Protocol of Determining the Effect of Selenium Supplementation on CD4 + T Lymphocyte Count in HIV/AIDS Patients: A Randomized Double Blind Placebo Controlled Trial

DOI: 10.4236/aid.2011.12003   PDF   HTML     3,829 Downloads   8,776 Views   Citations


Background: Acquired immune deficiency syndrome (AIDS) is believed to be both among major epidemics and a critical global health issue. The administration of antiretroviral therapy is recently proposed for all patients with CD4 + T cell count of ≤ 350/μlit in different studies The accessibility of combination therapy has been restricted due to high costs of drugs, particularly in low and middle income countries. In Iran, according to WHO, drugs were distributed among only 6% of adults and 4% - 14% of children in 2009. Moreover, new strains are created and therefore, resistance to the current medication along with a considerable risk of ART-related toxic adverse effects points out the need for more affordable, effective and safer treatments. The use of antioxidants such as Selenium (Se) has been indicated to be beneficial in these patients. Method: In a double-blind randomized placebo control trial, 100 HIV positive, HAART-receiving patients will be selected from more than 2000 individuals covered under IRCHA (Iranian Referral HIV/AIDS Research Centre). They are then randomized to receive daily Se supplement of 200 μgr elemental Se and placebo for 6 months. The baseline assessment of the patients who meet the inclusion and exclusion criteria includes doing some lab tests to determine the absolute count of CD4 + T lymphocyte and the plasma levels of Se. The incidence of opportunistic infection will be assessed during the monthly visits in the first six months of the follow-up and the one performed at the end of the 9th month. For evaluating the trend of CD4 + T cells changes, the absolute count of CD4 + T lymphocyte will be measured every 3 months in the 5th, 8th, and 9th, visits. The plasma levels of Se will be measured in the final follow-up session and compared with the baseline value.

Share and Cite:

