Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000516583
Ethics application status
Not yet submitted
Date submitted
28/11/2006
Date registered
14/12/2006
Date last updated
14/12/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a food product on the immune system of HIV positive adults who do not use HIV inhibitors
Scientific title
The effect of a food product on changes to the immune system of HIV positive adults who do not use HIV inhibitors
Universal Trial Number (UTN)
Trial acronym
BITE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human immunodeficiency virus (HIV) 1493 0
Condition category
Condition code
Infection 1590 1590 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nutrtional intervention study.
The purpose of the study is to determine the effect of daily use (twice a day at anytime) of a food product for a period of one year among HIV positive patients. The study will be carried out in approximately 10 countries and approximately 800 patients will participate. Half of the patients will receive the active food product and half will receive the control food product. The food product consists of a mix of ingredients, including special proteins, fats, vitamins, minerals and fibres. Daily intake for the food products is as follows; Total fat 7.25g, Total protein 16.3g, Total carbohydrates 44.6g and oligosaccharides (soluble fibres) 15.0 g.
Intervention code [1] 1473 0
Treatment: Other
Comparator / control treatment
The control product is comprised of standard protein, carbohydrate and fatty acid sources to match the caloric intake of the active product.
Control group
Active

Outcomes
Primary outcome [1] 2194 0
To assess the effect of the food product (NR100157 - product code number) on immunological status as measured by CD4+ T-cell count (a specific T-cell lymphocte count).
Timepoint [1] 2194 0
CD4+ T-cell count will be measured at baseline and at approximately every 13 weeks to see if the food product improves immunological status, as determined by a decrease in CD4+ T-cell count .
Secondary outcome [1] 3824 0
To assess the effect of the food product (NR100157 - product code number) on: immune markers other than CD4+ T-cell count; viral load (HIV-1 RNA), weight, growth factors, study product compiance, study product appreciation, gastrointestinal tolerance, safety.
Timepoint [1] 3824 0
Assessments will be made at baseline and at approximately every 13 weeks. The primary study parameter will be a change from baseline.

Eligibility
Key inclusion criteria
HIV-1 positive adults who have not received highly active antiretroviral therapy ((HA)ART) in the past year and are not anticipated to start therapy within the next 6 months, HIV-1 infected for at least 6 months, HIV-1 RNA > 5,000 copies/ml, CD4+ T-cell count less than or equal to 800 cells/microlitre in the 3 months prior to screening.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(HA)ART anticipated to be required within the first 6 months, allergy to milk and milk products, known diabetes mellitus type I or II, chronic renal disease requiring dialysis.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Provided by Sponsor using central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Provided by Sponsor - random order generation using permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients, clinicians (investigators) and assessors (study monitors) are blinded to the study treatment
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1735 0
Commercial sector/Industry
Name [1] 1735 0
Royal Numico
Country [1] 1735 0
Netherlands
Primary sponsor type
Commercial sector/Industry
Name
Royal Numico, Netherlands
Address
Country
Netherlands
Secondary sponsor category [1] 1529 0
None
Name [1] 1529 0
Nil
Address [1] 1529 0
Country [1] 1529 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3206 0
Melbourne Sexual Heralth Centre
Ethics committee address [1] 3206 0
Ethics committee country [1] 3206 0
Australia
Date submitted for ethics approval [1] 3206 0
Approval date [1] 3206 0
Ethics approval number [1] 3206 0
Ethics committee name [2] 3207 0
Prahran Market Clinic
Ethics committee address [2] 3207 0
Ethics committee country [2] 3207 0
Australia
Date submitted for ethics approval [2] 3207 0
Approval date [2] 3207 0
Ethics approval number [2] 3207 0
Ethics committee name [3] 3208 0
Carlton Clinic
Ethics committee address [3] 3208 0
Ethics committee country [3] 3208 0
Australia
Date submitted for ethics approval [3] 3208 0
Approval date [3] 3208 0
Ethics approval number [3] 3208 0
Ethics committee name [4] 3209 0
AIDS Research Initiative
Ethics committee address [4] 3209 0
Ethics committee country [4] 3209 0
Australia
Date submitted for ethics approval [4] 3209 0
Approval date [4] 3209 0
Ethics approval number [4] 3209 0
Ethics committee name [5] 3210 0
Taylor Square Clinic
Ethics committee address [5] 3210 0
Ethics committee country [5] 3210 0
Australia
Date submitted for ethics approval [5] 3210 0
Approval date [5] 3210 0
Ethics approval number [5] 3210 0

Summary
Brief summary
Numico Research has developed a food product which is available as a food bar and as a food powder that can be dissolved in water. The food product consists of a mix of ingredients, including special proteins, fats, vitamins, minerals and fibres. The special balance of these ingredients in the food product is expected to have a beneficial effect on the immune system. The purpose of the study is to determine the effect of the daily use of this food product for a period of one year among HIV positive adults. If the study results are favourable, the food product can be developed further to support the treatment of HIV positive patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27407 0
Address 27407 0
Country 27407 0
Phone 27407 0
Fax 27407 0
Email 27407 0
Contact person for public queries
Name 10662 0
Yvonne Lungershausen
Address 10662 0
Sansom Institute
Centre for Pharmaceutical Research
University of South Australia
Level 4 Reid Building
Frome Road
Adelaide SA 5000
Country 10662 0
Australia
Phone 10662 0
+61 8 83022736
Fax 10662 0
+61 8 83021163
Email 10662 0
yvonne.lungershuasen@unisa.edu.au
Contact person for scientific queries
Name 1590 0
Yvonne Lungershausen
Address 1590 0
Sansom Institute
Centre for Pharmaceutical Research
University of South Australia
Level 4 Reid Building
Frome Road
Adelaide SA 5000
Country 1590 0
Australia
Phone 1590 0
+61 8 83022736
Fax 1590 0
+61 8 83021163
Email 1590 0
yvonne.lungershuasen@unisa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.