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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.: PACTR2009120001702102 Date registered: 2009/11/24
TRIAL DESCRIPTION
Public title Food-Atripla pharmacokinetic study
Official scientific title Evaluation of the pharmacokinetics of Atripla® with and without food in HIV-1 infected Ugandan adults
Brief summary describing the background
and objectives of the trial
An open-label, multiple-dose, two-phase, intensive pharmacokinetic study evaluating the effect of a meal on the pharmacokinetics of Atripla®.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied HIV/AIDS ,
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) 15   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
HS 553 Uganda National Council for Science and Technology (UNCST)
HS 553 Uganda National Council for Science and Technology (UNCST)

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 Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Atripla administered with food Standardized breakfast provided on study Day 8 One tablet Atripla administered immediately after a standardized breakfast on Day 8 15
Experimental group Atripla administered without food No breakfast provided on Study Day 1 One tablet Atripla administered without a meal on Study Day 1 15

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1. HIV-1 infected male and non-pregnant female adults >18 years to < 65 years age 2. Stable on antiretroviral therapy containing TDF, FTC plus EFV for at least 1 month 3. No use of herbal/traditional medications or other medication known to induce or inhibit cytochrome P450 in previous 2 weeks 4. Ability to provide written informed consent 1. Anaemia (Hb < 10g/dl) 2. Evidence of pre-existing liver impairment (ALT > 5 times upper limit of normal) 3. Evidence of renal impairment (serum creatinine > 300) 4. Severe viral or bacterial infection (requiring hospitalization or parenteral antibioticis within 2 weeks of screening). 5. Vomiting or diarrhea lasting greater than 2 weeks within one month of screening. 6. Refusal to adhere to prescribed meal conditions for TDF/FTC/EFV administration. 18 Years 65 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 2009/02/13 Joint Clinical Research Centre IRB/REC
Ethics Committee Address
Street address City Postal code Country
Joint Clinical Research Centre Plot 893 Ring Road, Butikiro House-Mengo Kampala P. O. Box 10005 Uganda

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Plasma concentrations of antiretroviral agents administered with food or without food. Day 1 Day 8

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Joint Clinical and Research Centre Plot 893 Ring Road, Butikiro House Mengo Kampala P. O. Box 10005 Uganda

FUNDING SOURCES
Name of source Street address City Postal code Country
Health Research Board Ireland 73 Lower Baggot Street Dublin Dublin 2 Ireland
Health Research Board Ireland 73 Lower Baggot Street Dublin Dublin 2 Ireland

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Joint Clinical and Research Centre Plot 893 Ring Road, Butikiro House - Mengo Kampala Uganda Hospital
Primary Sponsor Joint Clinical and Research Centre Plot 893 Ring Road, Butikiro House - Mengo Kampala Uganda Hospital

COLLABORATORS
Name Street address City Postal code Country
Dr Cissy Kityo Joint Clinical and Research Centre Kampala Uganda
Dr Mohammed Lamorde Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda
Dr Pauline Byakika-Kibwika Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda
Dr Marta Boffito St Stephen's Centre, Chelsea and Westminster Hospital London United Kingdom
Dr Mairin Ryan Trinity College Dublin Dublin 2 Ireland
Professor David Back 70 Pembroke Place, Department of Pharmacology and Therapeutics, University of Liverpool Liverpool United Kingdom
Dr Concepta Merry Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda
Dr Cissy Kityo Joint Clinical and Research Centre Kampala Uganda
Dr Mohammed Lamorde Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda
Dr Pauline Byakika-Kibwika Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda
Dr Marta Boffito St Stephen's Centre, Chelsea and Westminster Hospital London United Kingdom
Dr Mairin Ryan Trinity College Dublin Dublin 2 Ireland
Professor David Back 70 Pembroke Place, Department of Pharmacology and Therapeutics, University of Liverpool Liverpool United Kingdom
Dr Concepta Merry Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Concepta Merry cmerry@tcd.ie +256-414-307245 +256-41-307290
Street address City Postal code Country Position / Affiliation
Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda Senior Research Associate
Role Name Email Phone Fax
Scientific Enquiries Dr Mohammed Lamorde mlamorde@idi.co.ug +256-772185590 +256-41-307290
Street address City Postal code Country Position / Affiliation
Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda Study Coordinator
Role Name Email Phone Fax
Public Enquiries Dr Mohammed Lamorde mlamorde@idi.co.ug +256-772185590 +256-41-307290
Street address City Postal code Country Position / Affiliation
Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda Study Coordinator