Condition category
Infections and Infestations
Date applied
05/07/2010
Date assigned
29/07/2010
Last edited
21/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.danone.com/en/research-innovations.html

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

  1. 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.

  2. 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.

Additional files

Editorial Notes