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HIV Infections clinical trials

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NCT ID: NCT00843713 Completed - HIV Infections Clinical Trials

Effect of Raltegravir on Endothelial Function in HIV-Infected Patients

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

Recent studies suggest that HIV patients are at increased risk for cardiovascular events; however, the mechanisms underlying this increased risk remain unclear. Our group was one of the first to demonstrate that HIV infection is independently associated with accelerated atherosclerosis, as measured by carotid artery-intima media thickness (IMT), and that HIV-associated inflammation may be driving this accelerated atherosclerosis. The mechanism by which HIV disease independent of any drug-specific toxicity increases the risk of cardiovascular disease during HAART is not known. We hypothesize that even well controlled HIV infection is independently associated with cardiovascular risk and that further decreasing HIV-associated inflammation adding newer antiretroviral agents will also decrease cardiovascular risk. We will perform a small clinical trial of approximately 50 HIV-infected patients each to study the relationship between HIV infection, inflammation, thrombosis, atherogenic lipoproteins, and measures of atherosclerosis. We propose the following specific aims: Aim 1: To determine the influence of traditional and novel markers of inflammation on endothelial function and IMT progression; Aim 2: To determine if "intensification" with raltegravir in subjects on long-term antiretroviral therapy with clinically undetectable HIV RNA levels will improve endothelial function, and to determine if this effect is mediated by alterations in inflammatory markers, lipoproteins and/or thrombotic factors. For Aim 2, subjects from 2 randomized, double-blind, placebo-controlled raltegravir intensification studies will be asked to co-enroll in this cardiovascular study.

NCT ID: NCT00843661 Recruiting - HIV Infections Clinical Trials

Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

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

- The aim of the study is to compare the effects of coadministration of ezetimibe 10 mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected patients treated with protease inhibitors. - Single-centre, open, randomized, controlled, prospective pilot study. - 60 patients will be enrolled in order to reach the target of 50 patients evaluable at the end of the study. The patients will be randomly assigned to a 6-month treatment with ezetimibe+fenofibrate or with pravastatin.The visit will be every month.

NCT ID: NCT00842634 Completed - HIV Infections Clinical Trials

Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 for HIV

Zinc-Finger
Start date: January 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 common types of HIV (CCR5 tropic) to enter into and infect T-cells. T-cells are one of the white blood cells used by the body to fight HIV. The most important T-cells are those 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). In order to delete the CCR5 protein on the T cells, this study will isolate large numbers of T-cells from subjects, and then deliver the ZFNs using a delivery vehicle called a viral vector. The viral vector used in this study is called an adenoviral vector. The vector is added to the cells at the beginning of the manufacture process and the ZFNs knock out the CCR5 protein. By the time T-cells are returned to subjects, there is minimal adenovirus or ZFN present. The removal of the CCR5 protein on the T-cells subjects receive, however, is permanent. The purpose of this research study is to find out whether "zinc finger" modified T-cells are 1. safe to give to humans and 2. find how "zinc finger" modified T cell affects HIV This is an experimental study. Laboratory studies have shown that when CD4 T-cells are modified with "zinc fingers", HIV is prevented from killing the CD4 T cells. On the basis of these laboratory results, there is the potential that "zinc fingers" may work in humans infected with HIV and improve their immune system by allowing their CD4 T-cells to survive longer (HIV usually kills T cells it infects). All subjects who receive ZFN Modified CD4+T cells will enroll in a Long Term, Follow-up study to monitor subjects. Subjects will be followed every 3 months for four years. If the ZFN Modified CD4+T cells are no longer found in the blood after four years, then subjects will be contacted yearly for the next 6 years. If the ZFN Modified CD4+T cells are found in the blood at year four, then the subjects will continue to be seen once a year until the ZFN Modified CD4+T cells are no longer found in the blood for a maximum of 10 years.

