- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00919724
Comparing Blood Vessel Endothelial Function in HIV-Infected People and Matched HIV-Uninfected People
A Comparison of Endothelial Function Between HIV-infected Subjects Not Receiving Antiretroviral Therapy and Matched HIV-uninfected Control Subjects
Descripción general del estudio
Estado
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
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Infectious Diseases Research Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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HIV-Infected
HIV-infected participants who are not currently receiving antiretroviral medications
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HIV-Uninfected
HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
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¿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
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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.
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Single measurement
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Samir K. Gupta, MD, MS, Indiana University School of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
Otros números de identificación del estudio
- 661
- R01HL095149 (Subvención/contrato del NIH de EE. UU.)
- HL095149
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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