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BACKGROUND Expanded access to combination antiretroviral therapy (ART) in resource-poor settings is dependent on task shifting from doctors to other health-care providers. We compared outcomes of nurse versus doctor management of ART care for HIV-infected patients. METHODS This randomised non-inferiority trial was undertaken at two South African(More)
BACKGROUND The objective of this study was to determine whether the 3-dose quadrivalent human papillomavirus (HPV) vaccine series (HPV-6, -11, -16, -18) is immunogenic and safe in young women infected with human immunodeficiency virus (HIV). METHODS We enrolled 99 women aged 16-23 years in a phase 2, open-label, multicenter trial, conducted from 2008 to(More)
BACKGROUND Neurokinin-1 receptor (NK1R) antagonists have anti-HIV activity in monocyte-derived macrophages, decrease CCR5 expression and improve natural killer cell function ex vivo. Aprepitant is a NK1R antagonist approved by FDA as an antiemetic. METHODS We conducted a phase IB randomized, placebo controlled, double masked study to evaluate the safety,(More)
We present code for the calculation and evaluation of continuously monitored stopping boundaries for use in one-arm and two-arm clinical trials. These designs were first developed for one-arm trials by Thall, Simon and Estey (TSE) (P.F. Thall, R. Simon, E.H. Estey, Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes,(More)
Background: Toll-like receptors (TLRs) are transmembrane receptors that activate cells of the innate immune systems upon recognition of pathogen-associated molecular patterns. The TLR4 is an essential component of the innate immune response to various microorganisms. We investigated the impact of TLR4 polymorphism on development of opportunistic diseases in(More)
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