A randomised, double-blind, controlled study on the effect of one year administration of a nutritional concept on immunological status in human immunodeficiency virus-1 positive adults not on anti-retroviral therapy

Completed

• Conditions: HIV; Infections and Infestations

• Registration Number: ISRCTN81868024
• Lead Sponsor: umico Research B.V. (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 800

Inclusion Criteria

Main inclusion criteria:
1. HIV-1 positive adults who have not received (Highly Active) Anti-Retroviral Therapy ([HA]ART) in the past year and are not anticipated to start therapy within the next six months
2. HIV-1 Ribonucleic Acid (RNA) more than 5,000 copies/ml in the three months prior to screening visit
3. CD4+ T-cell count less than or equal to 800 cells/µl in the three months prior to screening visit
4. More than or equal to 18 years old

Exclusion Criteria

Main exclusion criteria:
1. (HA)ART anticipated to be required within the next six months
2. Unintended weight loss of more than 10% in the three months prior to screening visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified