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A Randomized Controlled Trial

Barry E. Hurwitz, PhD; Johanna R. Klaus, PhD; Maria M. Llabre, PhD; Alex Gonzalez, BA; Peter J. Lawrence, MS; Kevin J. Maher, PhD; Jeffrey M. Greeson, PhD; Marianna K. Baum, PhD; Gail Shor-Posner, PhD; Jay S. Skyler, MD; Neil Schneiderman, PhD

Arch Intern Med. 2007;167(2):148-154.

Background  Despite findings that selenium supplementation may improve immune functioning, definitive evidence of its impact on human immunodeficiency virus (HIV) disease severity is lacking.

Methods  High selenium yeast supplementation (200 µg/d) was evaluated in a double-blind, randomized, placebo-controlled trial. Intention-to-treat analyses assessed the effect on HIV-1 viral load and CD4 count after 9 months of treatment. Unless otherwise indicated, values are presented as mean ± SD.

Results  Of the 450 HIV-1–seropositive men and women who underwent screening, 262 initiated treatment and 174 completed the 9-month follow-up assessment. Mean adherence to study treatment was good (73.0% ± 24.7%) with no related adverse events. The intention-to-treat analyses indicated that the mean change () in serum selenium concentration increased significantly in the selenium-treated group and not the placebo-treated group ( = 32.2 ± 24.5 vs 0.5 ± 8.8 µg/L; P<.001), and greater levels predicted decreased HIV-1 viral load (P<.02), which predicted increased CD4 count (P<.04). Findings remained significant after covarying age, sex, ethnicity, income, education, current and past cocaine and other drug use, HIV symptom classification, antiretroviral medication regimen and adherence, time since HIV diagnosis, and hepatitis C virus coinfection. Follow-up analyses evaluating treatment effectiveness indicated that the nonresponding selenium-treated subjects whose serum selenium change was less than or equal to 26.1 µg/L displayed poor treatment adherence (56.8% ± 29.8%), HIV-1 viral load elevation ( = +0.29 ± 1.1 log₁₀ units), and decreased CD4 count ( = –25.8 ± 147.4 cells/µL). In contrast, selenium-treated subjects whose serum selenium increase was greater than 26.1 µg/L evidenced excellent treatment adherence (86.2% ± 13.0%), no change in HIV-1 viral load ( = –0.04 ± 0.7 log₁₀ units), and an increase in CD4 count ( = +27.9 ± 150.2 cells/µL).

Conclusions  Daily selenium supplementation can suppress the progression of HIV-1 viral burden and provide indirect improvement of CD4 count. The results support the use of selenium as a simple, inexpensive, and safe adjunct therapy in HIV spectrum disease.

Trial Registration  isrctn.org Identifier: ISRCTN22553118

Author Affiliations: Behavioral Medicine Research Center (Drs Hurwitz, Klaus, Llabre, Maher, Skyler, and Schneiderman and Messrs Gonzalez and Lawrence), Division of Endocrinology and Metabolism, Department of Medicine (Drs Hurwitz, Skyler, and Schneiderman), and Departments of Microbiology and Immunology (Dr Maher) and Psychiatry and Behavioral Sciences (Drs Shor-Posner and Schneiderman), University of Miami, and Robert Stempel School of Public Health, Florida International University (Dr Baum), Miami, Fla; and Departments of Psychology (Drs Hurwitz, Llabre, Greeson, and Schneiderman) and Biomedical Engineering (Drs Hurwitz and Schneiderman), University of Miami, Coral Gables, Fla.

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