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.: PACTR201103000279108 Date of Approval: 11/03/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title CHAPAS-2
Official scientific title Children with HIV in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens
Brief summary describing the background and objectives of the trial simplification and standardisation of ARV therapy is an essential feature of HIV treatment scale up. CHAPAS-2 will determine PK of Cipla LPV/r in paediatric tablet, sprinkle and Abbott LPV/r syrup formulation when taken with food and used in combination with other appropriate first-line drugs for infants perinatally exposed to Nevirapine, or with second-line drugs following first-line failure in African HIV infected children. The acceptability on use and formulation preferences will be assessed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CHAPAS 2
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/04/2011
Actual trial start date 15/08/2011
Anticipated date of last follow up 31/10/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Randomised Stratified allocation where factors such as age, gender, centre, or previous treatment are used in the stratification Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Arm 1 twice daily, based on children's weight 4 weeks then change formulation LPV/r tablets for 4 weeks then change to LPV/r sprinkles 12 Active-Treatment of Control Group
Control Group Arm 2 Twice daily, based on children's weight 4 weeks then change formulation LPV/r sprinkle for 4 weeks then change to LPV/r tablets 12 Active-Treatment of Control Group
Control Group Arm 3 Twice daily, based on children's weight 4 weeks then change formulation LPV/r syrup for 4 weeks then change to LPV/r sprinkle 16 Active-Treatment of Control Group
Control Group Arm 4 Twice daily based on children's weight 4 weeks then change formulation LPV/r sprinkle for 4 weeks then change to LPV/r syrup 12 Active-Treatment of Control Group
Control Group Arm 5 twice daily, based on children's weight 4 weeks then change formulation LPV/r syrup for 4 weeks then change to LPV/r sprinkles 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) HIV infected infants aged 3 months to <12 months currently taking or about to start LPV/r syrup based first-line following WHO guidelines 2008 [7]. OR HIV infected children able to swallow paediatric LPV/r tablets and aged 4-13 years and <25Kg, currently taking or about to start LPV/r based second-line following WHO guidelines. OR HIV infected infants aged 1 to 4 years currently taking or about to start LPV/r syrup based first-line 2. Carers, and children where appropriate, willing and able to give informed consent Children: 1. Who are expected to change weight bands (i.e. change dose) after enrolment and before PK day at week 8 2. With anaemia (haemoglobin <8.5g/dL), or liver enzymes grade 2 or higher. 3. With illnesses that could influence the pharmacokinetics of the antiretroviral (ARV) drugs at week 4 and week 8 e.g. severe diarrhoea, vomiting, renal or liver disease 4. On concomitant medications that are known to interact with the ARV drugs 3 Month(s) 13 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 30/10/2009 Joint Clinical Research Centre IRB
Ethics Committee Address
Street address City Postal code Country
Plot 893 ring Road Butikiro House - Mengo Kampala Uganda
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 23/04/2010 Ugandan National Council for Science and Technoology
Ethics Committee Address
Street address City Postal code Country
Plot 3/5/7 Nasser Road Kampala Uganda
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 29/12/2010 National Drug Authority
Ethics Committee Address
Street address City Postal code Country
Plot 46 - 48 Lumumba Avenue Kampala Uganda
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 19/10/2009 UCL Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University College London Gower Street London WC1E 6BT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine the pharmacokinetics of ritonavir-boosted-lopinavir (LPV/r) in twice daily paediatric co-formulated fixed dose sprinkle combination (lopimune) Compared to LPV/r in a twice daily paediatric co-formulated fixed dose tablet combination Both with food HIV-infected African Children age 4 - 12 years
Primary Outcome To determine the pharmacokinetics of ritonavir-boosted-lopinavir (LPV/r) in twice daily paediatric co-formulated fixed dose sprinkle combination (lopimune) Compared to LPV/r in a twice daily paediatric co-formulated fixed dose syrup Both with food HIV-infected African infants under 1 year of age
Primary Outcome To determine the pharmacokinetics of ritonavir-boosted-lopinavir (LPV/r) in twice daily paediatric co-formulated fixed dose sprinkle combination (lopimune) Compared to LPV/r in a twice daily paediatric co-formulated fixed dose tablet combination Both with food HIV-infected African Children age 4 - 12 years
Primary Outcome To determine the pharmacokinetics of ritonavir-boosted-lopinavir (LPV/r) in twice daily paediatric co-formulated fixed dose sprinkle combination (lopimune) Compared to LPV/r in a twice daily paediatric co-formulated fixed dose syrup Both with food HIV-infected African infants and children aged 1 to 4 years of age
Secondary Outcome Compare formulation preferences of children and their carers In terms of sprinkle or tablets
Secondary Outcome Compare formulation preferences of infants' carers In terms of sprinkles or syrup
Secondary Outcome Evaluate the effects of age, sex, severity of illness and anthropometric measurements on PK parameters for LPV/r weight for age; height-for-age; BMI; middle upper arm circumference (MUAC); malnutrition indices; Specifically to examine whether malnutrition modifies the pharmacokinetic characteristics of boosted PIs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Paediatric Infections Disease Clinic - Baylor College of Medicine Children's Foundation, Uganda Department of Paediatrics PO Box 7072 Makerere, Kampala Uganda
Joint Clinical Research Centre PO Box 10005 Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
The Monument Trust 150 Victoria Street London SW1E 5AE United Kingdom
Drugs for Neglected Diseases Initiative 15 Chemin Louis Dunant 1202 Geneva Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Council Aviation House, 125 Kingsway London WC2B 6NH United Kingdom Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dept of Clinical Pharmacy Radbound University 864 Radbound University Nijmegen Medical Center Njimegen 6525 GA Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Diana Gibb dmg@ctu.mrc.ac.uk 44 207 6704709 125 Kingsway
City Postal code Country Position/Affiliation
London WC2B 6NH United Kingdom Prof Epidemiology / Hon Consultant Paediatrician
Role Name Email Phone Street address
Public Enquiries Natalie Young nyo@ctu.mrc.ac.uk 02076704766 Aviation House, 125 Kingsway
City Postal code Country Position/Affiliation
London WC2B 6NH United Kingdom Data Manager
Role Name Email Phone Street address
Public Enquiries Bethany Naidoo bn@ctu.mrc.ac.uk +44 207 6704775 125 Kingsway
City Postal code Country Position/Affiliation
London WC2B 6NH United Kingdom Clinical Trial Manager
Role Name Email Phone Street address
Scientific Enquiries Margaret Thomason mjth@ctu.mrc.ac.uk +44 207 6704615 125 Kingsway
City Postal code Country Position/Affiliation
London WC2B 6NH United Kingdom Clinical Project Manager
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information