Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine 2011-08, Vol.12 (1), p.192-192, Article 192
• Main Authors: Kamwesiga, Julius, Mutabazi, Vincent, Kayumba, Josephine, Tayari, Jean-Claude K, Smyth, Richard, Fay, Heather, Umurerwa, Alice, Baziruwiha, Marcel, Ntizimira, Christian, Murebwayire, Antoinette, Haguma, Jean Pierre, Nyiransabimana, Julienne, Habarurema, Donatille, Mukarukundo, Veneranda, Nzabandora, Jean Bosco, Nzamwita, Pascal, Mukazayire, Ernestine, Mills, Edward J, Seely, Dugald, McCready, Douglas J, Warren, Don
• Format: Article
• Language: English
• Subjects: Acquired immune deficiency syndrome; AIDS; Antifungal agents; Antiretroviral drugs; Bacterial infections; Birth control; CD4 Lymphocyte Count; Clinical trials; Diagnosis; Dietary Supplements; Disease; Drug therapy; Health aspects; Health care access; HIV; HIV infection; HIV Infections - epidemiology; HIV Infections - immunology; HIV Infections - psychology; HIV Infections - virology; Human immunodeficiency virus; Humans; Infections; Morbidity; Mortality; Nutritional status; Observational studies; Patients; Physiological aspects; Quality of Life; Questionnaires; Recovery (Medical); Rwanda; Selenium; Selenium - administration & dosage; Study Protocol; T cells; Womens health
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/1745-6215-12-192

Low levels of serum selenium are associated with increased risk of mortality among HIV+ patients in East Africa. We aim to assess the effect of selenium supplementation on CD4 cell count, HIV viral load, opportunistic infections, and quality of life in HIV-infected patients in Rwanda. A 24-month, multi-centre, patient and provider-blinded, randomized, placebo-controlled clinical trial involving 300 pre-antiretroviral therapy (ART) HIV-infected patients will be carried out at two sites in Rwanda. Patients ≥ 21 years of age with documented HIV infection, CD4 cell count of 400-650 cells/mm3, and not yet on ART will be recruited. Patients will be randomized at each study site using a randomized block design to receive either the selenium micronutrient supplement or an identically appearing placebo taken once daily. The primary outcome is a composite of time from baseline to reduction of CD4 T lymphocyte count below 350 cells/mm3 (confirmed by two measures at least one week apart), or start of ART, or the emergence of a documented CDC-defined AIDS-defining illness. An intention-to-treat analysis will be conducted using stepwise regression and structural equation modeling. Micronutrient interventions that aim to improve CD4 cell count, decrease opportunistic infections, decrease HIV viral load, and ultimately delay initiation of more costly ART may be beneficial, particularly in resource-constrained settings, such as sub-Saharan Africa. Additional trials are needed to determine if micro-supplementation can delay the need for more costly ART among HIV-infected patients. If shown to be effective, selenium supplementation may be of public health importance to HIV-infected populations, particularly in sub-Saharan Africa and other resource-constrained settings.