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NCT ID: NCT00708162 Completed - HIV Infection Clinical Trials

Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

Start date: July 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir added to a background regimen (containing a fully-active ritonavir-boosted protease inhibitor [PI/r] and a second agent) in HIV-1 infected, antiretroviral treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of antiretroviral agents. Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (elvitegravir arm), or raltegravir plus background regimen (raltegravir arm).

NCT ID: NCT00707980 Completed - Clinical trials for Major Depressive Disorder

Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the long-term efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.

NCT ID: NCT00707889 Completed - Clinical trials for Advanced Colorectal Cancer

Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer

Start date: October 2008
Phase: Phase 2
Study type: Interventional

To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on disease progression in advanced colorectal cancer.

NCT ID: NCT00707707 Completed - Breast Cancer Clinical Trials

Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer

Start date: September 15, 2008
Phase: Phase 1
Study type: Interventional

This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to be used in the randomized Phase II part. The safety and tolerability of AZD2281 in combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5 countries will be enrolled in Phase I.

NCT ID: NCT00707603 Completed - Hepatitis C Clinical Trials

Chronic Hepatitis C and Insulin Resistance

Start date: May 2006
Phase: N/A
Study type: Observational

Chronic hepatitis C (CHC) is among the commonest chronic infectious disease in Australia with >200,000 exposed persons. Amongst non-infectious chronic conditions- Type 2 diabetes, obesity and heart disease are extremely common. This study will examine the relationship between insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to CHC

NCT ID: NCT00707317 Completed - Tuberculosis Clinical Trials

T Cell Interferon-gamma Release Assay (TIGRA) in Immunocompromised Individuals

TBNET-TIPS
Start date: June 2008
Phase: N/A
Study type: Observational

Until recently, the tuberculin skin test (TST) was the only available diagnostic assay for detection of latent infection with M. tuberculosis (LTBI). Despite the low overall incidence of symptomatic tuberculosis infection in low-prevalence countries, the potential mortality and morbidity mandate constant vigilance to identify patients at risk for reactivation. Due to systemic immunosuppression, immunocompromised patients with latent M. tuberculosis infection are at increased risk of progression to active disease. This applies to patients with various causes of immunodeficiency such as HIV-infected patients, allogeneic stem cell and solid organ transplant recipients, patients with rheumatoid arthritis and patients with chronic renal failure. Therefore, current guidelines aimed at preventing tuberculosis infection in immunocompromized individuals recommend a generalized screening for evidence of latent infection to target appropriate preventative prophylaxis. At present, tuberculosis control programs exclusively rely on the tuberculin skin test to identify a latent infection in asymptomatic individuals. Recently, novel in vitro assays termed T cell interferon-gamma release assay (TIGRA) have become available that are based on the detection of interferon-gamma (IFN-gamma) production in T cells or supernatants after stimulation with highly specific antigens of M. tuberculosis. Two TIGRA are commercially available, the ELISPOT based T.SPOT.TB and the ELISA based QuantiFERON-TB Gold test (now available as an "IN-TUBE" version). The aim of the study is a prospective comparison of the two commercially available approved TIGRA (QuantiFERON-TB Gold In-Tube and T.SPOT.TB) with the established Mendel-Mantoux skin-test in immunocompromized patients (main focus on sensitivity and specificity). The study hypotheses are as follows: 1. In immunocompromised patients, the two commercially available approved TIGRA (QuantiFERON-TB Gold In-Tube and T.SPOT.TB) have increased sensitivity and specificity as compared to the established Mendel-Mantoux skin-test. 2. Results from QuantiFERON-TB Gold In-Tube and T.SPOT.TB do not differ in immunocompromised patients.

NCT ID: NCT00707304 Completed - Clinical trials for Non Small Cell Lung Cancer

Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer

FORTIS-M
Start date: November 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (NSCLC) who have been previously treated with two or more regimens.

NCT ID: NCT00706771 Completed - Renal Impairment Clinical Trials

Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study

BLISS
Start date: February 2010
Phase: Phase 2
Study type: Interventional

The investigators will determine the feasibility, safety and efficacy of intravenous sodium bicarbonate in reducing progression to overt acute renal failure in patients with the systemic inflammatory response syndrome, and low urine output or early acute renal impairment as defined by serum neutrophil gelatinase-associated lipocalin (NGAL).

NCT ID: NCT00705939 Completed - Gaucher Disease Clinical Trials

Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial

Start date: June 2008
Phase: Phase 3
Study type: Interventional

Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system. This is an extension trial to Study NCT00376168 and NCT00712348.

NCT ID: NCT00705406 Completed - Clinical trials for Acute, Uncomplicated Human Influenza

A Phase II, Multicenter, Randomized, Placebo -Controlled, Study To Evaluate The Efficacy and Safety Of Intramuscular Peramivir 600 mg In Subjects With Uncomplicated Acute Influenza

Start date: July 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether peramivir is safe and effective in the treatment of uncomplicated seasonal influenza.