Tolerance and immunological response in human immunodeficiency virus (HIV) seropositive individuals after NR100063 supplementation

ISRCTN	ISRCTN30730587
DOI	https://doi.org/10.1186/ISRCTN30730587
Protocol serial number	100063
Sponsor	Danone Research B.V. (Netherlands)
Funder	Danone Research B.V. (Netherlands) - Centre for Specialised Nutrition

Submission date: 05/07/2010
Registration date: 29/07/2010
Last edited: 21/12/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrea Gori
Scientific

Ospedale Luigi Sacco
Via Giovanni Battista Grassi, 74
Milano
20157
Italy

Email	andrea.gori@unimib.it

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo controlled three-arm parallel study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	COPA
Study objectives	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(s)	Local ethics approval (Comitato Etico Ospedale Luigi Sacco, Milano, Italy) given on the 1st April 2005 (ref: 125/2005 3)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	NR100063
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.
Key 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.
Completion date	08/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/06/2005
Date of final enrolment	08/08/2006

Locations

Countries of recruitment

Italy

Study participating centre

Ospedale Luigi Sacco

Milano
20157
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2008		Yes	No
Results article	results	01/09/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes