|- candidate number||2422|
|- NTR Number||NTR886|
|- Date ISRCTN created||26-feb-2007|
|- date ISRCTN requested||21-feb-2007|
|- Date Registered NTR||23-jan-2007|
|- Secondary IDs||N/A |
|- Public Title||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|
|- Scientific Title||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|
|- ACRONYM||BITE (Blinded nutritional study for Immunity and Tolerance Evaluation)|
|- hypothesis||Improving the immunological status of HIV-1 infected adults not on antiretroviral therapy through nutritional support. |
|- Healt Condition(s) or Problem(s) studied||Human immunodeficiency virus (HIV), Nutrition, Immune status, HAART na´ve|
|- 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/Ál 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||23-jan-2007|
|- planned closingdate||30-apr-2009|
|- Target number of participants||800|
|- Interventions||Intervention group:
A nutritional concept containing specific selected ingredients.
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 outcome||Change from baseline in CD4+ T-cell count during 12 months.|
|- Secondary outcome||1. Changes from baseline during one year in:
a.Immune markers other than CD4+ T-cell count;
b. Viral load (HIV-1 RNA).
|- Trial web site||N.A.|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MSc Barbara Mourmans|
|- CONTACT for SCIENTIFIC QUERIES||MSc Barbara Mourmans|
|- Sponsor/Initiator ||Danone Research B.V.|
(Source(s) of Monetary or Material Support)
|Danone Research B.V. |
|- Publications||(Abstract (including oral presentation) for) ICAAC 2009, San Francisco|
|- Brief summary||HIV-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|
|- RECORD||23-jan-2007 - 7-okt-2009|