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NCT ID: NCT00014937 Completed - HIV Infections Clinical Trials

Simplified Drug Regimens for HIV Patients in ACTG 388 or Patients Who Responded to A First Potent Combination Regimen

Start date: n/a
Phase: N/A
Study type: Interventional

ACTG 388 was a clinical trial that compared three- and four-drug anti-HIV drug regimens and demonstrated the effectiveness of a three-drug regimen. This study will compare the ability of two different three-drug anti-HIV drug regimens to reduce levels of HIV in the blood. The study will also evaluate whether patients discontinue the regimens because of drug side effects.

NCT ID: NCT00014950 Completed - Cystic Fibrosis Clinical Trials

Benefits and Risks of Newborn Screening for Cystic Fibrosis

Start date: n/a
Phase: N/A
Study type: Interventional

Although cystic fibrosis (CF) is the most common, life-threatening autosomal recessive genetic disorder of the white population, there are often delays in diagnosis and hence start of treatment. Advances of the past two decades have made CF screening feasible using routinely collected neonatal blood specimens and measuring an enzyme level followed by CF mutation DNA analysis. Our overall goal of the study is to see if early diagnosis of CF through neonatal screening will be medically beneficial without major risks. ''Medically beneficial'' refers to better nutrition and/or pulmonary status, whereas '' risks'' include laboratory errors, miscommunication or misunderstanding, and adverse psychosocial consequences. Specific aims include assessment of the benefits, risks, costs, quality of life, and cognitive function associated with CF neonatal screening and a better understanding of the epidemiology of CF. A comprehensive, randomized clinical trial emphasizing early diagnosis as the key variable has been underway since 1985. Nutritional status has been assessed using height and weight measurements and biochemical methods. The results have demonstrated significant benefits in the screened (early diagnosis) group. We are now focusing on the effect of early diagnosis of CF on pulmonary outcome. Pulmonary status is measured using chest radiographs, chest scans using high resolution computerized tomography, and pulmonary function tests. Other factors that we are looking at include risk factors for the acquisition of respiratory pathogens such as Pseudomonas aeruginosa, quality of life and cognitive function of children with CF who underwent early versus delayed diagnosis, as well as the cost effectiveness of screening and the costs of diagnosis and treatment of CF throughout childhood. If the questions underlying this study are answered favorably, it is likely that neonatal screening using a combination of enzyme level (immunoreactive trypsinogen) and DNA test will become the routine method for identifying new cases of CF not only in the State of Wisconsin, but throughout the country.

NCT ID: NCT00014963 Completed - Cancer Clinical Trials

Biomarkers of Benzene Exposure in Inner City Residents

Start date: n/a
Phase: N/A
Study type: Observational

This study compares air pollution exposures of residents in a South Baltimore community next to major industry with those in a comparison community with much less industry nearby. Parents and children as well as adults alone will be included. Air levels of 3 chemicals that have been found in increased amounts in the community as well as two urinary breakdown products of benzene will be measured. Participants will limit the amount of sorbate preserved foods they eat as this preservative interferes with one of the benzene breakdown products. Benzene air and urine exposure measurements will be compared in each community as well as between communities. By including children and parents we will gather exposure information on children who may be more sensitive that adults to these types of pollution. Lastly, by restricting the amount of food preserved with sorbates, we can decide if this improves the use of ttMA for people exposed to benzene from air pollution.

NCT ID: NCT00015275 Completed - Clinical trials for Substance-Related Disorders

Pathophysiological Subtyping of Abnormalities in Cocaine Dependence - 9

Start date: n/a
Phase: Phase 4
Study type: Interventional

The purpose of this study is to define pathophysiological subtypes of abnormalities in subjects with cocaine dependence.