S. Yousefi, A. Hadadi, A. Ostovar, B. Noor, M. Rasoolinejad, M. Abdolbaghi and H. Khalili, "Protocol of Determining the Effect of Selenium Supplementation on CD4 + T Lymphocyte Count in HIV/AIDS Patients: A Randomized Double Blind Placebo Controlled Trial," Advances in Infectious Diseases, Vol. 1 No. 2, 2011, pp. 20-26. doi: 10.4236/aid.2011.12003.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] Understanding HIV/AIDS, Nantional Institute of Allergy and Infectious Diseases.
[2] WHO: Global Summary of AIDS Epidemic, 2009.
[3] How HIV Causes AIDS, National Nantional Institute of Allergy and Infectious Diseases.
[4] S. M. Hammer, J. Eron Jr, P. Reiss, R. T. Schooley, M. A. Thompson, S. Walmsley, P. Cahn, M. A. Fischl, J. M. Gatell and M. S. Hirsch, “Antiretroviral Treatment of Adult HIV Infection: Recommendations of the International AIDS Society-USA Panel,” Journal of the American Medical Association, Vol. 300, No. 5, 2008, p. 555. doi:10.1001/jama.300.5.555
[6] WHO: Classification of Low- and Middle-Income Countries by Income Level, Epidemic Level, and Geographical UNAIDS, UNICEF and WHO Regions.
[7] WHO: Treated Patients in Low- and Middle-Income Countries by Income Level, Epidemic Level, and Geographical UNAIDS, UNICEF and WHO Regions.
[8] WHO: Reported Number of People Receiving Antiretroviral Therapy in Low- and Middle-Income Countries by Sex and by Age, and Estimated Number of Children Receiving and Needing Antiretroviral Therapy and Coverage Percentages, 2009.
[9] Adherence and Drug Resistance, Nantional Institute of Allergy and Infectious Diseases.
[10] L. Patrick, “Nutrients and HIV: Part One—Beta Carotene and Selenium,” Alternative Medicine Review: A Journal of Clinical Therapeutic, Vol. 4, No. 6, 1999, p. 403.
[11] K. Schwarz and C. M. Foltz, “Selenium as an Integral Part of Factor 3 against Dietary Necrotic Liver Degeneration,” Journal of the American Chemical Society, Vol. 79, No. 12, 1957, pp. 3292-3293. doi:10.1021/ja01569a087
[12] P. R. Hoffmann and M. J. Berry, “The Influence of Selenium on Immune Responses,” Molecular Nutrition & Food Research, Vol. 52, No. 11, 2008, pp. 1273-1280. doi:10.1002/mnfr.200700330
[13] M. P. Look, J. K. Rockstroh, G. S. Rao, K. A. Kreuzer, U. Spengler and T. Sauerbruch, “Serum Selenium Versus Lymphocyte Subsets and Markers of Disease Progression and Inflammatory Response in Human Immunodeficiency Virus-1 Infection,” Biological Trace Element Research, Vol. 56, No. 1, 1997, pp. 31-41. doi:10.1007/BF02778982
[14] M. K. Baum, G. Shor-Posner, S. Lai, G. Zhang, H. Lai, M. A. Fletcher, H. Sauberlich and J. B. Page, “High Risk of HIV-Related Mortality is Associated with Selenium Deficiency,” Journal of Acquired Immune Deficiency Syndromes, Vol. 15, No. 5, 1997, p. 370. doi:10.1097/00042560-199708150-00007
[15] R. Kupka, G. I. Msamanga, D. Spiegelman, S. Morris, F. Mugusi, D. J. Hunter and W. W. Fawzi, “Selenium Status is Associated with Accelerated HIV Disease Progression among HIV-1-Infected Pregnant Women in Tanzania,” The Journal of Nutrition, Vol. 134, No. 10, 2004, p. 2556.
[16] C. B. Stephensen, G. S. Marquis, S. D. Douglas, L. A. Kruzich and C. M. Wilson, “Glutathione, Glutathione Peroxidase, and Selenium Status in HIV-Positive and HIV-Negative Adolescents and Young Adults,” The American Journal of Clinical Nutrition, Vol. 85, No. 1, 2007, p. 173.
[17] G. Shor-Posner, M. J. Miguez, L. M. Pineda, A. Rodriguez, P. Ruiz, G. Castillo, X. Burbano, R. Lecusay and M. Baum, “Impact of Selenium Status on the Pathogenesis of Mycobacterial Disease in HIV-1-Infected Drug Users during the Era of Highly Active Antiretroviral Therapy,” Journal of Acquired Immune Deficiency Syndromes, Vol. 29, No. 2, 2002, p. 169.
[18] J. Constans, J. L. Pellegrin, C. Sergeant, M. Simonoff, I. Pellegrin, H. Fleury, B. Leng and C. Conri, “Serum Selenium Predicts Outcome in HIV Infection,” Journal of Acquired Immune Deficiency Syndromes, Vol. 10, No. 3, 1995, p. 392. doi:10.1097/00042560-199511000-00015
