Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trialReport as inadecuate




Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 12:192

First Online: 13 August 2011Received: 10 June 2011Accepted: 13 August 2011DOI: 10.1186-1745-6215-12-192

Cite this article as: Kamwesiga, J., Mutabazi, V., Kayumba, J. et al. Trials 2011 12: 192. doi:10.1186-1745-6215-12-192

Abstract

BackgroundLow 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 DesignA 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-mm, 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-mm 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.

DiscussionMicronutrient 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.

Trial RegistrationNCT01327755

List of AbbreviationsAEadverse event, AIDS: acquired immune deficiency syndrome, ART: antiretroviral therapy, CD4: cluster of differentiation 4, DAIDS: Division of AIDS, EAE: early adverse event, FDA: US Food and Drug Administration, HIV: human immunodeficiency virus, IRB: institutional review board, ITT: intention to treat, NEC: National Ethics Committee

NRLNational Reference Laboratory, PCR: polymerase chain reaction, RNA: ribonucleic acid, SEM: structural equation modeling.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-12-192 contains supplementary material, which is available to authorized users.

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Author: Julius Kamwesiga - Vincent Mutabazi - Josephine Kayumba - Jean-Claude K Tayari - Richard Smyth - Heather Fay - Alice Umure

Source: https://link.springer.com/







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