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.: PACTR201301000480567 Date of Approval: 07/01/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Rilpivirine Food PK Study
Official scientific title EFFECT OF FOOD ON THE STEADY-STATE PHARMACOKINETICS OF RILPIVIRINE WHEN ADMINISTERED AS A FIXED-DOSE COMBINATION IN HIV-1 INFECTED UGANDAN ADULTS
Brief summary describing the background and objectives of the trial Food insufficiency affects up to a third of the population in sub-Saharan Africa. Food intake also influences the bioavailability of orally administered drugs. Primary objectives To investigate the steady-state pharmacokinetics (PK) of rilpivirine in HIV-1 infected Ugandan patients when Complera® is administered under three different meal conditions. Secondary objectives To assess the short-term safety and tolerability of Complera® in HIV-1 infected patients
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2013
Actual trial start date 03/04/2013
Anticipated date of last follow up 30/06/2013
Actual Last follow-up date 31/07/2013
Anticipated target sample size (number of participants) 15
Actual target sample size (number of participants) 15
Recruitment status Completed
Publication URL http://www.ncbi.nlm.nih.gov/pubmed/25652748
Secondary Ids Issuing authority/Trial register
HS 1262 Uganda National Council for Science and Technology
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)
Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tablets Complera (200mg emtricitabine, 25 mg rilpivirine, 300mg TDF) One tablet daily 56 days Complera® tablets will be swallowed daily from Day 1 to Day 56. On days 42, 43, 49, 50 and 56, patients will administer Complera® in hospital under direct supervision. On all other days, Complera® will be self-administered at home after food. Pharmacokinetic sampling will be performed on Day 42 (Complera dosing in fasted state), 49 (low fat meal) and 56 (moderate fat meal). 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Aged between 18 to 65 years, inclusive. 4. Diagnosed with HIV-1 infection 5. Receiving first-line ART containing tenofovir disoproxil fumarate, efavirenz plus either emtricitabine or lamivudine for a minimum of 6 months 1. HIV-1 RNA > 400 copies/mL at screening visit 2. Serum hemoglobin < 8g/dl 3. Elevations in serum levels of alanine transaminase (ALT), aspartate transaminase (AST) or creatinine above 3 times the upper limit of normal 4. Evidence of QT prolongation on electrocardiogram (ECG) QTc (Rate adjusted QT interval) >450ms (men) or >470ms (women) 5. History of cardiac disease 6. Diarrhea lasting greater than one week 7. Use of known inhibitors or inducers of CYP3A4 . 8. Use of antacids, histamine-2 blockers or proton pump inhibitors 9. Use of herbal medications (information will be obtained from patients¿ medication history through interview with the patient) 10. Consumption of grapefruit within 1 week of first dose of study drug and for the duration of the study 11. Pregnant or lactating females 12. Participation in other clinical studies within four weeks before the current study begins and/or during study participation. Subjects should not be concurrently enrolled in another clinical trial. 18 Year(s) 65 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 30/08/2012 Joint Clinical Research Centre IRB
Ethics Committee Address
Street address City Postal code Country
Plot 101 Lubowa, Off Entebbe Road Kampala 256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Steady-state plasma concentrations of rilpivirine Day 42 Day 49 Day 56
Secondary Outcome Short-term safety and tolerability of Complera® in HIV-1 infected patients Day 42 Day 49 Day 56 Day 70
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Infectious Diseases Institute, Mulago Hospital Complex Mulago Hill Road Kampala 256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Janssen Pharmaceutica Turnhoutseweg, 30 Beerse Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Infectious Diseases Institute, Makerer University College of Health Sciences Mulago Hospital Complex, Kampala Uganda University
COLLABORATORS
Name Street address City Postal code Country
Pauline Byakika-Kibwika Infectious Diseases Institute, Mulago Hospital Complex Kampala 0256 Uganda
Esther Lubwama Infectious Diseases Institute, Mulago Hospital Complex Kampala 0256 Uganda
Michael Katwere Infectious Diseases Institute, Mulago Hospital Complex Kampala 0256 Uganda
Concepta Merry Trinity College Dublin Dublin 2 Ireland
David Back 70 Pembroke Place, University of Liverpool Liverpool United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Lamorde mlamorde@idi.co.ug +256-414-307291 Infectious Diseases Institute, Mulago Hospital Complex, Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Research Fellow / Infectious Diseases Institute
Role Name Email Phone Street address
Public Enquiries Michael Enyakoit menyakoit@idi.co.ug +256-414-307224 Infectious Diseases Institute, Mulago Hospital Complex, Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Regulatory Officer / Infectious Diseases Institute
Role Name Email Phone Street address
Scientific Enquiries Mohammed Lamorde mlamorde@idi.co.ug +256-414-307291 Infectious Diseases Institute, Mulago Hospital Complex, Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala 0256 Uganda Research Fellow / Infectious Diseases Institute
REPORTING
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