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NCT ID: NCT00959894 Completed - HIV Infections Clinical Trials

Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.

NCT ID: NCT00959699 Completed - HIV Infections Clinical Trials

A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The primary objective of this trial is to compare the efficacy of boceprevir (SCH 503034) 800 mg three times a day (TID) orally (PO) in combination with peginterferon alfa-2b (PegIFN-2b) 1.5 µg/kg weekly (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (RBV) (600 mg/day to 1400 mg/day) PO to therapy with PegIFN-2b + RBV alone in adult participants coinfected with human immunodeficiency virus (HIV) and previously untreated chronic hepatitis C virus (HCV) genotype 1. Boceprevir is a potent, orally administered, novel serine protease inhibitor, specifically designed to inhibit the HCV nonstructural protein 3 (NS3) protease and, thereby, inhibit viral replication in HCV-infected host cells. The mechanism of inhibition represents a new mechanism of action compared to both interferon alfa and ribavirin. Based on previous experience with PegIFN-2b and RBV in combination with boceprevir in the HCV-monoinfected population, this combination treatment is expected to provide significant benefit to the HIV/HCV coinfected population. Given the high unmet medical need of these participants and the benefit of the addition of boceprevir to PegIFN-2b/RBV, it is important to demonstrate the safety and efficacy of boceprevir in combination with PegIFN-2b/RBV in participants coinfected with HIV/HCV. This is a randomized, multi-center trial, double-blinded for boceprevir or placebo in combination with open-label PegIFN-2b/RBV in participants coinfected with HIV and previously untreated chronic HCV (genotype 1), to be conducted in conformance with Good Clinical Practice (GCP). This trial consists of two arms, one control arm (Arm 1) and one experimental arm (Arm 2). Participants in the control arm (Arm 1) may receive boceprevir/PegIFN-2b/RBV via a crossover arm.

NCT ID: NCT00959166 Completed - HIV Infections Clinical Trials

To Assess Neuroinflammation and Neurocognitive Function in Patients With Acute Hepatitis C and Chronic HIV Co-Infection

Start date: June 2009
Phase: N/A
Study type: Interventional

This study plans to evaluate what happens to the brain in patients with HIV and early hepatitis C. The investigators will be comparing 3 groups of individuals: - Group 1: Individuals with HIV infection and acute (early) hepatitis C infection - Group 2: Individuals with HIV infection - Group 3: Healthy volunteers

NCT ID: NCT00953784 Completed - Colorectal Surgery Clinical Trials

Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

Start date: April 2007
Phase: N/A
Study type: Interventional

This is a comparison, at this VA Hospital, of standard operating room management in colorectal surgery to a more rigid management using an additional five previously tested treatments to determine if this changes the rate of post operative wound infections.

NCT ID: NCT00952796 Completed - Clinical trials for Intra-abdominal Infection

A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections

Start date: January 2009
Phase: Phase 4
Study type: Interventional

On the basis of monotherapy for intra-abdominal infection, the investigators are conducting this study to identify the difference of drug efficacy between ampicillin/sulbactam and moxifloxacin.

NCT ID: NCT00951795 Withdrawn - HIV Infections Clinical Trials

Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts

Start date: September 2009
Phase: N/A
Study type: Observational

This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate CD4+ T-cells in whole blood over the measurement range expected for the intended population. The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.

NCT ID: NCT00951015 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects

ING112276
Start date: July 30, 2009
Phase: Phase 2
Study type: Interventional

This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.

NCT ID: NCT00949130 Completed - Clinical trials for Acute Bacterial Skin and Skin Structure Infections

Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs. established treatment of acute bacterial infection in adults.

NCT ID: NCT00948441 Completed - Clinical trials for Catheter-Related Infections

Pediatric Ethanol Lock Therapy Study.

Start date: August 2008
Phase: N/A
Study type: Interventional

This study is a double-blind crossover design to compare prophylaxis with ethanol lock therapy versus placebo lock therapy (heparin). The primary outcome measure will be the number of catheter related blood stream infections (CRBSI) in each time period.

NCT ID: NCT00948142 Completed - Clinical trials for Skin Diseases, Bacterial

Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections

Start date: August 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).