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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201103000279108 |
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Date of registration:
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11/03/2011 |
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Primary sponsor: |
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Public title:
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CHAPAS-2
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Scientific title:
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Children with HIV in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens |
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Date of first enrolment:
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2011-08-15 |
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Target sample size:
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64 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201103000279108 |
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Study type:
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interventional |
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Study design:
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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 ,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Margaret
Thomason |
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Address:
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125 Kingsway
WC2B 6NH
London
United Kingdom |
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Telephone:
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+44 207 6704615 |
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Email:
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mjth@ctu.mrc.ac.uk |
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Affiliation:
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Clinical Project Manager |
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Name:
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Bethany
Naidoo |
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Address:
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125 Kingsway
WC2B 6NH
London
United Kingdom |
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Telephone:
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+44 207 6704775 |
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Email:
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bn@ctu.mrc.ac.uk |
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Affiliation:
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Clinical Trial Manager |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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
Age minimum:
3 Month
Age maximum:
13 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
null
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Primary Outcome(s)
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To determine the pharmacokinetics of ritonavir-boosted-lopinavir (LPV/r) in twice daily paediatric co-formulated fixed dose sprinkle combination (lopimune)
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Secondary Outcome(s)
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Compare formulation preferences of children and their carers
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Compare formulation preferences of infants' carers
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Evaluate the effects of age, sex, severity of illness and anthropometric measurements on PK parameters for LPV/r
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Source(s) of Monetary Support
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Drugs for Neglected Diseases Initiative
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The Monument Trust
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