Abstract
BackgroundLow 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.Methods and DesignA 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.DiscussionMicronutrient 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.Trial RegistrationNCT01327755
Highlights
Low levels of serum selenium are associated with increased risk of mortality among HIV+ patients in East Africa
Additional trials are needed to determine if microsupplementation can delay the need for more costly antiretroviral therapy (ART) among HIV-infected patients
If shown to be effective, selenium supplementation may be of public health importance to HIV-infected populations, in subSaharan Africa and other resource-constrained settings
Summary
Low levels of serum selenium are associated with increased risk of mortality among HIV+ patients in East Africa. There are two recent high-impact randomized clinical trials (RCTs) that have been conducted to assess the individual association of selenium supplementation on HIV viral load and CD4 cell count. The first trial, conducted in Miami by Hurwitz et al [29], found that selenium supplementation of 200 μg daily significantly suppressed the progression of HIV viral load and improved CD4 cell count after 9 months of treatment. The second trial, conducted in Tanzania by Kupka et al [30], found that selenium supplementation of 200 μg daily provided to HIVinfected pregnant women before and after pregnancy (between 12 and 27 weeks of gestation and 6 months after birth) had no significant effect on HIV viral load or CD4 cell count, but did significantly lower risk of infant death
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