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NCT ID: NCT02976259 Completed - Clinical trials for HIV Infection Primary

Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection

DOLUPRIM
Start date: January 2017
Phase: Phase 3
Study type: Interventional

Sponsor: IMEA - Fondation Internationale Léon Mba C.H.U. Bichat - Claude Bernard 46, Rue Henri Huchard - 75018 PARIS Tél. : 01.40. 25. 63. 65 - Fax : 01.40.25.63.56 Coordinating investigator: Dr Caroline Lascoux Combe Hôpital Saint Louis Service Maladies Infectieuses 1 avenue Claude Vellefaux - 75010 PARIS Tél. : 01 42 49 49 73 - Fax : 01 42 49 47 43 E-mail : caroline.lascoux-combe@aphp.fr Participating country : FRANCE Primary objective : Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal plasma in patients starting a triple combination regimen with dolutegravir + tenofovir DF (TDF) + emtricitabine (FTC) at the time of PHI. Secondary objectives : - Comparison of HIV-1 RNA level in plasma (threshold 20 and 1 copies/ml) and in seminal plasma (threshold 60 copies/ml) at each visit D0, W2, W4, W8, W12, W24, W36, W48 - To assess the frequency of intermittent shedding in seminal plasma once virological suppression has been achieved and until W48 - Evolution of cellular HIV-1 DNA level in PBMC and in non-sperm cells between D0 and W48 - Comparison of dolutegravir concentration in blood plasma and seminal plasma - Study of risk factors associated with viral persistence of HIV-RNA in the seminal plasma - Analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved (i.e. at D0 and W12) Inclusion criteria : - Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a western blot profile compatible with ongoing seroconversion (incomplete western blot with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative test for HIV antibodies followed within 3 months by a positive HIV serology - Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245 mg/200 mg) initiated by the referee physician within a maximum of 15 days after diagnosis of PHI - Genotypic sensitivity to TDF, FTC and DTG - Patient with medical care insurance Exclusion criteria : - Chronic infection - Infection or co-infection with HIV-2 Study treatment : Dolutegravir and tenofovir/emtricitabine Number of subjets : 20 patients (exploratory study)

NCT ID: NCT02973282 Completed - Asthma Clinical Trials

Diagnosing Respiratory Disease in Children Using Cough Sounds

SMARTCOUGH-C
Start date: December 2016
Phase: N/A
Study type: Observational

The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in diagnosis of pneumonia and other respiratory conditions (bronchiolitis, asthma/reactive airway disease, croup, upper or lower respiratory tract infections) in infants and children. Patient's cough sounds will be recorded using a smartphone and analysed using the ResAppDx software. The ResAppDx diagnosis will be compared to radiologic diagnosis and/or clinical diagnosis. The ResAppDx diagnosis will not be provided to the clinician or patient.

NCT ID: NCT02973139 Completed - Pleural Diseases Clinical Trials

Fibrinolysis Compared to Thoracoscopy for Pleural Infection

Start date: July 14, 2017
Phase: N/A
Study type: Interventional

The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complex parapneumonic effusion (CPPE) in adults.

NCT ID: NCT02972723 Completed - Clinical trials for Chronic Hepatitis C Infection

Metformin Therapy in HCV Infection

Start date: March 2011
Phase: Phase 4
Study type: Interventional

Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease worldwide. Current therapy for HCV with interferon based therapies results in cure rates of around 5055% which leaves a significant number of patients without effective therapy. HCV induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce the response to antiHCV therapy. This finding stimulated initial studies looking at agents that may reduce insulin resistance as additional therapy in HCV infection. A study using metformin in addition to interferon and ribavirin showed a nonsignificant increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection AND demonstrable insulin resistance. The assumption was made that the potential effect of metformin was likely to be on insulin resistance and thus by modulating this enhances response. The investigators (Prof M Harris, University of Leeds) have data (currently unpublished)suggesting that metformin may have an antiviral effect independent of its effect on insulin resistance, thus raising the possibility that metformin may have a direct antiviral effect in vivo. Given that the development of specific antiHCV agents which target viral proteins such as its polymerase and protease are in trial development but have so far proved either highly toxic or are likely to have a huge cost there is considerable rationale for looking at alternative potential antiHCV agents and in this context metformin is cheap, readily available and has an excellent safety profile. This pilot study therefore addresses the question "Does metformin therapy result in a significant drop in HCV viral load in chronically infected patients?"

