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Effect of selenium supplementation on CD4(+) T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial
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 conduct...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4444428/ https://www.ncbi.nlm.nih.gov/pubmed/25870994 http://dx.doi.org/10.1097/QAD.0000000000000673 |
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author | Kamwesiga, Julius Mutabazi, Vincent Kayumba, Josephine Tayari, Jean-Claude K. Uwimbabazi, Jean Claude Batanage, Gad Uwera, Grace Baziruwiha, Marcel Ntizimira, Christian Murebwayire, Antoinette Haguma, Jean Pierre Nyiransabimana, Julienne Nzabandora, Jean Bosco Nzamwita, Pascal Mukazayire, Ernestine |
author_facet | Kamwesiga, Julius Mutabazi, Vincent Kayumba, Josephine Tayari, Jean-Claude K. Uwimbabazi, Jean Claude Batanage, Gad Uwera, Grace Baziruwiha, Marcel Ntizimira, Christian Murebwayire, Antoinette Haguma, Jean Pierre Nyiransabimana, Julienne Nzabandora, Jean Bosco Nzamwita, Pascal Mukazayire, Ernestine |
author_sort | Kamwesiga, Julius |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4444428 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-44444282015-06-30 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 Tayari, Jean-Claude K. Uwimbabazi, Jean Claude Batanage, Gad Uwera, Grace Baziruwiha, Marcel Ntizimira, Christian Murebwayire, Antoinette Haguma, Jean Pierre Nyiransabimana, Julienne Nzabandora, Jean Bosco Nzamwita, Pascal Mukazayire, Ernestine AIDS Clinical Science 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. Lippincott Williams & Wilkins 2015-06-01 2015-05-20 /pmc/articles/PMC4444428/ /pubmed/25870994 http://dx.doi.org/10.1097/QAD.0000000000000673 Text en Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0 |
spellingShingle | Clinical Science Kamwesiga, Julius Mutabazi, Vincent Kayumba, Josephine Tayari, Jean-Claude K. Uwimbabazi, Jean Claude Batanage, Gad Uwera, Grace Baziruwiha, Marcel Ntizimira, Christian Murebwayire, Antoinette Haguma, Jean Pierre Nyiransabimana, Julienne Nzabandora, Jean Bosco Nzamwita, Pascal Mukazayire, Ernestine Effect of selenium supplementation on CD4(+) T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial |
title | Effect of selenium supplementation on CD4(+) T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial |
title_full | Effect of selenium supplementation on CD4(+) T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial |
title_fullStr | Effect of selenium supplementation on CD4(+) T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial |
title_full_unstemmed | Effect of selenium supplementation on CD4(+) T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial |
title_short | Effect of selenium supplementation on CD4(+) T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial |
title_sort | effect of selenium supplementation on cd4(+) t-cell recovery, viral suppression and morbidity of hiv-infected patients in rwanda: a randomized controlled trial |
topic | Clinical Science |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4444428/ https://www.ncbi.nlm.nih.gov/pubmed/25870994 http://dx.doi.org/10.1097/QAD.0000000000000673 |
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