Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR2008060000852767 Date of Approval: 20/04/2009
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Double dose Kaletra in children
Official scientific title Doubling The Dose Of Lopinavir/Ritonavir As An Approach To Using Kaletra® In TB/HIV-infected Patients Receiving Rifampicin-based TB Treatment
Brief summary describing the background and objectives of the trial Comparing Lopinavir concentrations in HIV-infected children with or without TB
Type of trial CCT
Acronym (If the trial has an acronym then please provide) PPK.DDK
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Tuberculosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2007
Actual trial start date
Anticipated date of last follow up 02/08/2008
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lopinavir (LPV)/Ritonavir (RTV) LPV: 460mg/m2/dose + RTV: 115mg/m2/dose for participants receiving rifampicin 6 months 93
Control Group Lopinavir (LPV)/Ritonavir (RTV) LPV: 230mg/m2/dose + RTV: 57.5mg/m2/dose for participants not receiving rifampicin 6 months 93 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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. Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/10/2006 University of Cape Town Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
E 52 ROOM 23 OLD MAIN BUILDING, Groote Schuur Hospital, OBSERVATORY, UNIVERSITY OF CAPE TOWN Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Efficacy Viral Load measurement six months after double dose Kaletra®
Primary Outcome Trough (pre-dose) LPV concentrations During and after TB treatment
Secondary Outcome Parmacokinetics of LPV and RTV in the study population During and after TB treatment
Secondary Outcome Safety ALT and adverse event assessments during co-treatment with HIV/TB drugs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Red Cross Childrens Hospital Klipfontein Road, Rondebosch CapeTown 7700 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership Francie van Zijl Drive, Parow valley Cape Town 7505 South Africa
South African Department of Health Room 300, Fedlife Building Cnr. Church and Prinsloo Street Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town Anzio Road, Observatory Cape Town 7925 South Africa University
Primary Sponsor University of Cape Town Anzio Road, Observatory Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr James Nuttall University of Cape Town, Anzio Road Observatory Cape Town 7925 South Africa
Dr James Nuttall University of Cape Town, Anzio Road Observatory Cape Town 7925 South Africa
Dr Brian Eley Red Cross Children's Hospital, Klipfontein Road, Rondebosch Cape Town 7700 South Africa
Dr Brian Eley Red Cross Children's Hospital, Klipfontein Road, Rondebosch Cape Town 7700 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Helen McIlleron Helen.McIlleron@uct.ac.za +27214066008 University of Cape Town. Division Clinical Pharmacology K45. Groote Schuur Hospital. Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa
Role Name Email Phone Street address
Public Enquiries Marque Venter marque.venter@uct.ac.za 0214066659 Groote Schuur Hospital, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Research Manager
Role Name Email Phone Street address
Scientific Enquiries Gary Maartens Gary.Maartens@uct.ac.za +27214066008 University of Cape Town. Division Clinical Pharmacology K45. Groote Schuur Hospital. Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Project Director
REPORTING
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Result URL Hyperlinks
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