The effect of a food product on the immune system of HIV positive adults who do not use HIV inhibitors
- Conditions
- Human immunodeficiency virus (HIV)Infection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12606000516583
- Lead Sponsor
- Royal Numico, Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 800
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).[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 Measures
Name Time Method 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.[Assessments will be made at baseline and at approximately every 13 weeks. The primary study parameter will be a change from baseline.]