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
Completed
- Conditions
- HIV-1 positive adults not on (HA)ART
- Registration Number
- NL-OMON21548
- Lead Sponsor
- umico Research B.V.
- Brief Summary
(Abstract (including oral presentation) for) ICAAC 2009, San Francisco
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 800
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in CD4+ T-cell count during 12 months.
- Secondary Outcome Measures
Name Time Method 1. Changes from baseline during one year in:<br>a.Immune markers other than CD4+ T-cell count;<br>b. Viral load (HIV-1 RNA).<br>