| - candidate number | 2422 |
| - NTR Number | NTR886 |
| - ISRCTN | ISRCTN81868024 |
| - 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 naïve |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | [default] |
| - Studytype | intervention |
| - 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. 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 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). |
| - Timepoints | |
| - 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. |
| - Funding (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 |
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