Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 2 de 2
Filter
Add more filters










Database
Language
Publication year range
1.
AIDS ; 29(9): 1045-52, 2015 Jun 01.
Article in English | MEDLINE | ID: mdl-25870994

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.


Subject(s)
CD4-Positive T-Lymphocytes/immunology , Food, Formulated , HIV Infections/drug therapy , HIV/isolation & purification , Selenium/administration & dosage , Adult , CD4 Lymphocyte Count , Double-Blind Method , Female , HIV Infections/immunology , HIV Infections/virology , Humans , Longitudinal Studies , Male , Placebos/administration & dosage , Rwanda , Treatment Outcome , Viral Load
2.
Trials ; 12: 192, 2011 Aug 13.
Article in English | MEDLINE | ID: mdl-21838913

ABSTRACT

BACKGROUND: Low levels of serum selenium are associated with increased risk of mortality among HIV+ patients in East Africa. We aim to assess the effect of selenium supplementation on CD4 cell count, HIV viral load, opportunistic infections, and quality of life in HIV-infected patients in Rwanda. METHODS AND DESIGN: A 24-month, multi-centre, patient and provider-blinded, randomized, placebo-controlled clinical trial involving 300 pre-antiretroviral therapy (ART) HIV-infected patients will be carried out at two sites in Rwanda. Patients ≥ 21 years of age with documented HIV infection, CD4 cell count of 400-650 cells/mm3, and not yet on ART will be recruited. Patients will be randomized at each study site using a randomized block design to receive either the selenium micronutrient supplement or an identically appearing placebo taken once daily. The primary outcome is a composite of time from baseline to reduction of CD4 T lymphocyte count below 350 cells/mm3 (confirmed by two measures at least one week apart), or start of ART, or the emergence of a documented CDC-defined AIDS-defining illness. An intention-to-treat analysis will be conducted using stepwise regression and structural equation modeling. DISCUSSION: Micronutrient interventions that aim to improve CD4 cell count, decrease opportunistic infections, decrease HIV viral load, and ultimately delay initiation of more costly ART may be beneficial, particularly in resource-constrained settings, such as sub-Saharan Africa. Additional trials are needed to determine if micro-supplementation can delay the need for more costly ART among HIV-infected patients. If shown to be effective, selenium supplementation may be of public health importance to HIV-infected populations, particularly in sub-Saharan Africa and other resource-constrained settings.


Subject(s)
CD4 Lymphocyte Count , Dietary Supplements , HIV Infections/immunology , Quality of Life , Selenium/administration & dosage , HIV Infections/epidemiology , HIV Infections/psychology , HIV Infections/virology , Humans , Morbidity , Rwanda
SELECTION OF CITATIONS
SEARCH DETAIL
...