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.: PACTR2010030001953121 Date of Approval: 02/03/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Second-line antiretrovirals - Food interaction study
Official scientific title Evaluation of the steady-state pharmacokinetics of second-line antiretroviral drugs when administered under different meal conditions in HIV-infected Ugandan adults
Brief summary describing the background and objectives of the trial An open-label, multiple dose, three phase, crossover, intensive pharmacokinetic study evaluating the effect of different meal conditions on the pharmacokinetics of second-line antiretroviral drugs in Ugandan adults
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 15/03/2010
Actual trial start date 01/04/2010
Anticipated date of last follow up 31/07/2010
Actual Last follow-up date 30/07/2010
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/22481601
Secondary Ids Issuing authority/Trial register
HS730 Uganda National Council for Science and Technology
HS730 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not 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
Control Group Antiretroviral drugs administered with a moderate fat meal Moderate fat meal administered with antiretroviral drugs on Study Day 1 Two tablets of Aluvia plus two nucleoside reverse transcriptase inhibitors administered after a moderate fat meal on Study Day 1 15
Experimental Group Antiretroviral drugs administered with a high fat meal High fat meal administered with antiretroviral drugs on Study Day 8 Two tablets of Aluvia plus two nucleoside reverse transcriptase inhibitors administered after a high fat meal on Study Day 8 15
Experimental Group Antiretroviral drugs administered without food No breakfast provided on Study Day 15 Two tablets of Aluvia plus two nucleoside reverse transcriptase inhibitors administered in a fasting state on Study Day 15 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. HIV-infected male and non pregnant female adults > 18 and < 65 years of age 2. On ART containing lopinavir/ritonavir (LPV/r) plus 2NRTI with undetectable viremia (most recent HIV-RNA performed over preceding 12 months measuring <400 copies/ml) 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 full written informed consent 1. Anaemia ( Hemoglobin) < 10 g/dl 2. Evidence of liver impairment ALT > 5 times upper limit of normal 3. Evidence of renal impairment ( serum creatinine > 300 ) 4. Severe bacterial or viral infection (requiring hospitalization or parenteral antibiotics within 2 weeks of screening) 5. Vomiting or diarrhoea lasting greater than 2 weeks within one month of screening 6. Refusal to adhere to prescribed meal conditions during administration of LPV/r plus 2 NRTIs 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 23/11/2009 National HIV/AIDS Research Committee, Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 3/5/7 Nasser Road Kampala Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Plasma concentrations of antiretroviral drugs when administered under different meal conditions Day 1, Day 8, Day 15
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Infectious Diseases Institute College of Health Sciences, Makerere University, Mulago Hospital Complex Kampala 00256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Health Research Board of Ireland 73 Lower Baggot street Dublin Dublin 2 Ireland
Health Research Board of Ireland 73 Lower Baggot street Dublin Dublin 2 Ireland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Infectious Diseases Institute College of Health Sciences, Makerere University Kampala Uganda University
Primary Sponsor Infectious Diseases Institute College of Health Sciences, Makerere University Kampala Uganda University
COLLABORATORS
Name Street address City Postal code Country
Dr Mohammed Lamorde Infectious Diseases Institute, College of Health Sciences, Makerere University 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 Pauline Byakika-Kibwika Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda
Professor Jasper Ogwal-Okeng Department of Pharmacology and Therapeutics, Makerere University Kampala Uganda
Professor Jasper Ogwal-Okeng Department of Pharmacology and Therapeutics, Makerere University Kampala Uganda
Dr Mairin Ryan Trinity College Dublin Dublin 2 Ireland
Dr Mairin Ryan Trinity College Dublin Dublin 2 Ireland
Dr Marta Boffito St Stephens Centre, Chelsea and Westminster Hospital London United Kingdom
Dr Marta Boffito St Stephens Centre, Chelsea and Westminster Hospital London United Kingdom
Professor David Back Department of Pharmacology and Therapeutics, 70 Pembroke Place, University of Liverpool Liverpool United Kingdom
Professor David Back Department of Pharmacology and Therapeutics, 70 Pembroke Place, University of Liverpool Liverpool United Kingdom
Dr Concepta Merry Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda
Dr Concepta Merry Infectious Diseases Institute, College of Health Sciences, Makerere University Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Concepta Merry cmerry@tcd.ie (256) 414 307245 Infectious Diseases Institute, College of Health Sciences, Makerere University
City Postal code Country Position/Affiliation
Kampala Uganda Senior Research Associate
Role Name Email Phone Street address
Public Enquiries Margaret Denty mdenty@idi.co.ug (256) 414 307319 Infectious Diseases Institute, College of Health Sciences, Makerere University
City Postal code Country Position/Affiliation
Kampala Uganda Regulatory Affairs Officer
Role Name Email Phone Street address
Scientific Enquiries Mohammed Lamorde mlamorde@idi.co.ug (245) 772185590 Infectious Diseases Institute, College of Health Sciences, Makerere University
City Postal code Country Position/Affiliation
Kampala Uganda Study Coordinator
REPORTING
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