Reports for NATAP

1st International AIDS Society (IAS) Conference on HIV Pathogenesis and Treatment

July 7-11, 2001 Buenos Aires, Argentina

Dietary Supplements for Nelfinavir-Associated Diarrhea: acidophilus/bifidobacteria (1.2g/d) and soluble fiber (11g/d) supplements and L-Glutamine
Heiser C, French N, Gordon P, Russert M, Martin R, Kelliher G, Creative Clinical Solutions A Division Of Kelliher

These studies reported finding that In subjects with NFV-associated diarrhea, 30 grams of L-glutamine administered 3X/day over a ten day period significantly improved diarrheal severity and QOL scores; and, Probiotics (acidophilus/bifidobacteria), soluble fiber and GLN significantly reduce diarrhea.

Abstract: DIETARY SUPPLEMENTATION WITH PROBIOTICS, SOLUBLE FIBER

Background: HAART increases life expectancy for HIV patients, but is associated with side effects including diarrhea. Reducing diarrhea may allow patients to stay on effective regimens longer and improve quality of life. This study tested whether dietary changes known to reduce diarrhea in other conditions would benefit subjects receiving NFV. Methods: 20 HIV+ men on NFV with diarrhea (>2 liquid stools/d) participated in a 12-week prospective study (3:1 randomization). 16 subjects were assigned dietary supplements (S Group), 4 received standard therapy (C Group). S Group received acidophilus/bifidobacteria (1.2g/d) and soluble fiber (11g/d) supplements. If diarrhea persisted at week 4, 10g/d GLN (I assume GLN is L-glutamine) was added and adjusted up to 30g/d PRN. Supplement dosing, tolerance, diarrhea status and antidiarrheal use were assessed monthly. Results were analyzed via paired t test.

Results: Weight, CD4 and HIV RNA were unchanged in both groups after 12-weeks. Diarrhea was completely resolved in 9 of 16 S Group subjects. The number of stools/d, 3.3+1.3 (mean+SD), was reduced to 2.6+1.7(p<0.05) and diarrhea incidence declined from 2.8+1.3 to1.4+1.7(p< 0.01) for S Group. Five S Group subjects did not obtain full relief with probiotics and fiber alone, but diarrheal stools/d went from 2.4+1.7 to 0.8+0.7(p>0.1) after starting GLN. The number of stools/d for the C Group (2.3+1.9 to 3.0+1.4 (p <0.10) and the incidence of diarrhea remained unchanged. Supplements were well tolerated. In the S Group, LOP use was reduced from 3.0+4.6 to 0.6+1.4mg/d(p<0.05). Seven of 16 S Group subjects used Loperamide (LOP) at time 0, only 2 used LOP daily at week 12. Three of 4 C Group subjects took 2.2+1.8mg/d that held constant.

Conclusion: Probiotics, soluble fiber and GLN significantly reduce diarrhea for subjects receiving NFV. Improvement was also seen in subjects who were not controlling diarrhea with LOP alone. Dietary methods to treat HIV diarrhea are effective and clinically significant.

Abstract:

L-Glutamine Supplementation Improves Nelfinavir (Nfv)-Associated Diarrhea In Hiv-Infected Individuals
Huffman F, Walgren M Florida International University

Objective and Methods: The effect of 30 grams of L-glutamine intake daily on NFV-associated diarrhea, quality of life (QOL), immunologic and virologic parameters, and body composition in HIV-infected subjects was studied. Utilizing a prospective, double blind, randomized placebo-controlled metabolic crossover study, subjects were recruited from community clinics who were experiencing NFV-associated diarrhea for > 1 month.

Results: 25 subjects (92% male, 8% female; 52% Caucasian, 28% Hispanic, 12% African American), mean age 40 + 1.10 years, completed the study. Mean duration of diarrhea was 2 years. Diarrheal severity was measured on a scale from Grade 0 (no diarrhea) to Grade 4 (severe diarrhea < 7 stools/day). There was a significant difference between the placebo (1.77 + 0.28) and treatment (0.762 + 0.16) groups on mean diarrheal severity (p<0.007) when placebo was administered first. When glutamine was administered first, there was a significant crossover effect (p<0.02), with a reduction in diarrheal severity observed in the placebo group (-0.043 + 0.29). The mean change in quality of life (measured with the MOS HIV questionnaire) for the treatment group (1.48 + 0.81) was greater (demonstrating improvement) than for the placebo group (-2.19 + 0.97), who experienced a decline in MOS scores (p<0.017). There were no statistically significant differences in viral load, CD4 or body composition changes between the two groups.

Conclusions: In subjects with NFV-associated diarrhea, 30 grams of L-glutamine administered 3X/day over a ten day period significantly improved diarrheal severity and QOL scores.