Cahn and colleagues with the international BITE study aimed to determine whether
a combination nutritional formula could reduce CD4 cells loss in people on ART.
randomized controlled trial was designed to include 800 HIV positive participants
in Argentina, Australia, Brazil, Italy, the Netherlands, Thailand, the U.K., and
the U.S. Half were randomly assigned to take the nutritional formula, known as
NR100157, for 1 year, while the other half received a control product containing
the same amount of calories and protein, but without the active ingredients.
contains several components that individually have demonstrated beneficial effects
on immune function in previous studies:
oligosaccharides: chains of simple sugars that help maintain healthy flora, or
balance of bacteria in the gut; |
cysteine: a modified amino acid that helps maintain the body's supply of glutathione,
a key antioxidant;|
colostrum: nutrient- and antibody-rich fluid produced prior to milk;|
long-chain polyunsaturated fatty acids: molecules shown to improve the integrity
of the gut, which prevents bacteria from leaking out and triggering systemic immune
including vitamins and minerals.|
study was stopped early after a planned interim analysis showed significant immunological
benefit in the NR100157 arm and no notable safety concerns.
340 participants enrolled up to that point (168 in the NR100157 arm, 172 in the
control arm) were about 80% men with an average age of 40 years. The average duration
of HIV infection was about 420 days, the median CD4 count was about 420 cells/mm3,
and viral load was about 32,000 copies/mL.
on their CD4 count, the participants did not yet need to be on ART at the time
of enrollment; if site investigators determined they needed to start, they discontinued
the nutrition study.
in the NR100157 arm lost significantly fewer CD4 cells per year than those in
the control arm (-28 vs -68 cells/mm3, respectively; expected loss for untreated
people with HIV 50-70 cells/mm3 annually).|
were no significant differences between the 2 arms with regard to CD4 percentage,
CD8 cell count, or CD4/CD8 ratio. |
viral load remained stable, and similar, in both groups.|
was high in both arms, at 85%. |
60% of participants discontinued the study early for various reasons:|
Adverse events: 30 patients in NR100157 arm vs 14 in control arm;|
Needed to start ART: 25 vs 29, respectively;
Lost to follow-up: 20 vs 17, respectively;
Withdrew consent: 17 vs 20, respectively;
Other reasons: 16 vs 9 respectively.
withdrawals for adverse events were due to gastrointestinal symptoms (mainly bloating
and gas), which were more common in the NR100157 arm.|
were no differences between arms in the rates of other types of adverse events.|
product-related serious adverse events or grade 3-4 laboratory abnormalities were
on these results, the investigators concluded, "NR10057 significantly slows
down the decline in CD4+ T-cell count in HIV-infected patients not on HAART."
findings show the potential for nutritional based strategies to become an integral
part of disease management," they added. "Further studies are needed
in order to establish clinical relevance of this approach."
Amsterdam, Netherlands; Chelsea Westminster Hosp. NHS Fndn. Trust, London, UK;
Federal Univ. of San Paulo, San Paulo, Brazil; Univ. of Milan, Milan, Italy; Utrecht
Inst. Pharma. Sc., Utrecht, Netherlands; Nutricia Advanced Med. Nutrition, Wageningen,
Netherlands; St Lukes-Roosevelt Hosp. Ctr., New York, NY; Fundación Huésped,
Buenos Aires, Argentina.
Lange, B Gazzard, R Diaz, and others. Reduced CD4+ T cell decline and immune activation
by NR100157, a specific multi-targeted nutritional intervention, in HIV-1 positive
adults not on antiretroviral therapy (BITE). 49th Interscience Conference on Antimicrobial
Agents and Chemotherapy (ICAAC 2009). San Francisco. September 12-15, 2009. Abstract