NCT ID: NCT00841711 Completed - HIV Infections Clinical Trials

Transitions: Linkages From Jail To Community

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

TRANSITIONS, a novel jail-release program for People Living with HIV/AIDS (PLWHA), will use evidence-based interventions and adapt them to create a comprehensive transitional program in Waterbury and New Haven County, Connecticut. Evidence-based interventions will include, but not be limited to, enhanced rapid HIV testing within the New Haven Community Correctional Center (NHCCC, local jail), intensive case management, continuity of buprenorphine treatment from the jail to the community setting and a novel Money Management (MM) program. The HIV in Prisons Program and the Community Health Care Van (CHCV) at the Yale University AIDS Program, in collaboration with the Connecticut Department of Correction and the Waterbury Hospital Infectious Diseases Clinic, propose to expand the availability of opiate substitution treatment and to enhance clinical and social services for PLWHA, who are transitioning from the jail to the community setting. As part of Transitions, we will develop a model Money Management program that we have used in community settings to improve health outcomes for socially and medically marginalized populations and adapt it for a jail-release program. The Transitions program will incorporate these elements into a combined intervention and will result in a clinical trial to compare the additional contribution of a money management program.

NCT ID: NCT00841477 Completed - HIV Infection Clinical Trials

An Hepatitis B Vaccine Model for HIV Vaccine Trials in Drug Users

Start date: January 2004
Phase: Phase 3
Study type: Interventional

The goal of the proposed study is to use the HBV vaccine as a model for a future HIV vaccine trial, examining the efficacy of community-based outreach intervention as well as an accelerated vaccine schedule as a method for increasing acceptance/adherence with HBV vaccination protocols among not-in-treatment drug users. This study will also examine the effect of HBV vaccination coupled with community-based outreach intervention on reducing the incidence of HIV, HBV and HCV infections and the frequency of needle use and sexual risk behaviors related to these viral transmissions. A secondary purpose will be to assess the antibody response after HBV vaccination as a measurement of immunological response in drug users.

NCT ID: NCT00841360 Completed - HIV Infections Clinical Trials

ID and Testing Via Friendship Networks

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

This is a pilot study with a cross-sectional research design to recruit Hispanic/Latina and African American adolescent and young adult women, aged 13-24 years to serve as index recruiters, who will in turn recruit members of her female friendship network, aged 13 years and older to undergo HIV screening. This approach seeks to identify new HIV infections in the target population.

NCT ID: NCT00840905 Completed - HIV Infections Clinical Trials

A Study to Examine the Human Papillomavirus Types Exposure in Women From Southern Africa and Brasil

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

This is a study to determine what Human Papillomavirus HIV seropositive women in Botswana, South Africa and Brasil have been exposed to during their life. The Human Papillomavirus causes cervical cancer. Different types are more likely to lead to cancer than other types. A vaccine has been made to fight infection against HPV 16 and 18 which has been shown to cause cervical cancer in America and Europe. What HPV type cause cancer in other countries is not as well studied. Hypothesis HPV serology will demonstrate that exposure to each HPV type in Gardisil (6,11,16,18) will be <50% in HIV seropositive women in resource limited countries.

NCT ID: NCT00840762 Recruiting - HIV Infections Clinical Trials

A Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication

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

The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to those provided by local expert review. The investigators propose that clinic patients of the Ruth M. Rothstein CORE Center who are having genotypic testing performed will be randomized in a 1:1 fashion to local expert review and to Virco®TYPE HIV-1. Results of either method will be shared with primary HIV care providers. Patient outcomes will be reviewed at a time point equal to or greater than 2 months and 6 months following the change in antiretroviral medications following the testing

NCT ID: NCT00840658 Completed - HIV Infections Clinical Trials

Behavioral Intervention to Reduce Sexual and Injection Risks Among Female Sex Workers Who Also Inject Drugs in Mexico

FSW-IDU
Start date: October 2008
Phase: Phase 2
Study type: Interventional

The investigators propose a highly efficient four-arm (factorial) trial to simultaneously test the efficacy of two behavioral interventions aimed at: - increasing condom use in the context of ongoing drug use and - decreasing needle and paraphernalia sharing among female sex workers who also inject drugs in two Mexican-U.S. border cities: Tijuana and Ciudad Juarez.

NCT ID: NCT00838292 Completed - HIV Infections Clinical Trials

Study of Impacts of Food Supplementation on Malnourished HIV-Infected Adults in Kenya

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

The purpose of the study is to test whether food supplementation of malnourished HIV-infected adults (both pre-ART and ART) in resource constrained settings improves their nutritional status, clinical status, effectiveness of treatment, quality of life, functioning, and survival.