Condition category
Infections and Infestations
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
06/01/2014
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

Mr Remko Hiemstra

ORCID ID

Contact details

Numico Research B.V.
PO Box 7005
Wageningen
6700 CA
Netherlands
+31 (0)317 467 991
Remko.Hiemstra@numico-research.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

BITE (Blinded nutritional study for Immunity and Tolerance Evaluation)

Study hypothesis

Improving the immunological status of Human Immunodeficiency Virus-1 (HIV-1) infected adults not on antiretroviral therapy through nutritional support.

Ethics approval

Approval received from the Medisch Ethische Commissie AMC on the 20th September 2006 (ref: Internal Numico: 100157; Ethics board: MEC 06/199).

Study design

Randomised, placebo controlled, parallel group, double blinded, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

HIV

Intervention

Intervention group:
A nutritional concept containing specific selected ingredients.

Control group:
Isocaloric nutritional product with an almost identical appearance and flavour as the investigational product though without the specific selected ingredients.

Patients will be supplied with either a nutritional test or a control product for a period of 12 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change from baseline in CD4+ T-cell count during 12 months.

Secondary outcome measures

Changes from baseline during one year in:
1. Immune markers other than CD4+ T-cell count
2. Viral load (HIV-1 RNA)

Overall trial start date

23/01/2007

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Main inclusion criteria:
1. HIV-1 positive adults who have not received (Highly Active) Anti-Retroviral Therapy ([HA]ART) in the past year and are not anticipated to start therapy within the next six months
2. HIV-1 Ribonucleic Acid (RNA) more than 5,000 copies/ml in the three months prior to screening visit
3. CD4+ T-cell count less than or equal to 800 cells/µl in the three months prior to screening visit
4. More than or equal to 18 years old

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

800

Participant exclusion criteria

Main exclusion criteria:
1. (HA)ART anticipated to be required within the next six months
2. Unintended weight loss of more than 10% in the three months prior to screening visit

Recruitment start date

23/01/2007

Recruitment end date

30/04/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Numico Research B.V.
Wageningen
6700 CA
Netherlands

Sponsor information

Organisation

Numico Research B.V. (The Netherlands)

Sponsor details

P.O. Box 7005
Wageningen
6700 CA
Netherlands

Sponsor type

Industry

Website

http://www.numico.com/en/

Funders

Funder type

Industry

Funder name

Numico Research B.V. (The Netherlands)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23511299

Publication citations

  1. Results

    Cahn P, Ruxrungtham K, Gazzard B, Diaz RS, Gori A, Kotler DP, Vriesema A, Georgiou NA, Garssen J, Clerici M, Lange JM, , The immunomodulatory nutritional intervention NR100157 reduced CD4+ T-cell decline and immune activation: a 1-year multicenter randomized controlled double-blind trial in HIV-infected persons not receiving antiretroviral therapy (The BITE Study)., Clin. Infect. Dis., 2013, 57, 1, 139-146, doi: 10.1093/cid/cit171.

Additional files

Editorial Notes