NCT ID: NCT02972450 Terminated - HIV-1-infection Clinical Trials

An HIV Vaccine Trial in Individuals Who Started ART During Primary or Chronic Infection

EHVAT01
Start date: February 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

EVHA T01 is an international, phase I/II, multicentre, multi-stage, double-blind study that will evaluate at least three experimental arms compared to placebo control in HIV-1 infected participants to see if one or more has a clinically relevant impact on the control of viral replication.

NCT ID: NCT02972281 Terminated - Clinical trials for Pneumococcal Infections

Systematic Search for Primary Immunodeficiency in Adults With Infections

SPIDAC
Start date: March 2015
Phase: N/A
Study type: Interventional

Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections - especially upper and lower respiratory tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in adults. The current European and US guidelines advocate screening adults for PIDs if they present recurrent benign especially upper and lower respiratory tract infections, or if they have experienced at least two severe bacterial infections and/or have a recurrent need for intravenous antibiotics. The objective of the demonstrate the interest of PIDs screening in adult patients who present such recurrent infections and/or after the first severe bacterial infection, especially when the patients do not present with known, etiologically relevant comorbidities.

NCT ID: NCT02971657 Completed - Clinical trials for Staphylococcal Infections

Bacterial Phenotype of Staphylococcus Aureus Has no Effect on Patients` Clinical Outcome in Orthopedic Device Related Bone Infections

StaphType
Start date: November 2011
Phase: N/A
Study type: Observational

This was a prospective study performed between November 2011 and September 2013. Patients with a confirmed S. aureus infection after fracture fixation or prosthetic joint infection were included. Exclusion criteria included infections involving external fixation pins, infections without any implanted hardware and culture positive patients not displaying any clinical sign of infection. The following surgical parameters were documented: affected bone or joint; type of implant; time between implantation of the device and onset of symptoms. Personal characteristics and patients`health status were also documented. Any revision surgeries involving the site of interest and all isolated pathogens were recorded throughout the course of treatment and follow-up. A follow up examination was performed an average of 23 months after discharge. Primary outcome at follow up was cure. Cure was defined by the authors as: missing local (at site of interest) or systemic signs of infection, terminated surgical and systemic therapy and restoration of joint or limb function. At the first surgical procedure after enrolment, at least four deep bone biopsies were taken from the interface between implant and affected bone. Identification and antibiotic susceptibility testing of all growth was performed. Multi-drug-resistance (MDR) was defined according to the definitions of the European Committee of Antimicrobial Susceptibility Testing (EUCAST). Biofilm formation was analysed and quantified in microtitre plate assays according to protocol of Stepanovic et al.(see references).

NCT ID: NCT02971007 Completed - Clinical trials for Candidiasis, Vulvovaginal

Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)

Start date: November 2016
Phase: Phase 2
Study type: Interventional

This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.

NCT ID: NCT02969343 Completed - Clinical trials for Venous Thromboembolism

Patient Safety Learning Laboratory: Making Acute Care More Patient-Centered

PSLL
Start date: April 2015
Phase: N/A
Study type: Interventional

The Brigham and Women's Hospital (BWH) Patient Safety Learning Laboratory (PSLL) focuses on developing health information technology (HIT) tools to engage patients, family, and professional care team members in reliable identification, assessment, and reduction of patient safety threats in real-time, before they manifest in actual harm.

NCT ID: NCT02966392 Completed - Clinical trials for Mechanical Ventilation Complication

Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections

VARI-prevent
Start date: November 1, 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether automated cuff pressure control results in a reduction in the proportion of patients developing ventilator associated respiratory infections during their stay in intensive care.