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Article
Open AccessToxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV status
The phase III REMoxTB study prospectively enrolled HIV-positive (with CD4+ count > 250 cells, not on anti-retroviral therapy) and HIV-negative patients. We investigated the incidence of adverse events and cure...
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Article
Open AccessLevofloxacin versus placebo for the prevention of tuberculosis disease in child contacts of multidrug-resistant tuberculosis: study protocol for a phase III cluster randomised controlled trial (TB-CHAMP)
Multidrug-resistant (MDR) tuberculosis (TB) presents a challenge for global TB control. Treating individuals with MDR-TB infection to prevent progression to disease could be an effective public health strategy...
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Article
Open AccessToxicity associated with tuberculosis chemotherapy in the REMoxTB study
The incidence and severity of tuberculosis chemotherapy toxicity is poorly characterised. We used data available from patients in the REMoxTB trial to provide an assessment of the risks associated with the sta...
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Article
Open AccessShorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial
Tuberculosis (TB) in children is frequently paucibacillary and non-severe forms of pulmonary TB are common. Evidence for tuberculosis treatment in children is largely extrapolated from adult studies. Trials in...
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Article
Open AccessLiver toxicity associated with tuberculosis chemotherapy in the REMoxTB study
Drug-induced liver injury (DILI) is a common complication of tuberculosis treatment. We utilised data from the REMoxTB clinical trial to describe the incidence of predisposing factors and the natural history i...
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Article
Open AccessA comparison of liquid and solid culture for determining relapse and durable cure in phase III TB trials for new regimens
Tuberculosis kills more people than any other infectious disease, and new regimens are essential. The primary endpoint for confirmatory phase III trials for new regimens is a composite outcome that includes ba...
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Article
Open AccessSpot sputum samples are at least as good as early morning samples for identifying Mycobacterium tuberculosis
The use of early morning sputum samples (EMS) to diagnose tuberculosis (TB) can result in treatment delay given the need for the patient to return to the clinic with the EMS, increasing the chance of patients ...
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Article
Open AccessTuberculosis incidence is high in HIV-infected African children but is reduced by co-trimoxazole and time on antiretroviral therapy
There are few data on tuberculosis (TB) incidence in HIV-infected children on antiretroviral therapy (ART). Observational studies suggest co-trimoxazole prophylaxis may prevent TB, but there are no randomized ...
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Article
Open AccessErratum to: Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials
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Article
Open AccessLimited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials
Despite recent increased clinical trials activity, no regimen has proved able to replace the standard 6-month regimen for drug-sensitive tuberculosis. Understanding the relationship between microbiological mar...
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Article
Open AccessMicrobicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention
With 2.5 million new HIV infections per year, effective preventive methods against HIV are urgently needed, especially in sub-Saharan Africa. MDP301 is an ongoing trial of the vaginal microbicide PRO 2000/5 be...
