- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00067587
Metabolic Abnormalities in HIV Infected and Uninfected Young Women
Prevalence of Morphologic and Metabolic Abnormalities in HIV Infected and Uninfected Young Women
Descripción general del estudio
Estado
Descripción detallada
Patients on highly active antiretroviral therapy (HAART) regimens develop potentially deleterious metabolic effects, including insulin resistance, dyslipidemia, osteopenia and osteoporosis, and hyperlactatemia. Changes in body fat distribution and bone metabolism are also documented. There is considerable evidence that protease inhibitors (PI) can induce insulin resistance and increase triglyceride and cholesterol levels. It is now also clear that both metabolic changes and fat distribution abnormalities occur in PI-naive patients treated with nucleoside analogue reverse transcriptase inhibitors (NRTIs). In addition to class specific effects, there is emerging evidence that there are differences within each class of drug in the nature and magnitude of metabolic effects. This study will examine the metabolic effects of HAART in young women.
Adolescent women aged 12 through 24 years will be recruited into each of 5 treatment strata: Stratum 1 - HIV uninfected; Stratum 2 - HIV infected but never had HAART; Stratum 3 - HIV infected on NNRTI regimen for 3 or more months and less than 2 weeks of PI therapy; Stratum 4 - HIV infected on PI regimen for 3 or more months and less than 2 weeks of NNRTI therapy; and Stratum 5 - HIV infected on NRTI-only regimen for 3 or more months and less than 2 weeks of PI or NNRTI therapy. Participants in the study will have one study visit conducted over 1 or 2 days. The study visit will include survey questionnaires, DEXA scanning, anthropometric measurements, and blood tests examining lactate, glucose, and lipid metabolism.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90027
- Children's Hopsital of Los Angeles
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San Diego, California, Estados Unidos, 92093
- University of California at San Diego
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010
- Children's National Medical Center
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Florida
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Fort Lauderdale, Florida, Estados Unidos, 33316
- Children's Diagnostic and Treatment Center
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Miami, Florida, Estados Unidos, 33124
- University of Miami
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Tampa, Florida, Estados Unidos, 33606
- University of South Florida
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Stoger Hospital of Cook County
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University
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New York
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Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center
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New York City, New York, Estados Unidos, 10128
- Mt. Sinai Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
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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
- Negative serum or urine pregnancy test if not sterilized
- Tanner Stage 4 or 5
- Accessible medical and medication history
- Willing to fast and complete clinical and laboratory evaluations
- Willingness and ability to give consent or assent with parental permission
Exclusion criteria
- Refusal to fast for 8 hours prior to specimen collection
- Unable to obtain history
- Pregnancy in last 12 months or currently pregnant
- History of anorexia or bulimia
- Type I Diabetes mellitus
- Type II Diabetes mellitus and cannot omit medication for the 48 hour period prior to laboratory specimen collection
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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HIV Negative
HIV negative subjects
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HIV Positive - NEVER had ARV therapy.
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HIV positive, on a NNRTI, non-PI regimen
HIV positive, currently on a NNRTI, non-PI regimen for at least 3 months.
Must NEVER have received a total of more than SIX months of PI-containing regimen and at least ONE year must have passed since receipt of last PI-containing regimen.
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HIV positive, on a PI, non-NNRTI regimen
HIV positive, currently on a PI, non-NNRTI regimen for at least 3 months.
Must NEVER have received a total of more than SIX months of NNRTI-containing regimen and at least ONE year must have passed since receipt of last NNRTIcontaining regimen.
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HIV positive, on a non-PI, non-NNRTI
HIV positive, currently on a non-PI, non-NNRTI containing regimen for at least 3 months.
Must NEVER have received a total of more than SIX months of PI- and/or NNRTI- containing regimen and at least ONE year must have passed since receipt of last PI- and/or NNRTI-containing regimen.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Grace Aldrovandi, MD, Children's Hospital Los Angeles
Publicaciones y enlaces útiles
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 (Actual)
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
Otros números de identificación del estudio
- ATN 021
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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