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This is a Phase 2, two-step, open-label study of the outcome of analytic treatment interruption (ATI) on patients who started antiretroviral therapy (ART) during Fiebig Stage I of acute HIV infection (AHI), defined as detectable HIV-RNA without detectable p24 antigen or HIV IgM. The primary endpoint will be rate of sustained viral suppression, defined as HIV-1 RNA < 50 cps/ml at 24 weeks after treatment interruption. During ATI subjects will be monitored closely for safety and will have ART re-initiated if they meet predefined clinical, virological, or immunological criteria. In step I, there will be 8 subjects who undergo ATI. An interim analysis for safety will be conducted after 12 weeks. If none of the subjects maintain viral suppression at 12 weeks then no further subjects will be enrolled into the study. If at least 1 out of 8 subjects maintains viral suppression at 12 weeks then an additional 7 subjects will be enrolled in step 2. At ATI all antiretroviral drugs will be discontinued. Subjects will be monitored with clinical exam, immunological (CD4), and virological (HIV-RNA) testing at baseline and then on a fixed schedule for 24 weeks. ART will be re-initiated immediately if subjects meet any pre-defined clinical, immunological or virological safety endpoints during the monitoring period.
There is a theoretical possibility of a complete suppression of HIV viral replication, subject to the use of highly active associations of more than 25 antiretroviral drugs currently available and good treatment adherence. But a key question remains: whether it can persist viral replication low noise HAART, since several arguments suggest a subclinical escape of the virus to HAART at least in some individuals. The technique proposed in this research consists of the detection and quantification of the linear viral cDNA intra cytoplasmic, as persistent novo infection marker in order to highlight the subclinical replication active in treatment of HIV-1 and consider an optimized therapeutic management of patients. Main objective : Comparing the frequency of patients infected with HIV and treated effectively (HIV viral load undetectable plasma with conventional methods) having the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood, as cellular infection marker novo persistent, among patients with a therapeutic regimen contains or not the viral integrase inhibitor raltegravir. Secondary objectives - To evaluate the frequency of patients infected with HIV and treated effectively with the HIV DNA into the cytoplasm of their CD4 + T cells from peripheral blood - Evaluate the causes of persistent infection in de novo virological responders to treatment with ART: presence of the HIV genome encoding strains resistant to treatment ART ongoing noncompliance to treatment, type of antiretroviral therapy, CD4 nadir , pretreatment level of plasma HIV RNA, total duration of ART - Assess the impact of persistent novo infection virological responders: cell activation CD4 + and CD8 +, lack of immunological treatment response, changes in lymphocyte ratio T naïve / memory cells cells, the presence of transient increase viremia, residual viremia levels - Identify virological responders may benefit from treatment intensification
This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).
The purpose of this study is to investigate the pharmacokinetic properties in critically ill patients of a few of the most used antimicrobial drugs (amikacin, linezolid, meropenem, piperacillin/tazobactam, vancomycin). The primary objective is the identification of the clinical parameters affecting the kinetics of these drugs and the study of the contribution of extracorporeal depuration techniques to the elimination of these molecules. The secondary objective is to describe and compare the therapeutic therapies adopted in the Intensive Care Units participating in the project. For each molecule, the study will involve 300 patients admitted to Intensive Care Units. For each patient five blood samples will be collected on average, in order to measure drug plasma concentrations. Patient clinical conditions will be collected through an electronic clinical record. Finally, on the basis of those data, pharmacokinetic models will be developed to describe the evolution in time of drug plasma concentrations.
Pleural infection is a potentially serious infection of the fluid normally found around the lung and current evidence suggests its incidence is increasing in both adult and paediatric populations. Identification of bacterial pathogens causing pleural infection is of paramount importance in the clinical care of patients are currently, only 40% of patients have a laboratory confirmed microbiological diagnosis for their pleural infection. An unclear diagnosis can be due to various reasons such as a small sample volume therefore the aim of the AUDIO study is to ascertain the capacity of pleural biopsies in improving the microbiological yield of pleural infection. Currently, there are no well validated methods for identifying patients presenting with pleural infection on the basis of initial ultrasound imaging. The AUDIO study will define the role of baseline thoracic ultrasound in predicting the radiographic, clinical and surgical outcomes of patients with pleural infection. The AUDIO study aims to recruit 50 patients from 2 centres with specific pleural expertise and these patients will be followed up over a 12 month period. Investigators hope that through the information gathered from ultrasound imaging and pleural biopsies, it will aid physicians' clinical and therapeutic decision making when treating patients with pleural infection.
The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy. Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.
Municipal water networks within industrialized countries typically rely on centralized treatment to manage piped water quality. Optimal water quality at the tap, however, requires well-maintained piped distribution networks, and performs best when piped systems are fully pressurized. In low-income cities such as Dhaka, water distribution networks are inadequately maintained and typically supply intermittent service; as such, they are vulnerable to recontamination during negative pressure events. Among populations accessing these types of improved water sources in urban settings (e.g. shared taps), it is unknown if consistent treatment to provide chlorinated water at the point of collection would have a significant health benefit. Furthermore, almost all previous studies of water treatment interventions in low-income countries have been unblinded with self-reported diarrhea as the main outcome, casting doubt that reported impacts of water disinfection on diarrhea are not due entirely to social desirability bias. Stanford University in collaboration with icddr,b will conduct a randomized evaluation to assess the impact on access to automatically chlorinated water on water quality and child health.
This study aimed to analysis the characteristics of MERS transmission and the effect of our institutional personal protective equipment on the controlling the MERS at a tertiary Korean Hospital.