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11 February 2012
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| [ Print-friendly version ] |
| Tolerance and immunological response in human immunodeficiency virus (HIV) seropositive individuals after NR100063 supplementation |
| ISRCTN | ISRCTN30730587 |
| ClinicalTrials.gov identifier | |
| Public title | Tolerance and immunological response in human immunodeficiency virus (HIV) seropositive individuals after NR100063 supplementation |
| Scientific title | Tolerance and immunological response in human immunodeficiency virus (HIV) seropositive individuals after NR100063 supplementation: a randomised double-blind placebo-controlled three-arm parallel study |
| Acronym | COPA |
| Serial number at source | 100063 |
| Study hypothesis |
H0: No difference between Group 1 (Copa 2x dose), Group 2 (Copa 1x dose) and the control group on variable
H1: At least two of the three treatments differ from each other |
| Lay summary | Not provided at time of registration |
| Ethics approval | Local ethics approval (Comitato Etico Ospedale “Luigi Sacco”, Milano, Italy) given on the 1st April 2005 (ref: 125/2005 3) |
| Study design | Randomised double-blind placebo controlled three-arm parallel study |
| Countries of recruitment | Italy |
| Disease/condition/study domain | Human immunodeficiency virus (HIV) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/06/2005 |
| Anticipated end date | 08/08/2006 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 60 planned; 57 actual (stopped after interim analysis) |
| 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 received 30 grams of NR100063, the single dose group 15 grams of NR100063. The remainder of the product consisted of inert sugars and maltodextrin. The placebo group received 48 grams of maltodextrin. The powder was to be dissolved in water or juice, or mixed with yoghurt. Duration of study: 16 weeks |
| Primary outcome measure(s) | 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 outcome measure(s) |
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. |
| Sources of funding | Danone Research B.V. (Netherlands) - Centre for Specialised Nutrition |
| Trial website | |
| Publications |
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18094140
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21525866 |
| Contact name | Dr Andrea Gori |
| Address |
Ospedale “Luigi Sacco”
Via Giovanni Battista Grassi, 74 |
| City/town | Milano |
| Zip/Postcode | 20157 |
| Country | Italy |
| andrea.gori@unimib.it | |
| Sponsor | Danone Research B.V. (Netherlands) |
| Address |
Centre for Specialised Nutrition
Bosrandweg 20 |
| City/town | Wageningen |
| Zip/Postcode | 6704PH |
| Country | Netherlands |
| Tel | +31 (0)31 746 7800 |
| Fax | +31 (0)31 746 6500 |
| barbara.mourmans@danone.com | |
| Sponsor website: | http://www.danone.com/en/research-innovations.html |
| Date applied | 05/07/2010 |
| Last edited | 21/12/2011 |
| Date ISRCTN assigned | 29/07/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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