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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: |
PACTR201106000300631 |
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Date of registration:
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31/05/2011 |
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Primary sponsor: |
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Public title:
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NUSTART
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Scientific title:
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Nutritional support for African adults starting antiretroviral therapy |
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Date of first enrolment:
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2011-08-29 |
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Target sample size:
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2300 |
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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=PACTR201106000300631 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Simple randomisation using a randomisation table created by a computer software programme,
Numbered containers generated by DSMB statistician off-site,
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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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Yolanda
Fernandez |
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Address:
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Keppel Street
WC1E 7HT
London
United Kingdom |
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Telephone:
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+44 20 7958 8108 |
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Email:
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Yolanda.Fernandez@lshtm.ac.uk |
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Affiliation:
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Project Administrator |
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Name:
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Suzanne
Filteau |
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Address:
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LSHTM, Keppel St
WC1E 7HT
London
United Kingdom |
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Telephone:
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+44 20 79588108 |
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Email:
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suzanne.filteau@lshtm.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: at least 18 years old;
ART-naive (except for standard regimens to prevent maternal-to-child HIV transmission);
BMI ` 18.5 kg/m2. In the presence of clinical oedema and a BMI ` 20 kg/m2, BMI will be re-measured after loss of oedema, and the patient considered eligible if BMI ` 18.5 kg/m2 and ART has not yet been initiated;
requiring ART as determined by CD4 count ` 350/ul or stage 3 or 4 disease;
willing to undertake intensive ART follow-up in the study clinic;
providing written, fully informed consent (thumbprint will be accepted)
Exclusion criteria: participation in a potentially conflicting research protocol;
pregnancy (by self-report)
Age minimum:
18 Year
Age maximum:
80 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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Mortality
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Secondary Outcome(s)
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Any SAE
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Appetite
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Change in fat-free mass and fat mass
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Grip strength
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Hospitalisation
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Iron status
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Plasma electrolytes
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Weight gain
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Source(s) of Monetary Support
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EDCTP
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