Human immunodeficiency virus (HIV) Infections and Infestations Human immunodeficiency virus
Conditions
Interventions
Group 1 (n = 20): Double dose
supplementation for 12 weeks plus 4 weeks supplement-free follow up
Group 2 (n = 20): Single dose
supplementation for 12 weeks plus 4 weeks
supplement-free follow up
Group 3 (n = 20): Placebo/control
supplementation for 12 weeks plus 4 weeks supplement-free follow up
Dose regimen: 3 times daily x 16 grams = 48 grams of powder per day (for all three arms). Of these 48 grams, the double dose group
Sponsors
Danone Research B.V. (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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/mL
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The determination of tolerance and safety during the supplementation period. Blood samples drawn at baseline, week 4, week 12 and week 16 and tolerance was assessed at each visit using recall questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| To establish the effects of supplementation on biomarkers: 1. HIV immune biomarkers 2. Gut activity assessed by faecal biomarkers 3. Viral load 4. CD4 counts Blood samples drawn at baseline, week 4, week 12 and week 16 and stool samples were collected at baseline and after 12 weeks. | — |
Countries
Italy
Outcome results
None listed