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NCT ID: NCT00402142 Completed - HIV Infections Clinical Trials

Dendritic Cell Vaccine in HIV-1 Infection

Start date: November 2006
Phase: Phase 1/Phase 2
Study type: Interventional

1. To study the efficacy of a therapeutic HIV vaccine consisting of autologous myeloid dendritic cells pulsed ex vivo with high doses of inactivated autologous HIV-1, in HIV-1 infected patients in a very early stages of the disease (CD4 > 450 x 10 6 /L). 2. To analyze the HIV-1 humoral and cellular immune responses induced by this immune-based therapy.

NCT ID: NCT00400322 Completed - Clinical trials for Glioblastoma Multiforme

Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection

Start date: August 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate if treatment of CMV infection by antiviral drug Valcyte (R) affects the clinical outcome of glioblastoma multiforme in patients with local CMV infection in tumor tissue. The investigators' hypothesis states that CMV infection promotes tumor development and disease progression and inhibits immune responses against the tumor.

NCT ID: NCT00398125 Completed - HIV-1 Infection Clinical Trials

Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults

Start date: November 2006
Phase: Phase 2
Study type: Interventional

To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults

NCT ID: NCT00398099 Completed - Pneumonia Clinical Trials

To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)

Start date: July 2005
Phase: Phase 3
Study type: Interventional

To collect clinical response data with the use of ertapenem in approved indications.

NCT ID: NCT00397735 Completed - Inflammation Clinical Trials

N-acetylcysteine in Intra-amniotic Infection/Inflammation

Start date: October 1, 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to determine if N-acetylcysteine (a potent free radical scavenger) prevents the occurrence of adverse neonatal outcomes in preterm deliveries complicated by infection associated with preterm labor or preterm premature rupture of membranes (PPROM). The working hypothesis is that in pregnancies complicated by intra-amniotic infection or inflammation, N-acetylcysteine protects the fetus by preventing the development, or decreasing the intensity and/or progression of the fetal inflammatory syndrome.

NCT ID: NCT00396578 Completed - Clinical trials for Ventilator Associated Pneumonia

Aerosolized Antibiotics and Respiratory Tract Infection in Patients on Mechanical Ventilation

Start date: August 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the effect of aerosolized antibiotics on respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized antibiotics , which achieve high drug concentrations in the airway, would more effectively treat respiratory infection, decrease the need for systemic antibiotics and decrease antibiotic resistance.

NCT ID: NCT00393120 Completed - HIV Infections Clinical Trials

Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients

Start date: October 2006
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not currently on a HAART regimen and have not received any antiretroviral agents for 3 months prior to the Screening visit. Subjects will receive study medication (INCB009471) admnistered orally or placebo once daily with food for 14 days. Clinical safety laboratories, 12-lead electrocardiograms, physical examinations and virologic assessments, including viral load, viral tropism and CD4+ cell count determinations will be performed at the Screening visit and at regularly scheduled visits throughout the study. A blood sample will also be obtained and stored to potentially determine the genotype of the CCR5 receptor. The primary objectives are: 1. Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days; 2. Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days; 3. Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days

NCT ID: NCT00391391 Completed - Influenza Clinical Trials

Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

Start date: October 2006
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: - To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. - To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

NCT ID: NCT00391053 Completed - Influenza Clinical Trials

Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly

Start date: October 2006
Phase: Phase 3
Study type: Interventional

Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at higher risk for influenza-related morbidity and mortality, represents an important unmet need. Primary Objectives: Immunogenicity: - To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing process through evaluation of the immune responses elicited by three different lots. - To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone® vaccine. Secondary Objectives: Immunogenicity: - To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone® vaccine. Safety: - To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited adverse and serious adverse events post-vaccination. - To describe clinical information on some additional defined criteria during the six months following vaccination.

NCT ID: NCT00389987 Completed - Clinical trials for Complicated Intra-Abdominal Infections

Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)

Start date: September 2001
Phase: Phase 3
Study type: Interventional

This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with respect to the clinical response in baseline microbiologically evaluable patients; and to evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.