[19] H. Khalili, A. Soudbakhsh, M. Hajiabdolbaghi, S. DashtiKhavidaki, A. Poorzare, A. Saeedi and R. Sharififar, “Nutritional Status and Serum Zinc and Selenium Levels in Iranian HIV Infected Individuals,” BMC Infectious Diseases, Vol. 8, No. 1, 2008, p. 165. doi:10.1186/1471-2334-8-165
[20] M. C. Delmas-Beauviaux, E. Peuchant, A. Couchouron, J. Constans, C. Sergeant, M. Simonoff, J. L. Pellegrin, B. Leng, C. Conri and M. Clerc, “The Enzymatic Antioxidant System in Blood and Glutathione Status in Human Immunodeficiency Virus (HIV)-Infected Patients: Effects of Supplementation with Selenium or Carotene,” American Journal of Clinical Nutrition, Vol. 64, No. 1, 1996, pp. 101-107.
[21] L. Olmsted, G. N. Schrauzer, M. Flores-Arce and J. Dowd, “Selenium Supplementation of Symptomatic Human Immunodeficiency Virus Infected Patients,” Biological Trace Element Research, Vol. 20, No. 1, 1989, pp. 59-65. doi:10.1007/BF02919098
[22] P. A. Sandstrom, J. Murray, T. M. Folks and A. M. Diamond, “Antioxidant Defenses Influence HIV-1 Replication and Associated Cytopathic Effects,” Free Radical Biology and Medicine, Vol. 24, No. 9, 1998, pp. 1485-1491. doi:10.1016/S0891-5849(98)00023-9
[23] M. Kameoka, T. Kimura and K. Ikuta, “Superoxide Enhances the Spread of HIV-1 Infection by Cell-To-Cell Transmission,” FEBS Letters, Vol. 331, No. 1-2, 1993, pp. 182-186. doi:10.1016/0014-5793(93)80322-L
[24] W. Dr?ge, H. P. Eck, H. Gmünder and S. Mihm, “Requirement for Prooxidant and Antioxidant States in T Cell Mediated Immune Responses—Relevance for the Pathogenetic Mechanism of AIDS?” Journal of Molecular Medicine, Vol. 69, No. 21, 1991, pp. 1118-1122.
[25] B. E. Hurwitz, N. G. Klimas, M. M. Llabre, K. J. Maher, J. S. Skyler, M. S. Bilsker, S. McPherson-Baker, P. J. Lawrence, A. R. LaPerriere and J. M. Greeson, “HIV, Metabolic Syndrome X, Inflammation, Oxidative Stress, and Coronary Heart Disease Risk,” Cardiovascular Toxicology, Vol. 4, No. 3, 2004, pp. 303-315. doi:10.1385/CT:4:3:303
[26] E. W. Taylor, R. G. Nadimpalli and C. S. Ramanathan, “Genomic Structures of Viral Agents in Relation to the Biosynthesis of Selenoproteins,” Biological Trace Element Research, Vol. 56, No. 1, 1997, pp. 63-91. doi:10.1007/BF02778984
[27] A. Cirelli, M. Ciardi, C. De Simone, F. Sorice, R. Giordano, L. Ciaralli and S. Costantini, “Serum Selenium Concentration and Disease Progress in Patients with HIV Infection,” Clinical Biochemistry, Vol. 24, No. 2, 1991, pp. 211-214. doi:10.1016/0009-9120(91)90601-A
[28] X. Burbano, M. Miquez-Burbano, K. McCollister, G. Zhang, A. Rodriguez, P. Ruiz, R. Lecusay and G. Shor-Posner, “Impact of a Selenium Chemoprevention Clinical Trial on Hospital Admissions of HIV-Infected Participants,” HIV Clinical Trials, Vol. 3, No. 6, 2002, pp. 483-491. doi:10.1310/A7LC-7C9V-EWKF-2Y0H
[29] B. E. Hurwitz, J. R. Klaus, M. M. Llabre, A. Gonzalez, P. J. Lawrence, K. J. Maher, J. M. Greeson, M. K. Baum, G. Shor-Posner and J. S. Skyler, “Suppression of Human Immunodeficiency Virus Type 1 Viral Load with Selenium Supplementation,” Arch International Medicine, Vol. 167, 2007, pp. 148-154. doi:10.1001/archinte.167.2.148
[30] M. P. Look, J. Rockstroh, G. Rao, S. Barton, H. Lemoch, R. Kaiser, B. Kupfer, T. Sudhop, U. Spengler and T. Sauerbruch, “Sodium Selenite and N-Acetylcysteine in Antiretroviralnaive HIV-1-Infected Patients: A Randomized, Controlled Pilot Study,” European Journal of Clinical Investigation, Vol. 28, No. 5, 1998, pp. 389-397. doi:10.1046/j.1365-2362.1998.00301.x

comments powered by Disqus

Copyright © 2020 by authors and Scientific Research Publishing Inc.

Creative Commons License

This work and the related PDF file are licensed under a Creative Commons Attribution 4.0 International License.