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Randomized Controlled Trial
. 2015 Jun 1;29(9):1045-52.
doi: 10.1097/QAD.0000000000000673.

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

Julius Kamwesiga  1 , Vincent Mutabazi, Josephine Kayumba, Jean-Claude K Tayari, Jean Claude Uwimbabazi, Gad Batanage, Grace Uwera, Marcel Baziruwiha, Christian Ntizimira, Antoinette Murebwayire, Jean Pierre Haguma, Julienne Nyiransabimana, Jean Bosco Nzabandora, Pascal Nzamwita, Ernestine Mukazayire; Rwanda Selenium Authorship Group
Affiliations
Randomized Controlled Trial

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

Julius Kamwesiga et al. AIDS. .

Abstract

Objective: To examine the effect of selenium supplementation on CD4 T-cell counts, viral suppression, and time to antiretroviral therapy (ART) initiation in ART-naive HIV-infected patients in Rwanda.

Methods: A multicenter, double-blinded, placebo-controlled, randomized clinical trial was conducted. Eligible patients were HIV-infected adults (≥21 years) who had a CD4 cell count between 400 and 650 cells/μl (ART eligibility was ≤350 cells/μl throughout the trial), and were willing to practice barrier methods of birth control. Patients were randomized to receive once-daily 200 μg selenium tablets or identical placebo. They were followed for 24 months with assessments every 6 months. Declines in CD4 cell counts were modeled using linear regressions with generalized estimating equations and effect modification, and the composite outcome (ART eligible or ART initiation) using Cox proportional-hazards regression, both conducted with intention to treat.

Results: Of the 300 participants, 149 received selenium, 202 (67%) were women, and median age was 33.5 years. The rate of CD4 depletion was reduced by 43.8% [95% confidence interval (CI) 7.8-79.8% decrease] in the treatment arm - from mean 3.97 cells/μl per month to mean 2.23 cells/μl per month. We observed 96 composite outcome events - 45 (47%) in the treatment arm. We found no treatment effect for the composite outcome (hazard ratio 1.00, 95% CI 0.66-1.54) or viral suppression (odds ratio 1.18, 95% CI 0.71-1.94). The trial was underpowered for the composite outcome due to a lower-than-anticipated event rate. Adverse events were comparable throughout.

Conclusions: This randomized clinical trial demonstrated that 24-month selenium supplementation significantly reduces the rate of CD4 cell count decline among ART-naive patients.

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Figures

Fig. 1
Fig. 1
Randomization flowchart.
Fig. 2
Fig. 2
Rate of CD4+ T-cell count decline across treatment groups.
Fig. 3
Fig. 3
Kaplan–Meier plot of time to composite outcome results.
See this image and copyright information in PMC

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