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NCT ID: NCT01044654 Completed - HIV Infections Clinical Trials

Phase 1 Dose Escalation Study of Autologous T-cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases in HIV-Infected Patients

Start date: December 2009
Phase: Phase 1
Study type: Interventional

This research study is being carried out to study a new way to possibly treat HIV. This agent is called a "Zinc Finger Nuclease" or ZFN for short. ZFNs are proteins that can delete another protein named CCR5. This CCR5 protein is required for certain types of HIV (CCR5 tropic) to enter into and infect your T-cells. T cells are one of the white blood cells used by the body to fight HIV. The most important of these are called "CD4 T-cells." Some People are born without CCR5 on their T-cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 on their T-cells, and their HIV disease is less severe and is slower to cause disease (AIDS). Even with no detectable levels of HIV in the blood, HIV remains in some tissues in the body, primarily the gut tissue. HIV infects the CD4+ T-cells including in the blood and gut. The new treatment to be studied will involve removing white blood cell from the blood that contains CD4+ T-cells. The extracted CD4+ T-cells are then genetically modified by the ZFNs to be resistant to infection by HIV by removing the CCR5 gene from the surface of the CD4+ T cell where HIV enters the cell. Additional genetically modified cells are manufactured and then re-infused back into you. Researchers hope that these genetically modified cells will be resistant to infection by HIV and will be able to reproduce additional resistant CD4+ T-cells in your body. Laboratory studies have shown that when CD4+ T-cells are modified with ZFNs, HIV is prevented from killing the CD4+ T-cells. On the basis of these laboratory results, thre is the potential that ZFNs may work in humans infected with HIV and improve their immune system by allowing their CD4+ T-cells to survive longer. The purpose of this research study is to find out whether "zinc finger" modified CD4+ T-cells are safe to give to humans and find how "zinc finger" modified T-cell affects HIV.

NCT ID: NCT01043809 Completed - Infectious Disease Clinical Trials

Evaluation of a Handwashing Promotion Program in Three Countries

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

The purpose of this study is to assess whether simple, school-based handwashing promotion impacts health and hygiene knowledge among students and their families.

NCT ID: NCT01043705 Completed - Clinical trials for Cardiac Implantable Electronic Device Infection

TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD

Centurion
Start date: January 2010
Phase: N/A
Study type: Observational

The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device; either a cardiac resynchronization therapy device (CRT), or an implantable cardioverter defibrilator (ICD) and TYRX Anti-Bacterial Envelope (formerly known as "AIGISRx"), to the incidence, after replacement with an ICD or CRT and no TYRX.

NCT ID: NCT01043081 Completed - HIV Infections Clinical Trials

Sexually Transmitted Infections Among African American Women Who Have Sex With Women

WSW
Start date: February 2009
Phase: N/A
Study type: Observational

The purpose of this study is to determine the rates of sexually transmitted infections (STI) among a group of African American women who have sex with women (AA WSW). The first study hypothesis is that AA WSW are at risk for acquiring and transmitting STI, including the human immunodeficiency virus (HIV). The second study hypothesis is that AA WSW participate in multiple high-risk sexual activities that may facilitate transmission of STIs, including HIV.

NCT ID: NCT01042808 Completed - HIV Infections Clinical Trials

Isentress Re-examination Study (MK-0518-115)

Start date: May 2011
Phase: N/A
Study type: Observational

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Isentress through collecting the safety and efficacy information in usual practice according to the Re-examination Regulation for New Drugs. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

NCT ID: NCT01040091 Completed - HIV Infections Clinical Trials

Evaluation of the Cellular Pharmacology of Tenofovir and Emtricitabine According to HIV Infection Status

Start date: December 2009
Phase: Phase 1
Study type: Interventional

Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are two antiretroviral medications used for the treatment and prevention of HIV/AIDS. This study will examine how these medications are processed in the body of people who are HIV-infected, as well as in people who are HIV-uninfected.

NCT ID: NCT01039545 Terminated - Clinical trials for Urinary Tract Infections

Symptomatic Therapy of Uncomplicated Lower Urinary Tract Infections in the Ambulatory Setting.

Start date: February 2012
Phase: Phase 4
Study type: Interventional

We propose to perform a randomized controlled patient and assessor blind trial in women between the ages of 18 to 70 years with acute uncomplicated UTI to evaluate initial symptomatic treatment for 3 days with the non-steroidal anti-inflammatory drug diclofenac (experimental intervention) against immediate antibiotic treatment with norfloxacin for 3 days (control intervention). Both interventions are followed by optional delayed antibiotic treatment with single dose fosfomycin if deemed necessary by the patients. The primary objective is to determine whether initial symptomatic treatment followed by optional delayed antibiotic treatment (experimental intervention) is non-inferior to immediate antibiotic treatment (control intervention) in terms of symptom resolution.

NCT ID: NCT01038999 Completed - HIV Infection Clinical Trials

Accelerated Aging, HIV Infection, Antiretroviral Therapies

EP 45
Start date: April 2009
Phase: N/A
Study type: Observational

The main goal is to confirm, among HIV1-infected patients, data from in vitro studies showing that antiretroviral therapies induce an accelerated aging through the same mechanisms than genetic laminopathies or than "physiological " aging, that is through the synthesis and persistence of farnesylated prelamin A. The secondary goal is to measure the impact of HIV infection and of antiretroviral therapies on markers of cell ageing (proteasome, mitochondria, telomere). The perspective is to fix antiretroviral therapy side effects using the same drug combination that will be used in few weeks in Marseille to treat children suffering from progeria

NCT ID: NCT01038479 Active, not recruiting - Dental Caries Clinical Trials

Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)

MaXED
Start date: December 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if the Childsmile programme (www.child−smile.org) with the additional maternal use of xylitol is more effective at reducing dental decay in children than a Childsmile program alone. The children will be compared in the two groups at age two, to determine how the interventions affected the early colonization of mutans streptococci, an important risk factor of tooth decay. At three and at five years the investigators will also examine the amount of tooth decay in these children. Using MIDAS (Scotland's national health service dental data) records, the investigators will follow the oral health of the children until the age of 5 years. Main hypothesis: The maternal consumption of xylitol reduces early childhood caries

NCT ID: NCT01037712 Terminated - Clinical trials for Cytomegalovirus Infection

In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir

CYMEVAL
Start date: September 2009
Phase: Phase 4
Study type: Interventional

The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the neonatal viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fetal and maternal tolerance was evaluated during the pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to evaluate it in a study against placebo. Decrease the fetal viral load could make possible to decrease symptomatology neonatal in a group of infected fetuses.