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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21548

Enrollment

800

Registered

2007-01-23

Start date

2007-01-23

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 positive adults not on (HA)ART

Interventions

Intervention group: A nutritional concept containing specific selected ingredients. Control group: Isocaloric nutritional product with an almost identical appearance and flavour as the investigatio

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Change from baseline in CD4+ T-cell count during 12 months.	—

Secondary

Measure	Time frame
1. Changes from baseline during one year in: a.Immune markers other than CD4+ T-cell count; b. Viral load (HIV-1 RNA).	—

Contacts

Public ContactBarbara Mourmans

Danone Research - Clinical Studies Platform Bosrandweg 20

barbara.mourmans@danone.com+31 (0)317 467800

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)