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.: PACTR201206000159453 Date of Approval: 17/02/2010
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Tuberculosis
Purpose of the trial Treatment: Other
Anticipated trial start date 05/01/2009
Actual trial start date
Anticipated date of last follow up 22/06/2010
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
UCT REC 422/2007 & N2/19/8/2(2262)(2262)
UCT REC 422/2007 & N2/19/8/2(2262)(2262)
MCC 20080242
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
Non-randomised Open-label(Masking Not Used)
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 Age Category Minimum age Maximum 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 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 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 Street address
Principal Investigator Gary Maartens gary.maartens@uct.ac.za +27 21 406 6286
City Postal code Country Position/Affiliation
Cape Town South Africa
Role Name Email Phone Street address
Public Enquiries Eric Decloedt eric.decloedt@uct.ac.za +27 21 406 6353
City Postal code Country Position/Affiliation
South Africa
Role Name Email Phone Street address
Scientific Enquiries Pete Smith peter.smith@uct.ac.za +27 21 406 6289
City Postal code Country Position/Affiliation
South Africa
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information