title: Effect of selenium supplementation on CD4+ T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial.
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.
authors: aRwanda Biomedical Centre, Kigali, Rwanda, Kinyinya and Kibagabaga ART Sites bRwanda Selenium Supplementation Clinical Trial Team, Kigali, Rwanda.
authors: Julius
authors: J
authors: Kamwesiga
authors: Vincent
authors: V
authors: Mutabazi
authors: Josephine
authors: J
authors: Kayumba
authors: Jean-Claude K
authors: JC
authors: Tayari
authors: Jean Claude
authors: JC
authors: Uwimbabazi
authors: Gad
authors: G
authors: Batanage
authors: Grace
authors: G
authors: Uwera
authors: Marcel
authors: M
authors: Baziruwiha
authors: Christian
authors: C
authors: Ntizimira
authors: Antoinette
authors: A
authors: Murebwayire
authors: Jean Pierre
authors: JP
authors: Haguma
authors: Julienne
authors: J
authors: Nyiransabimana
authors: Jean Bosco
authors: JB
authors: Nzabandora
authors: Pascal
authors: P
authors: Nzamwita
authors: Ernestine
authors: E
authors: Mukazayire
mesh_terms: D000328:Adult; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D005526:Food, Formulated; D006678:HIV / Q000302:isolation & purification*; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D012432:Rwanda; D012643:Selenium / Q000008:administration & dosage*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D010919:Placebos; D012643:Selenium