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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: www.pactr.org

Trial no.: PACTR201206000391313 Date registered: 2012/06/14
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 HIV/AIDS , Tuberculosis ,
Purpose of the trial Prevention
Anticipated trial start date 2012-06-21
Actual trial start date
Anticipated date of last follow up 2012-12-31
Actual date of last follow up
Anticipated target sample size (number of participants) 70   
Actual target sample size (number of participants)   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
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 Min age Max age Gender
Stable on ART: efavirenz, nevirapine or lopinavir/ritonavir Hepatitis Pregnant Using CYP450 inducers/inhibitors Excessive alchol use Intolerant to isoniazid 18 Years 100 Years 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 Fax
Principal Investigator Prof Gary Maartens gary.maartens@uct.ac.za 021 406 6286
Street address City Postal code Country Position / Affiliation
Observatory 7925 South Africa Division of Clinical Pharmacology
Role Name Email Phone Fax
Public Enquiries Dr Eric Decloedt eric.decloedt@uct.ac.za 021 406 6353
Street address City Postal code Country Position / Affiliation
Obeservatory 7925 South Africa Division of Clinical Pharmacology
Role Name Email Phone Fax
Scientific Enquiries Dr Eric Decloedt eric.decloedt@uct.ac.za 021 406 6353
Street address City Postal code Country Position / Affiliation
Observatory 7925 South Africa Division of Clinical Pharmacology