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.: PACTR201206000391313 Date of Registration: 14/06/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The pharmacokinetics of lopinavir/ritonavir, nevirapine and efavirenz when given with isoniazid in South African HIV-infected individuals
Official scientific title The pharmacokinetics of lopinavir/ritonavir, nevirapine and efavirenz when given with isoniazid in South African HIV-infected individuals
Brief summary describing the background and objectives of the trial INH has been shown to inhibit various cytochrome P450 (CYP) isoforms including CYP3A4.IPT and ART have complementary roles for tuberculosis prevention and is likely to be a priority intervention as part of of HIV treatment. We propose to study the pharmacokinetics of INH when administered with ART, specifically NVP, EFV and LPV/r.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) APK.IPT
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 Prevention
Anticipated trial start date 21/06/2012
Actual trial start date
Anticipated date of last follow up 31/12/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL http://www.ncbi.nlm.nih.gov/pubmed/23407222#
Secondary Ids Issuing authority/Trial register
MCC no N2/19/8/2 (0838)
HREC no 047/2011
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
Crossover: all participants receive all interventions in different sequence 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 Isoniazid 5mg/kg/day, max 300mg/day 7 days PK sampling on day one, day two start INH for one week, day seven PK sampling again 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Stable on ART: efavirenz, nevirapine or lopinavir/ritonavir Hepatitis Pregnant Using CYP450 inducers/inhibitors Excessive alchol use Intolerant to isoniazid 18 Year(s) 100 Year(s) 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 University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Anzio Road Observatory 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pharmacokinetics of lopinavir With and without isoniazid
Secondary Outcome Safety Continous
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Division of Clinical Pharmacology Hospital road Observatory 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Cape Town University
COLLABORATORS
Name Street address City Postal code Country
Jan-Stefan van der Walt Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gary Maartens gary.maartens@uct.ac.za 021 406 6286
City Postal code Country Position/Affiliation
Observatory 7925 South Africa Division of Clinical Pharmacology
Role Name Email Phone Street address
Public Enquiries Eric Decloedt eric.decloedt@uct.ac.za 021 406 6353
City Postal code Country Position/Affiliation
Obeservatory 7925 South Africa Division of Clinical Pharmacology
Role Name Email Phone Street address
Scientific Enquiries Eric Decloedt eric.decloedt@uct.ac.za 021 406 6353
City Postal code Country Position/Affiliation
Observatory 7925 South Africa Division of Clinical Pharmacology
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information