• Explain to interested patients that HIV infection attacks various targets, including the gut, leading to immune decline and poor nutritional status.
• Note that this study suggests that a nutritional supplement may blunt that HIV effect on the gut, slowing the immune system’s decline.
• Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

SAN FRANCISCO — A nutritional supplement can slow the immune system decline in HIV patients not yet treated with antiretroviral drugs, a researcher said here.

In an international, randomized, placebo-controlled trial, patients taking the supplement — dubbed NR100157 — lost fewer CD4-positive T cells over a year than those getting a placebo, according to Pedro Cahn, MD, of Fundación Huésped in Buenos Aires.

But the study was stopped early when its data monitoring committee said there could be “no gain” in continuing, Cahn said in a late-breaker presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

All told, only 340 of the planned 800 patients had been enrolled and just 143 completed the full year on either the supplement or placebo. Despite that, Cahn said, the average 40-cell benefit over the year was significant at P=0.03.

But that was challenged during the discussion of the paper by Daniel Kuritzkes, MD, a prominent HIV researcher from Brigham & Women’s Hospital in Boston, who was not part of the study.

Kuritzkes said the recommendations of data monitoring committees should be followed when a safety issue is involved, but otherwise investigators should abide by established stopping rules.

Cahn responded that the investigators felt obliged to follow the recommendation of the committee.

Specifically, he said, the committee had reasoned that because of “a statistically significant difference between groups in primary outcome and no safety concerns, there is no further gain in continuing the trial.”

Later, Kuritzkes told MedPage Today that interim data analyses generally use a much lower level of significance to determine whether a trial should he halted.

“If you look at other studies that have been stopped for efficacy, typically the P-values are very very small,” he said, in order to avoid stopping for a “spurious positive result that may not persist to the end of the trial.”

He said the positive result reported by Cahn “may or may not have held up if they had enrolled all 800 patients.”

The study was aimed at showing that the product improved gut integrity, leading to immune preservation, a decrease in oxidative stress, and better nutrition, Cahn said.

It contains a mixture of micronutrients, long-chain polyunsaturated fatty acids, bovine colostrum, prebiotic oligosaccharides, and n-acetyl cysteine — ingredients that singly have shown benefits, Cahn said.

The product comes as a powder that can be mixed with liquid or added to food.

For the study, the researchers also used a placebo powder with the same amount of calories and proteins but none of the active ingredients, he said.

Of the 168 patients in the active arm of the study, 60 finished the year-long trial, 25 started antiretroviral therapy, 30 withdrew because of adverse events, 17 simply quit, and 20 were lost to follow-up. Sixteen volunteers did not complete for other reasons.

Of the 172 patients in the control arm, 83 finished, 29 started treatment, 14 withdrew because of adverse events, 20 just quit, and 17 were lost to follow-up. Another nine did not complete for other reasons.

Most of the adverse events in those who dropped out were gastrointestinal in nature, Cahn said.

Among those who completed the study, there was no difference in viral load between the groups. But there was a significant difference in the loss of immune cells:

• On average, those in the control arm lost 68 CD4 cells per cubic millimeter of blood per year.
• Those getting the supplement lost 28 cells, on average.

The findings show the “potential for nutritional-based strategies to become an integral part of disease management,” Cahn concluded, adding that more study is needed to establish the clinical relevance of the results.

Primary source: Interscience Conference on Antimicrobial Agents and Chemotherapy

Source reference:
Lange J, 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)” ICAAC 2009; Abstract H-1230b.

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