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

Sahar Yousefi, Azar Hadadi, Afshin Ostovar, Behnaz Edalat Noor, Mehrnaz Rasoolinejad, Mahboobeh Haji Abdolbaghi, Hossien Khalili

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DOI: 10.4236/aid.2011.12003                

Abstract

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 5^th, 8^th, and 9^th, visits. The plasma levels of Se will be measured in the final follow-up session and compared with the baseline value.

Keywords

Supplementation, HIV, AIDS, Lymphocyte Count, Randomized Clinical Trial

Conflicts of Interest

The authors declare no conflicts of interest.

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