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Metabolic Abnormalities - HIV Infected and Uninfected Males

27 de febrero de 2017 actualizado por: University of North Carolina, Chapel Hill

Prevalence of Morphologic and Metabolic Anormalities in HIV Infected and Uninfected Young Men

To assess whether there exist significant differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV-infected and uninfected young men.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The study involves a one-time collection of health and medical history data, blood and urine specimens, and physical assessments. This study will elucidate the need for a further in-depth study to understand the pathophysiological effects of protease inhibitor (PI)-based and non-nucleoside analogue reverse transcriptase inhibitor (NNRTI)-based therapies in young men.

Tipo de estudio

De observación

Inscripción (Actual)

250

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

    • California
      • Los Angeles, California, Estados Unidos, 90054
        • Childrens Hospital of Los Angeles
      • San Diego, California, Estados Unidos, 92093
        • University of California at San Diego
      • San Francisco, California, Estados Unidos, 94143
        • University of California at San Francisco
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20010
        • Childrens Hopital National Medical Center
    • Florida
      • Fort Lauderdale, Florida, Estados Unidos, 33301
        • Children's Diagnoistic and Treatment Center
      • Miami, Florida, Estados Unidos, 33101
        • University of Miami
      • Tampa, Florida, Estados Unidos, 33606
        • University of South Florida
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • Stroger Hospital of Cook County
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Children's Hopsital of Boston
    • New York
      • Bronx, New York, Estados Unidos, 10467
        • Montefiore Medical Center
      • New York, New York, Estados Unidos, 10128
        • Mount Siani Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 02115
        • Children's Hospital of Philadelphia
      • San Juan, Puerto Rico, 00936
        • University Pediatric Hospital

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

12 años a 24 años (Niño, Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Masculino

Método de muestreo

Muestra no probabilística

Población de estudio

Approximately 250 subjects will be enrolled in the study. The number of subjects enrolled in each study group will be as follows: 50 HIV-negative subjects; 100 HIV-positive subjects who are antiretroviral therapy (ART) naïve; and two groups of up to 50 HIV-positive subjects each, one on an NNRTI-based regimen and the other on a PI-based regimen.

Descripción

Inclusion Criteria:

  • Males age 12 years and 0 days through 24 years and 364 days.
  • Tanner stage 4 or 5.
  • Accessible medical history and medications history.
  • Willingness to fast and complete all clinical evaluations and specimen collection.
  • Willingness and ability to give informed consent or assent with parental/legal guardian permission, where required.

Group 1: HIV-Negative Control Subject Specific Inclusion Criteria

  • All subjects for Group 1 will be tested for HIV-1 to confirm negativity unless they have a documented negative antibody test within the last three months of study entry.
  • Willingness and ability to give informed consent for HIV testing. Groups 2, 3, and 4: HIV-Positive Subject Specific Inclusion Criteria
  • HIV-1 infection as documented by a positive result on any of the following licensed tests at any time: any antibody test confirmed by Western blot, HIV culture, plasma HIV-1 RNA PCR >1,000 copies/ml or HIV-1 DNA PCR.
  • Horizontal HIV infection transmission (non-perinatal, non-transfusion acquired infection).
  • Group 2: Currently not on ART and must never have received ART.
  • Group 3: Currently on a NNRTI, non-PI containing regimen for three or more 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.
  • Group 4: Currently on a PI, non-NNRTI containing regimen for three or more 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 NNRTI-containing regimen.

Exclusion Criteria:

  • Transgender male to female (MTF) or female to male (FTM) youth
  • Refusal to fast for the 8 hours before collection of laboratory specimen requiring fasting.
  • Unable to obtain medical/medications history.
  • History of anorexia or bulimia.
  • Type I Diabetes Mellitus.
  • Type II Diabetes Mellitus and cannot omit diabetes medication for the 48-hour period prior to laboratory specimen collection for oral glucose tolerance test (OGTT).
  • Current use or use within the past 6 months of oxandrolone, nandrolone, oxymetholone, stanozolol, or any other synthetic anabolic/androgenic agents.
  • Current use or use within the past 6 months of pharmacologic doses of growth hormone. Physiologic growth hormone replacement therapy is permitted, as long as dosages meet the following specifications:
  • Adolescents in puberty - less than or equal to an equivalent of 0.1 mg/kg/day
  • Adolescents past puberty - less than or equal to an equivalent of 0.025 mg/kg/day
  • Current use or use within the past 6 months of pharmacologic doses of testosterone. Physiologic testosterone replacement therapy is permitted as long as dosages meet the following specifications:
  • Injection - no more than 400 mg/month of testosterone enanthate
  • Patch - no more than 5 mg/day (e.g. Testoderm, Androderm)
  • Gel in pre-packaged doses - no more than 7.5 g/day of gel (e.g. Androgel, Testim)

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-negative
HIV-infected and -uninfected males, ages 12 to 24 years, of Tanner Stage 4 or 5
HIV-positive, has never been on ART
HIV-positive, non PI containing NNRTI-based regimen
HIV-positive, currently on a non-PI-containing NNRTI-based regimen for at least 12 weeks. Must never have received a total of more than 6 months of PI-containing regimen, and at least one year must have passed since receipt of last PI-containing regimen
HIV-positive, non-NNRTI-containing PI-based regimen
HIV-positive, currently on a non-NNRTI-containing PI-based regimen for at least 12 weeks. Must never have received a total of more than 6 months of NNRTI-containing regimen, and at least one year must have passed since receipt of last NNRTI-containing regimen.

Colaboradores e Investigadores

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

Investigadores

  • Silla de estudio: Grace Aldrovandi, MD, Children's Hospital Los Angeles

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 marzo de 2006

Finalización primaria (Actual)

1 de agosto de 2007

Finalización del estudio (Actual)

1 de agosto de 2007

Fechas de registro del estudio

Enviado por primera vez

30 de noviembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

30 de noviembre de 2005

Publicado por primera vez (Estimar)

2 de diciembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de marzo de 2017

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

27 de febrero de 2017

Última verificación

1 de febrero de 2016

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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