Contact information
Type
Scientific
Primary contact
Dr Andrea Gori
ORCID ID
Contact details
Ospedale Luigi Sacco
Via Giovanni Battista Grassi
74
Milano
20157
Italy
andrea.gori@unimib.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
100063
Study information
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
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Human immunodeficiency virus (HIV)
Intervention
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
Intervention type
Drug
Phase
Phase II
Drug names
NR100063
Primary outcome measures
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 measures
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.
Overall trial start date
01/06/2005
Overall trial end date
08/08/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 planned; 57 actual (stopped after interim analysis)
Participant 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
Recruitment start date
01/06/2005
Recruitment end date
08/08/2006
Locations
Countries of recruitment
Italy
Trial participating centre
Ospedale Luigi Sacco
Milano
20157
Italy
Sponsor information
Organisation
Danone Research B.V. (Netherlands)
Sponsor details
Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704PH
Netherlands
+31 (0)31 746 7800
barbara.mourmans@danone.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Danone Research B.V. (Netherlands) - Centre for Specialised Nutrition
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18094140
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21525866
Publication citations
-
Results
Gori A, Tincati C, Rizzardini G, Torti C, Quirino T, Haarman M, Ben Amor K, van Schaik J, Vriesema A, Knol J, Marchetti G, Welling G, Clerici M, Early impairment of gut function and gut flora supporting a role for alteration of gastrointestinal mucosa in human immunodeficiency virus pathogenesis., J. Clin. Microbiol., 2008, 46, 2, 757-758, doi: 10.1128/JCM.01729-07.
-
Results
Gori A, Rizzardini G, Van't Land B, Amor KB, van Schaik J, Torti C, Quirino T, Tincati C, Bandera A, Knol J, Benlhassan-Chahour K, Trabattoni D, Bray D, Vriesema A, Welling G, Garssen J, Clerici M, Specific prebiotics modulate gut microbiota and immune activation in HAART-naive HIV-infected adults: results of the "COPA" pilot randomized trial., Mucosal Immunol, 2011, 4, 5, 554-563, doi: 10.1038/mi.2011.15.