Tolerance and immunological response in human immunodeficiency virus (HIV) seropositive individuals after NR100063 supplementatio

Completed

• Conditions: Human immunodeficiency virus (HIV); Infections and Infestations; Human immunodeficiency virus

• Registration Number: ISRCTN30730587
• Lead Sponsor: Danone Research B.V. (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Treatment-naïve HIV-positive individuals with no stage 3 illness
2. At least 18 years of age
3. Males or non-pregnant, non-lactating females
4. Never received antiretroviral treatment
5. CD4+ T-cell counts between 400 and 800 cells/uL
6. Plasma HIV-1 ribonucleic acid (RNA) levels between 1,000 and 65,000 copies/m

Exclusion Criteria

1. Self reported vaccination during the 2 months prior to inclusion, or intention to be vaccinated during study period
2. Acute febrile illness
3. Current antibiotic use
4. Current use of corticosteroids or other immune modulating medications
5. Self reported history of IL-2 administration or other vaccine candidates in the past 5 years
6. The use of probiotics or fibres in nutritional health products or supplements
7. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements, such as drug or alcohol abuse, mental disorder
8. Participation (or intention to participate) in any other studies involving investigational or marketed products concomitantly or within four weeks prior to entry into the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified