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Gut-Shielding Mix Slows CD4 Drop in People Not Taking Antiretrovirals
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49th ICAAC (Interscience Conference on Antimicrobial Agents and Chemotherapy), September 12-15, 2009, San Francisco
From Jules: I find the use of this product based on the data questionable.
Mark Mascolini
A nutritional agent taken by HIV-infected antiretroviral-naive adults significantly slowed yearly decline in CD4 count in an international randomized trial [1]. But a question arose about whether the trial should have been stopped so soon.
NR100157 aims to promote gut integrity in people with HIV and thereby slow immune deterioration, decrease oxidative stress, and improve nutritional status. The formula includes:
· Oligosaccharides: simple sugars that promote healthy gut bacteria and suppress harmful bacteria while decreasing systemic CD4 activation
· n3-PUFAs: polyunsaturated fatty acids that decrease inflammation and gut permeability
· Bovine colostrums: nutrient-rich milk that improves gut integrity
· N-acetyl cysteine (NAC): an amino acid that improves glutathione status
· A vitamin/mineral mix to suppress antioxidants and prevent micronutrient deficiencies
BITE, an international double-blind placebo-controlled trial, compared NR100157 with placebo in 340 HIV-infected adults who had not begun antiretroviral therapy. The primary endpoint was CD4-cell change from baseline. CD4 counts typically drop by 50 to 70 cells yearly in untreated people.
The trial took place in Argentina, Australia, Brazil, Italy, the Netherlands, Thailand, the UK, and the United States. Although BITE investigators aimed to enroll 400 people in each arm, the trial ended after they signed up 168 people taking NR100157 and 172 taking placebo. About 80% in each group were men, and study participants had a median age of 39 in the active treatment group and 40 in the control group. Most people had been infected with HIV for more than a year. CD4 counts averaged 425 in the NR100157 group and 413 in the control group, while viral loads averaged 4.47 log and 4.53 log (about 30,000 to 35,000 copies).
Only 60 people completed treatment in the NR100157 arm, compared with 83 in the placebo arm. Twenty-five people taking NR100157 and 29 taking placebo dropped out because they had to start antiretroviral therapy. The biggest difference in reasons for quitting the trial involved adverse events--30 in the NR100157 group versus 14 in the placebo group. Most of these problems were nonthreatening but discommoding bloating and flatulence. Even so, the investigators rated adherence above 95% in both treatment groups.
The data and safety monitoring board (DSMB) recommended stopping BITE early because of a significant difference in CD4 decline between groups and lack of safety concerns. An intention-to-treat analysis at 52 weeks showed a significantly slower annual average CD4-cell drop in the NR100157 group, 28 versus 68 cells/mm(3) with placebo (P = 0.030). Change in viral load did not differ significantly between the two groups (P = 0.81). NR100157 had no impact on CD8 count, CD4-to-CD8 ratio, or CD4%. The researchers recorded no cases of clinical progression in either arm.
In a question-and-answer session after Argentina's Pedro Cahn presented these findings, Harvard's Daniel Kuritzkes claimed to be "stunned" that the DSMB would stop the trial of an apparently safe agent when the statistical difference between treatment arms reached only 0.03. He also questioned the investigators' decision to take the DSMB's advice. Kuritzkes felt stopping a trial at such a low level of significance leaves open the possibility of bias toward a positive finding.
Reference
1. Lange J, Gazzard B, Diaz R, et al. 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 ICAAC (Interscience Conference on Antimicrobial Agents and Chemotherapy). September 12-15, 2009. San Francisco. Abstract H-1230b.
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