No registrations found.
ID
Source
Brief title
Health condition
HIV-1 positive adults not on (HA)ART
Sponsors and support
Intervention
Outcome measures
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).
Background 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.
Study objective
Improving the immunological status of HIV-1 infected adults not on antiretroviral therapy through nutritional support.
Intervention
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.
Bosrandweg 20
Barbara Mourmans
Danone Research - Clinical Studies Platform
Bosrandweg 20
Wageningen 6704 PH
The Netherlands
+31 (0)317 467800
barbara.mourmans@danone.com
Bosrandweg 20
Barbara Mourmans
Danone Research - Clinical Studies Platform
Bosrandweg 20
Wageningen 6704 PH
The Netherlands
+31 (0)317 467800
barbara.mourmans@danone.com
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL872 |
| NTR-old | NTR886 |
| Other | : N/A |
| ISRCTN | ISRCTN81868024 |