Article (Scientific journals)
Effect of selenium supplementation on CD4+ T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial.
Kamwesiga, Julius; Mutabazi, Vincent; Kayumba, Josephine et al.
2015In AIDS, 29 (9), p. 1045-52
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Keywords :
Adult; CD4 Lymphocyte Count; CD4-Positive T-Lymphocytes/immunology; Double-Blind Method; Female; Food, Formulated; HIV/isolation & purification; HIV Infections/drug therapy/immunology/virology; Humans; Longitudinal Studies; Male; Placebos/administration & dosage; Rwanda; Selenium/administration & dosage; Treatment Outcome; Viral Load
Abstract :
[en] 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/mul (ART eligibility was </=350 cells/mul throughout the trial), and were willing to practice barrier methods of birth control. Patients were randomized to receive once-daily 200 mug 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/mul per month to mean 2.23 cells/mul 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.
Disciplines :
Immunology & infectious disease
Author, co-author :
Kamwesiga, Julius
Mutabazi, Vincent
Kayumba, Josephine
Tayari, Jean-Claude K.
Uwimbabazi, Jean-Claude ;  Université de Liège - ULiège > Doct. sc. bioméd. & pharma. (paysage)
Batanage, Gad
Uwera, Grace
Baziruwiha, Marcel
Ntizimira, Christian
Murebwayire, Antoinette
Haguma, Jean Pierre
Nyiransabimana, Julienne
Nzabandora, Jean Bosco
Nzamwita, Pascal
Mukazayire, Ernestine
More authors (5 more) Less
Language :
English
Title :
Effect of selenium supplementation on CD4+ T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial.
Publication date :
2015
Journal title :
AIDS
ISSN :
0269-9370
eISSN :
1473-5571
Publisher :
Lippincott Williams & Wilkins, United States
Volume :
29
Issue :
9
Pages :
1045-52
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 14 February 2018

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