ac.za |
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Affiliation:
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Project Director |
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Key inclusion & exclusion criteria
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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 b 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.
Age minimum:
1 null
Age maximum:
15 null
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
Tuberculosis
null
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Primary Outcome(s)
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Trough (pre-dose) LPV concentrations
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Secondary Outcome(s)
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Efficacy
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Parmacokinetics of LPV and RTV in the study population
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Safety
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Source(s) of Monetary Support
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European and Developing Countries Clinical Trials Partnership
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South African Department of Health
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