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

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.

Improving the immunological status of HIV-1 infected adults not on antiretroviral therapy through nutritional support.

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.