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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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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR886 |
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Date of registration:
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23/01/2007 |
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Primary sponsor: |
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Public title:
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A Randomised, Double-blind, Controlled Study on the Effect of One Year Administration of a Nutritional Concept on Immunological Status in HIV-1 Positive Adults not on Antiretroviral Therapy
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Scientific title:
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A Randomised, Double-blind, Controlled Study on the Effect of One Year Administration of a Nutritional Concept on Immunological Status in HIV-1 Positive Adults not on Antiretroviral Therapy - BITE (Blinded nutritional study for Immunity and Tolerance Evaluation) |
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Date of first enrolment:
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23/1/2007 |
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Target sample size:
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800 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=886 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Barbara
Mourmans |
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Address:
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Danone Research - Clinical Studies Platform
Bosrandweg 20, Danone Research - Clinical Studies Platform
Bosrandweg 20
6704 PH
Wageningen
The Netherlands |
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Telephone:
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+31 (0)317 467800 |
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Email:
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barbara.mourmans@danone.com |
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Affiliation:
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Name:
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Barbara
Mourmans |
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Address:
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Danone Research - Clinical Studies Platform
Bosrandweg 20, Danone Research - Clinical Studies Platform
Bosrandweg 20
6704 PH
Wageningen
The Netherlands |
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Telephone:
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+31 (0)317 467800 |
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Email:
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barbara.mourmans@danone.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Main inclusion criteria:
1. HIV-1 positive adults who have not received (HA)ART in the past year and are not anticipated to start therapy within the next 6 months;
2. HIV-1 RNA > 5,000 copies/ml in the 3 months prior to screening visit;
3. CD4+ T-cell count ≤ 800 cells/µl in the 3 months prior to screening visit;
4. ≥ 18 years old.
Exclusion criteria: Main exclusion criteria:
1. (HA)ART anticipated to be required within the next 6 months;
2. Unintended weight loss of more than 10% in the 3 months prior to screening visit.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Human immunodeficiency virus (HIV), Nutrition, Immune status, HAART naïve
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Intervention(s)
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Intervention group:
A nutritional concept containing specific selected ingredients.
Control group:
Isocaloric nutritional product with an almost identical appearance and flavour as the investigational product though without the specific selected ingredients.
Patients will be supplied with either a nutritional test or a control product for a period of 12 months.
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Primary Outcome(s)
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Change from baseline in CD4+ T-cell count during 12 months.
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Secondary Outcome(s)
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1. Changes from baseline during one year in:
a.Immune markers other than CD4+ T-cell count;
b. Viral load (HIV-1 RNA).
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Secondary ID(s)
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ISRCTN81868024
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N/A
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Source(s) of Monetary Support
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Danone Research B.V.
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