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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


- candidate number2422
- NTR NumberNTR886
- ISRCTNISRCTN81868024
- Date ISRCTN created26-feb-2007
- date ISRCTN requested21-feb-2007
- Date Registered NTR23-jan-2007
- Secondary IDsN/A 
- Public TitleA 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
- Scientific TitleA 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
- ACRONYMBITE (Blinded nutritional study for Immunity and Tolerance Evaluation)
- hypothesisImproving the immunological status of HIV-1 infected adults not on antiretroviral therapy through nutritional support.
- Healt Condition(s) or Problem(s) studiedHuman immunodeficiency virus (HIV), Nutrition, Immune status, HAART na´ve
- Inclusion criteriaMain 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/Ál in the 3 months prior to screening visit; 4. ≥ 18 years old.
- Exclusion criteriaMain 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 23-jan-2007
- planned closingdate30-apr-2009
- Target number of participants800
- InterventionsIntervention 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.
- Primary outcomeChange from baseline in CD4+ T-cell count during 12 months.
- Secondary outcome1. Changes from baseline during one year in: a.Immune markers other than CD4+ T-cell count; b. Viral load (HIV-1 RNA).
- Timepoints
- Trial web siteN.A.
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc Barbara Mourmans
- CONTACT for SCIENTIFIC QUERIESMSc Barbara Mourmans
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- Publications(Abstract (including oral presentation) for) ICAAC 2009, San Francisco
- Brief summaryHIV-1 infection is a major disease. Different pharmaceutical therapies have been developed over the years, turning HIV infection from an acute disease into a chronic disease. The disease is characterized by a progressive deterioration of the immune function, resulting in multiple opportunistic pathologies. Disease progression is monitored by the decrease in the CD4+ T-lymphocyte population, the target cell for viral replication. Apart from the decrease in CD4+ T-cells, many other physiological functions are also altered in the HIV-infected patient as the disease progresses resulting in a decreased overall health status. This clinical trial will be a multicenter, randomised double-blind study to be executed at a number of clinical trial sites on various continents. Adult HIV-1 infected patients not on antiretroviral therapy (n=800) will be selected for the trial. Patients will be supplied with either a nutritional test or a control product for a period of 12 months. The change in CD4+ T-cell counts will be monitored at relevant timepoints. In addition, other immune markers as well as viral load will be studied.
- Main changes (audit trail)Contact changed from Remko Hiemstra to Barbara Mourmans: 7-okt-2009- Jurre Status changed to closed -7-okt-2009- Jurre Added publication -7-okt-2009- Jurre
- RECORD23-jan-2007 - 7-okt-2009


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