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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.: PACTR201206000159453 Date registered: 2009/08/14
TRIAL DESCRIPTION
Public title The pharmacokinetics of lopinavir in South African HIV-infected volunteers receiving rifampicin with adjusted doses of LOPINAVIR/ritonavir.
Official scientific title The pharmacokinetics of lopinavir in South African HIV-infected volunteers receiving rifampicin with adjusted doses of LOPINAVIR/ritonavir.
Brief summary describing the background
and objectives of the trial
There is an urgent need to investigate practical approaches to using antiretrovirals together with tuberculosis (TB) treatment. We propose to study the pharmacokinetics of LPV in 24 HIV-infected adult volunteers established on an antiretroviral regimen comprising LPV/RTV plus 2 NRTIs at steady state and in combination with rifampicin.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) APK.DDK
Disease(s) or condition(s) being studied HIV/AIDS , Tuberculosis ,
Purpose of the trial Treatment
Anticipated trial start date
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up
Anticipated target sample size (number of participants)   
Actual target sample size (number of participants) 24   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
UCT REC 422/2007 & N2/19/8/2(2262)(2262)
UCT REC 422/2007 & N2/19/8/2(2262)(2262)

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
Single group: all participants receive same intervention throughout study Non-randomised Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Rifampicin 600 mg daily 21 days Wk1 - ARV only; Wk2 rifampicin plus ARV standard dose; Wk 3 rifampicin plus ARV (dose increase 3tablets 2xdaily); wk 4 Rifampicin plus double dose ARV 24

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
¿ HIV-infected adults (>18 yr) ¿ Established on an antiretroviral regimen comprising LPV 400 mg/RTV 100 mg and 2 NRTIs > 6 months ¿ Undetectable viral load ¿ ALT normal ¿ Recent Hepatitis B virus surface antigen negative and HCV Ab negative ¿ Normal ECG at a screening visit ¿ Normal serum potassium at a screening visit ¿ Medically stable ¿ Previously failed to attain or maintain virological suppression on a protease inhibitor-containing regimen. ¿ Known to have chronic renal, hepatic or GIT disease that may interfere with the pharmacokinetics of the drugs studied. ¿ Known to have cardiac disease that may increase the risk for developing cardiac conduction abnormalities. ¿ ECG changes consistent with a prolonged PR interval (>0.20s) and QT prolongation as identified by using a QT correction formula. QT interval with Fridericia¿s correction > 480 ms. ¿ Hypo or hyperkalaemia, a family history of Long QT syndrome or on medication that may prolong the QT/QTc interval. ¿ Fasting cholesterol >7.77 mmol/L, fasting triglyceride > 8.49 mmol/L or abnormal glucose measurements at baseline or 6 monthly checks. ¿ Alcohol consumption in excess of 2 units/day or 14 units/week. ¿ Tuberculosis (TB) will be excluded by a structured symptom questionnaire. ¿ Receiving drugs other than the study medication known to potently induce or inhibit CYP3A4 or alter the PK of LPV ¿ Receiving drugs other than the study drugs whose PK is known to be altered by Aluvia®. ¿ Known or suspected pregnancy. ¿ Women of child-bearing potential who are not using a recognized form of contraception 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 UCT
Ethics Committee Address
Street address City Postal code Country

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The pharmacokinetics of adjusted dose lopinavir/ritonavir when dosed with rifampicin 1 weekly
Secondary Outcome Safety of adjusted dose lopinavir/ritonavir when dosed with rifampicin. 1 weekly

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gugulethu Clinic Cape Town South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
EDCDTP
EDCDTP

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UCT University
Primary Sponsor UCT University

COLLABORATORS
Name Street address City Postal code Country
Dr Concepta Merry Ireland
Dr Concepta Merry Ireland

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Dr Eric Decloedt eric.decloedt@uct.ac.za +27 21 406 6353
Street address City Postal code Country Position / Affiliation
South Africa
Role Name Email Phone Fax
Principal Investigator Prof Gary Maartens gary.maartens@uct.ac.za +27 21 406 6286
Street address City Postal code Country Position / Affiliation
Cape Town South Africa
Role Name Email Phone Fax
Scientific Enquiries Prof Pete Smith peter.smith@uct.ac.za +27 21 406 6289
Street address City Postal code Country Position / Affiliation
South Africa