Tolerance and immunological response in human immunodeficiency virus (HIV) seropositive individuals after NR100063 supplementation
| ISRCTN | ISRCTN30730587 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30730587 |
| Secondary identifying numbers | 100063 |
- 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
Scientific
Ospedale Luigi Sacco
Via Giovanni Battista Grassi, 74
Milano
20157
Italy
| andrea.gori@unimib.it |
Study information
| Study design | Randomised double-blind placebo controlled three-arm parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | NR100063 |
| Primary outcome measure | 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 study start date | 01/06/2005 |
| Completion date | 08/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 planned; 57 actual (stopped after interim analysis) |
| 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
20157
Italy
Sponsor information
Danone Research B.V. (Netherlands)
Industry
Industry
Centre for Specialised Nutrition
Bosrandweg 20
Wageningen
6704PH
Netherlands
| Phone | +31 (0)31 746 7800 |
|---|---|
| barbara.mourmans@danone.com | |
| Website | http://www.danone.com/en/research-innovations.html |
"ROR" |
https://ror.org/01c5aqt35 |
Funders
Funder type
Industry
Danone Research B.V. (Netherlands) - Centre for Specialised Nutrition
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