NCT ID: NCT00015483 Completed - Cancer Clinical Trials

Hematotoxic Effects of Particulate Exposure

Start date: n/a
Phase: N/A
Study type: Observational

Hematotoxicity is caused by a number of agents such as a benzene by-product called hydroquinone and the antitumor agent doxorubicin. This is a basic research study, conducted using normal human donors, of mechanisms involved in hematotoxicity and of the protective response of human hematopoietic progenitor cells to hematotoxic agents. Tumor necrosis factor exposure protects these cells from a subsequent exposure to hematotoxic agents. The alteration of gene expression in these cells caused by tumor necrosis factor is being studied. Additionally, the tumor necrosis factor-induced biochemical pathways involved in protection of human hematopoietic progenitor cells will be studied.

NCT ID: NCT00015626 Completed - Diabetes Mellitus Clinical Trials

A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)

Start date: n/a
Phase: Phase 2
Study type: Interventional

The goal of this study is to aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood, and to prevent the subsequent progression towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical trial, we will learn more about the early manifestations of insulin resistance, its treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and in-vitro studies.

NCT ID: NCT00015652 Completed - HIV Infections Clinical Trials

Interleukin-2 (IL-2), Pegylated Interferon (PEG-IFN Alfa-2b), and Ribavirin (RBV) Treatment in Patients With Hepatitis C and HIV Coinfection

Start date: n/a
Phase: N/A
Study type: Interventional

This study will test the safety and effectiveness of a new treatment for hepatitis C (HCV) in patients who also have HIV. The usual treatment for HCV in people who are not HIV-infected is interferon-alfa (IFN) with ribavirin (RBV), an approved treatment by the Food and Drug Administration (FDA). This study will use a new, longer acting form of IFN called PEG-IFN alfa-2b. PEG-IFN alfa-2b is approved by the FDA for use in treating HCV but has not yet been approved for use with RBV. This study also will use IL-2, which is a substance that the body naturally produces. People with HIV infection usually do not make enough IL-2. IL-2 is being tested in this study to see if it will "boost" the immune system's response to HCV. The FDA has approved IL-2 for the treatment of some cancers.

NCT ID: NCT00015691 Completed - HIV Infections Clinical Trials

Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients With Insulin and Fat Abnormalities

Start date: n/a
Phase: N/A
Study type: Interventional

The purpose of this study is to see whether metformin alone, rosiglitazone alone, or metformin and rosiglitazone together will lower insulin levels in the blood and decrease fat in the abdomen or other parts of the body. Studies have shown that certain anti-HIV medications can cause a number of side effects, including high blood sugar (resulting from the body's failure to use insulin), high insulin, and excess fat build-up in the abdominal area. These side effects are known to increase the risk of heart disease. Metformin and rosiglitazone are 2 drugs that have been shown to lower insulin resistance and lessen abdominal fat in patients who are not HIV-infected. This study will investigate the use of these drugs in HIV-infected patients.

NCT ID: NCT00015704 Completed - HIV Infections Clinical Trials

Effect of Interleukin-2 on HIV Treatment Interruption

Start date: n/a
Phase: N/A
Study type: Interventional

Interleukin-2 (IL-2) helps the body make infection-fighting white blood cells, including CD4 and CD8 T cells. One HIV treatment strategy is planned treatment interruption (stopping anti-HIV drugs when CD4 count and level of virus in the blood are at certain levels). The purpose of this study is to see if IL-2 used with potent anti-HIV drugs allows for longer HIV treatment interruptions.

NCT ID: NCT00016536 Completed - HIV Infections Clinical Trials

Effects of BufferGel and PRO 2000/5 Gel in Men

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out if there are any bad effects when BufferGel or PRO 2000/5 Gel are applied to the penis of HIV-infected men. Microbicides are products to be used by women for placing into the vagina to prevent passing HIV from 1 person to another during sex. Studies have shown 2 investigational microbicides, BufferGel and PRO 2000/5 Gel, to be safe and acceptable for women and HIV-negative men. It is important to see if the side effects of these products are the same in men as those in women and to see if there is any difference in the side effects between circumcised and uncircumcised men.