9711
document
A pilot study of the safety and efficacy of supplemental arginine to enhance immune function in persons with HIV/AIDS . OBJECTIVE We collected preliminary data on the safety and efficacy of supplemental arginine to improve natural killer cell cytotoxicity in a sample of persons with human immunodeficiency virus ( HIV ) and acquired immunodeficiency syndrome ( AIDS ) . METHODS In a randomized , double-blind , placebo-controlled pilot study in an academic medical center-based infectious disease clinic , 11 clinically stable , HIV-infected adults had been treated with highly active , antiretroviral therapy and had HIV plasma RNA levels of less than 10 000 copies/mL . Participants were randomly assigned to receive 19.6 g of arginine/d ( n = 6 ) or placebo ( n = 5 ) for 14 d. Plasma HIV RNA levels , neuropsychologic functioning , and self-reported adverse events were analyzed for safety of treatment . Efficacy was measured by natural killer cell cytotoxicity . RESULTS None of the participants experienced any adverse clinical , virologic , or neuropsychologic events that necessitated withdrawal from the study . The arginine-supplemented group showed a mean natural killer cell cytotoxicity increase of 18.9 lytic units , whereas the placebo group showed an increase of 0.3 lytic units . This difference was not statistically significant ( P = 0.79 ) . CONCLUSIONS Short-term arginine supplementation is safe for persons with HIV/AIDS . Additional studies with larger samples and longer periods are warranted to determine the effects of arginine supplementation on other indices of immune function and on clinical outcomes such as intercurrent illnesses .
9712
Intervention_Pharmacological
arginine
9713
Intervention_Pharmacological
arginine
9714
Intervention_Physical
antiretroviral therapy
9715
Intervention_Pharmacological
19.6 g of arginine/d
9716
Intervention_Control
placebo
9717
Intervention_Pharmacological
arginine-supplemented
9718
Intervention_Pharmacological
arginine
9719
Outcome_Physical
Plasma HIV RNA levels
9720
Outcome_Physical
neuropsychologic functioning
9721
Outcome_Mental
,
9722
Outcome_Adverse-effects
self-reported adverse events
9723
Outcome_Other
Efficacy
9724
Outcome_Adverse-effects
adverse clinical , virologic , or neuropsychologic events
9725
Outcome_Physical
mean natural killer cell cytotoxicity
9726
Participant_Sample-size
11
9727
Participant_Age
adults