- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00001651
Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients
Studies of Lymphocyte Kinetics Using Stable Isotopes
This study will examine how quickly white blood cells called CD4 lymphocytes replicate (divide) and how long they live in both HIV-infected and non-infected people by measuring how quickly the genetic material (DNA) of cells is replicated. To do this, participants will receive infusions of glucose, a non-radioactive form of a type of sugar. Cells normally use glucose to make various products needed for cell growth and replication, including cell DNA. Measuring how much glucose cells incorporate into their DNA can provide important information about cell replication. This rate of incorporation will be examined and compared in HIV-infected people and in healthy, normal volunteers.
HIV-infected patients and non-infected healthy volunteers 18 years of age and older may be eligible for this study. Candidates will be screened with a medical history, physical examination, chest X-ray, electrocardiogram (EKG) and blood tests.
Participants will be given a continuous infusion of glucose at a dose of up to 60 grams (about 2 ounces) per day for up to 5 days. The glucose will be delivered through a catheter (thin plastic tube) placed in an arm vein. Blood samples will be collected as often as daily in the first week following the infusion and then from twice a week to once a month for up to 4 years. Alternatively, patients may undergo leukapheresis a procedure for collecting quantities of lymphocytes up to 10 times during the first month after the infusion, and possibly later as well, but no more often than once every 2 weeks. For this procedure, whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body either through the same needle or through a second needle in the other arm. Participants may be asked to receive up to four glucose infusions. There will be at least a 2-week interval between infusions. Participants who have more than three leukapheresis procedures within 3 weeks will have at least 6 weeks between infusions.
Participants will be followed periodically in the outpatient clinic for evaluation and tests.
This study may provide a better understanding of how HIV causes disease and progressive weakening of the immune system and how therapies affect immunity.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- INCLUSION CRITERIA:
FOR PATIENTS:
18 years or older.
Able to provide informed consent and willing to comply with study requirements and clinic policies.
Negative urine pregnancy test (for women of childbearing potential).
Hemoglobin greater than 10 mg/dl.
Adequate venous access in the arms for blood drawing and 5 day infusions, and lymphapheresis
Willingness to allow stored samples to be used for future studies of HIV infection and/or immunological function, and willingness to have HLA typing performed. (For previously enrolled patients, patients would be requested, but not required, to provide permission to use stored samples in the future, and to permit HLA testing
FOR HIV POSITIVE PATIENTS:
Documented HIV infection (ELISA/Western blot positive or, for acute seroconverters, PCR positive).
FOR HIV NEGATIVE PATIENTS:
Negative ELISA/Western blot.
EXCLUSION CRITERIA:
Diabetes mellitus requiring drug therapy.
Active substance abuse or prior history of substance abuse which may interfere with protocol compliance.
Psychiatric illness or disturbance which, in the assessment of the protocol team, may affect patient safety or compliance.
Significant underlying cardiac, pulmonary, renal, gastrointestinal, rheumatologic or CNS disease as detectable on routine history, physical exam, or screening laboratory studies. Patients would be excluded if they had an acute or chronic underlying medical problem that in the judgment of the principal investigator could be exacerbated by participating in the protocol or that would make it difficult for them to comply with the protocol requirements.
Pregnancy or breast-feeding.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: HIV-infected subjects
HIV-infected adults
|
[6,6-2H2]-glucose will be administered as a continuous IV infusion for one to five days.
|
Experimental: HIV-negative subjects
HIV-negative adults
|
[6,6-2H2]-glucose will be administered as a continuous IV infusion for one to five days.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Kinetics of lymphocyte turnover
Periodo de tiempo: Day 2, 5 (end of [6,6-2H2]-glucose infusion), 6, 8, 12, 16, 20, and 28. After day 28, visits will occur monthly through 6 months, then no more often than every 3 months through 2 years.
|
Cell turnover markers
|
Day 2, 5 (end of [6,6-2H2]-glucose infusion), 6, 8, 12, 16, 20, and 28. After day 28, visits will occur monthly through 6 months, then no more often than every 3 months through 2 years.
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Joseph A Kovacs, M.D., National Institutes of Health Clinical Center (CC)
Publicaciones y enlaces útiles
Publicaciones Generales
- Ho DD, Neumann AU, Perelson AS, Chen W, Leonard JM, Markowitz M. Rapid turnover of plasma virions and CD4 lymphocytes in HIV-1 infection. Nature. 1995 Jan 12;373(6510):123-6. doi: 10.1038/373123a0.
- Wolthers KC, Bea G, Wisman A, Otto SA, de Roda Husman AM, Schaft N, de Wolf F, Goudsmit J, Coutinho RA, van der Zee AG, Meyaard L, Miedema F. T cell telomere length in HIV-1 infection: no evidence for increased CD4+ T cell turnover. Science. 1996 Nov 29;274(5292):1543-7. doi: 10.1126/science.274.5292.1543.
- Hellerstein MK. Methods for measurement of fatty acid and cholesterol metabolism. Curr Opin Lipidol. 1995 Jun;6(3):172-81. doi: 10.1097/00041433-199506000-00010.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 970191
- 97-I-0191
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .
Ensayos clínicos sobre VIH
-
Icahn School of Medicine at Mount SinaiIRRASReclutamientoHemorragia Intraventricular (HIV)Estados Unidos
-
Yale UniversityTerminadoPrecocidad | Recién nacidos de muy bajo peso al nacer | Hemorragia Intraventricular (HIV) | Sangrado en el cerebroEstados Unidos
-
China Medical University HospitalDesconocidoDisplasia broncopulmonar | Bebés extremadamente prematuros | TLP grave que las terapias convencionales han fallado | Sin anomalías congénitas graves | no Hiv Severa Ni FPV QuísticaTaiwán
Ensayos clínicos sobre [6,6-2H2]-glucose
-
University Medical Center GroningenUltragenyx Pharmaceutical IncTerminadoEnfermedad por almacenamiento de glucógeno tipo IAPaíses Bajos
-
Columbia UniversityUniversity of California, BerkeleyReclutamientoResistencia a la insulina | Estado prediabético | Sobrepeso y Obesidad | Enfermedad del hígado graso no alcohólicoEstados Unidos
-
Columbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Albert...ReclutamientoObesidad | Resistencia a la insulina | Estado prediabético | Hiperinsulinemia | Enfermedad del hígado graso no alcohólicoEstados Unidos
-
University of Illinois at Urbana-ChampaignTerminado
-
University Hospital, Gentofte, CopenhagenTerminadoSensibilidad a la insulina | Trastorno del metabolismoDinamarca
-
Malte Palm Suppli, MDSection of Molecular Physiology, Department of Nutrition, Exercise and Sports... y otros colaboradoresTerminadoEnfermedad del hígado graso no alcohólico | Resistencia al glucagónDinamarca
-
Columbia UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Albert...Aún no reclutandoResistencia a la insulina | Estado prediabético | Sobrepeso y Obesidad | Enfermedad del hígado graso no alcohólicoEstados Unidos
-
Jaw-Yuan Wang, MD, PhDTerminado