Academic Journal
Effect of selenium supplementation on CD4+ T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial.
العنوان: | Effect of selenium supplementation on CD4+ T-cell recovery, viral suppression and morbidity of HIV-infected patients in Rwanda: a randomized controlled trial. |
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المؤلفون: | 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 |
المصدر: | AIDS, 29 (9), 1045-52 (2015) |
بيانات النشر: | Lippincott Williams & Wilkins |
سنة النشر: | 2015 |
المجموعة: | University of Liège: ORBi (Open Repository and Bibliography) |
مصطلحات موضوعية: | 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, Human health sciences, Immunology & infectious disease, Sciences de la santé humaine, Immunologie & maladie infectieuse |
الوصف: | peer reviewed ; 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. |
نوع الوثيقة: | article in journal/newspaper |
اللغة: | English |
تدمد: | 0269-9370 1473-5571 |
Relation: | urn:issn:0269-9370; urn:issn:1473-5571; https://orbi.uliege.be/handle/2268/220308; info:hdl:2268/220308; info:pmid:25870994 |
DOI: | 10.1097/QAD.0000000000000673 |
الاتاحة: | https://orbi.uliege.be/handle/2268/220308 https://orbi.uliege.be/bitstream/2268/220308/1/Rwanda%20Selenium_aids-29-1045.pdf https://doi.org/10.1097/QAD.0000000000000673 |
Rights: | open access ; http://purl.org/coar/access_right/c_abf2 ; info:eu-repo/semantics/openAccess |
رقم الانضمام: | edsbas.9B181287 |
قاعدة البيانات: | BASE |
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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. 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