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Comparing Blood Vessel Endothelial Function in HIV-Infected People and Matched HIV-Uninfected People

1 de julio de 2014 actualizado por: Samir K Gupta, MD, MS, Indiana University

A Comparison of Endothelial Function Between HIV-infected Subjects Not Receiving Antiretroviral Therapy and Matched HIV-uninfected Control Subjects

The blood vessels that carry blood from the heart to the rest of the body are normally capable of relaxing and constricting when needed to provide more or less blood to the body. The inability of blood vessels to relax and widen may increase the risk of heart disease and stroke. One potential cause of this inability is inflammation. Because HIV infection is associated with inflammation, it is possible that the blood vessels in people infected with HIV may not relax properly. The purpose of this study is to determine whether people infected with HIV have worse blood vessel function than people without HIV infection.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Normally the insides of blood vessels either widen or narrow in response to the need for more or less blood flow. This is a function of the endothelial cells, which are the cells that line the inner layer of blood vessels. However, in some people endothelial function is impaired, which may put them at an increased risk of heart disease and stroke. It is widely assumed that HIV-infected people not yet receiving antiretroviral medications experience more impaired endothelial function than HIV-uninfected people, possibly because of the link between HIV and inflammation. However, no rigorously controlled study has yet to be performed to verify this presumption. It is important to establish whether HIV infection itself, and not the use of antiretroviral medications, is indeed the cause of impaired endothelial function. This study will compare endothelial function in people with HIV who are not already receiving antiretroviral medications and in people without HIV. Specifically, inflammation, immune activation, endothelial activation, and metabolic measures will be compared.

This study will involve two groups of participants. The first group will consist of people with HIV who are enrolling in two other separate HIV studies (NCT00864916 and NCT00796822), one lasting 8 weeks and the other lasting 48 weeks. The second group will consist of people without HIV who are similar to the first group in terms of age, sex, smoking status, and height. All HIV-infected participants will undergo assessments during the study visits of whichever other HIV study they are enrolled in. All HIV-uninfected participants will attend a main study visit that will include the following: a review of medical records and family medical history; measurements of blood pressure, heart rate, weight, temperature, and waist and hip circumferences; blood and urine collection; and a procedure called brachial artery reactivity testing, which is a noninvasive way to measure endothelial function. Some of the HIV-uninfected participants will continue in the study so that any changes in their endothelial function can be assessed. They will attend either two additional study visits at Weeks 4 and 8, which will correspond with one of the HIV studies, or three additional study visits at Weeks 8, 24, and 48, which will correspond with the other HIV study. The additional visits will include repeat testing except for blood and urine collection.

Tipo de estudio

De observación

Inscripción (Actual)

89

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Infectious Diseases Research Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

HIV-infected people will be recruited from infectious diseases outpatient clinics of Wishard Hospital and Indiana University Hospital. They will be enrolled in one of two other HIV trials. HIV-uninfected people will be recruited from the Indianapolis general population.

Descripción

Inclusion Criteria for HIV-Infected Group:

  • Positive HIV enzyme-linked immunosorbent assay (ELISA) test with confirmatory Western Blot
  • Not currently receiving antiretroviral therapy

Inclusion Criteria for HIV-Uninfected Group:

  • Negative HIV ELISA test at screening
  • Within 10 years of age of the matched HIV-infected participant
  • Same sex and current smoking status as the matched HIV-infected participant
  • Height within 4 inches of the matched HIV-infected participant

Exclusion Criteria for All Participants:

  • Inability to complete written informed consent
  • Incarceration at the time of screening or main study visit
  • Diagnosed vascular disease (e.g., history of angina pectoris, coronary disease, peripheral vascular disease, cerebrovascular disease, aortic aneurysm, or otherwise known atherosclerotic disease)
  • Diagnosed disease or process associated with increased systemic inflammation (e.g., systemic lupus erythematosis, inflammatory bowel diseases, or other collagen vascular diseases); Note: Hepatitis B or C co-infections are not exclusionary
  • History of bleeding diathesis, gastrointestinal ulceration or bleeding, cerebrovascular aneurysm or bleeding, or retinal hemorrhage
  • Known or suspected cancer requiring systemic treatment within 6 months of screening
  • History of diabetes mellitus, as defined by the American Diabetes Association; Note: History of gestational diabetes is not exclusionary
  • History of migraine headaches
  • History of Raynaud's phenomenon
  • History of cardiac arrhythmias or cardiomyopathy
  • History of hypothyroidism or hyperthyroidism, even if treated; Note: Use of caffeinated products, except on the mornings of the study visits, is not exclusionary
  • Known allergy or intolerance to nitroglycerin
  • History of carotid bruits
  • Creatinine clearance less than 50mL/min, using a serum creatinine level measured at screening
  • Hemoglobin level greater than 9.0g/dL at screening
  • Alanine aminotransferase (ALT) level or aspartate aminotransferase (AST) greater than three times the upper limit of normal (ULN) at screening
  • Total bilirubin greater than 2.5 times ULN at screening
  • Fever, defined as a temperature greater than 38.0 C within 48 hours prior to screening
  • Received therapy for acute infection or other serious medical illness within 14 days prior to screening
  • Pregnant or breastfeeding during the course of the study
  • Hypotension, defined as systolic blood pressure less than 90mm Hg, at screening.
  • Uncontrolled hypertension
  • Receipt of anti-inflammatory agents (e.g., plaquenil, infliximab, etanercept, mycophenolate mofetil, sirolimus, tacrolimus, cyclosporine, pentoxifylline, thalidomide)
  • Receipt of investigational agents, cytotoxic chemotherapy, systemic or topical glucocorticoids (of any dose), or anabolic steroids within 28 days of screening; Note: Physiologic testosterone replacement therapy is not exclusionary
  • Receipt of lipid-lowering drugs, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), acetazolamide, anticoagulants, anticonvulsants, or thyroid replacements within 7 days prior to screening
  • Use of sildenafil, vardenafil, or tadalafil within 72 hours (before or after) of each main study visit
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
HIV-Infected
HIV-infected participants who are not currently receiving antiretroviral medications
HIV-Uninfected
HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Endothelial Function (Brachial Artery Reactivity)
Periodo de tiempo: Single measurement
The maximum change in brachial artery diameter after induction of reactive hyperemia post-release of vascular occlusion. This is a measure of the ability of the endothelium to respond appropriately to lack of tissue oxygenation distal to the point of brachial artery compression.
Single measurement

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Samir K. Gupta, MD, MS, Indiana University School of Medicine

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2009

Finalización primaria (Actual)

1 de julio de 2012

Finalización del estudio (Actual)

1 de mayo de 2013

Fechas de registro del estudio

Enviado por primera vez

11 de junio de 2009

Primero enviado que cumplió con los criterios de control de calidad

11 de junio de 2009

Publicado por primera vez (Estimar)

12 de junio de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de julio de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

1 de julio de 2014

Última verificación

1 de julio de 2014

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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