Tolerance and immunological response in human immunodeficiency virus (HIV) seropositive individuals after NR100063 supplementation: a randomised double-blind placebo-controlled three-arm parallel study

Danone Research B.V. (Netherlands)0 个研究点目标入组 60 人开始时间: 2010年7月29日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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

•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

发起方

Danone Research B.V. (Netherlands)