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Problems Associated With the Use of Anti-HIV Drugs in HIV-Infected Pregnant Women

3 de agosto de 2006 actualizado por: National Institute of Allergy and Infectious Diseases (NIAID)

Evaluation of Metabolic Complications Associated With Antiretroviral Medications in HIV-1-Infected Pregnant Women

The purpose of this study is to find out if HIV-infected pregnant women who take protease inhibitors (PIs) are more likely to have blood sugar problems than those who do not take PIs.

HIV-infected people generally are treated with a combination of different types of anti-HIV drugs, 1 of which is usually a PI. The same holds true for pregnant women, but not much is known about the use of these drugs in pregnancy. Blood sugar and liver problems caused by anti-HIV drugs in nonpregnant patients are well known but their effects in pregnancy are not. Also, certain physical changes brought about by pregnancy may affect the way drugs are handled in the body. There remains a need for further study into the use of anti-HIV drugs during pregnancy and their effect on the safety of the mother and baby.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The dramatic impact of potent combination antiretroviral therapies on the course of HIV disease has made the use of PIs routine in the care of HIV-1-infected individuals. Combination therapy likewise has become the standard of care in pregnant individuals, even though information on use of these drugs during human pregnancy is limited. There are no published prospective evaluations of toxicities experienced by pregnant women on PI-containing antiretroviral regimens, despite findings of metabolic disturbances of glucose, fatty acids, and cholesterol, as well as lactic acidosis/hepatic steatosis in nonpregnant individuals treated with antiretrovirals. Gastrointestinal (GI) side effects also are well documented in nonpregnant individuals treated with PIs, but have not been systematically evaluated in pregnancy. In addition, the physiologic changes brought about by pregnancy may influence the pharmacokinetics, safety, and side effects of antiretroviral drugs. There remains a need for further evaluation of the use of antiretrovirals during pregnancy and their impact on maternal, fetal, and infant safety.

Patients are stratified according to whether or not they are on a PI-containing antiretroviral regimen and the number of weeks of gestation (26 weeks or less versus greater than 26 weeks). Patients are followed at 8-week intervals from the time of entry until delivery or pregnancy termination, with an additional visit at 12 weeks after delivery or pregnancy termination. All infants born to study participants are evaluated at the time of delivery (anthropometrics and HIV DNA PCR) and are seen again at the mothers' 12-week post-delivery visit. Glucose tolerance testing and other metabolic studies are performed serially during pregnancy and again postpartum. This is an observational study and drugs are not supplied. Patients receiving antiretroviral therapy must obtain their own medications.

Tipo de estudio

De observación

Inscripción

160

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

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • Univ of Alabama at Birmingham - Pediatric
    • California
      • Los Angeles, California, Estados Unidos, 90033
        • Los Angeles County - USC Med Ctr
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06504
        • Yale University School Of Medicine
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20060
        • Howard Univ Hosp
    • Florida
      • Jacksonville, Florida, Estados Unidos, 32209
        • Univ of Florida Health Science Ctr / Pediatrics
      • Miami, Florida, Estados Unidos, 33161
        • Univ of Miami (Pediatric)
    • Georgia
      • Columbus, Georgia, Estados Unidos, 31901
        • The Med Ctr Inc
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96816-2396
        • Univ of Hawaii
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • The CORE Ctr
      • Chicago, Illinois, Estados Unidos, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, Estados Unidos, 60608
        • Mt Sinai Hosp Med Ctr / Dept of Pediatrics
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 462025250
        • Indiana Univ Hosp
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Methodist Hosp of Indiana / Life Care Clinic
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Wishard Hosp
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 20201
        • Univ of Marlyand (Pediatric)
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Brigham and Womens Hosp
      • Springfield, Massachusetts, Estados Unidos, 01199
        • Baystate Med Ctr of Springfield
      • Worcester, Massachusetts, Estados Unidos, 016550001
        • Univ of Massachusetts Med School
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48201
        • Children's Hosp of Michigan
      • Detroit, Michigan, Estados Unidos, 48201-1427
        • Hutzel Hospital
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55455-0392
        • Univ of Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 554145
        • Hennepin County Med Ctr
    • Missouri
      • St.Louis, Missouri, Estados Unidos, 63108-2138
        • Washington Univ (St.Louis)
    • New Jersey
      • New Brunswick, New Jersey, Estados Unidos, 08903
        • St Peter's Med Ctr
      • Newark, New Jersey, Estados Unidos, 071032714
        • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
    • New York
      • Bronx, New York, Estados Unidos, 10016
        • Jacobi Med Ctr
      • New York, New York, Estados Unidos, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, Estados Unidos, 10029
        • Metropolitan Hosp Ctr
      • Rochester, New York, Estados Unidos, 14642
        • Univ of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27514
        • Univ of North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 452670405
        • Univ of Cincinnati
      • Cleveland, Ohio, Estados Unidos, 44106
        • Case Western Reserve Univ
      • Cleveland, Ohio, Estados Unidos, 441091998
        • MetroHealth Med Ctr
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Univ of Pittsburgh
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 381052794
        • Saint Jude Children's Research Hosp of Memphis
      • Nashville, Tennessee, Estados Unidos, 37203
        • Vanderbilt Univ Med Ctr
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Univ of Washington
      • Seattle, Washington, Estados Unidos, 981050371
        • Children's Hospital & Medical Center / Seattle ACTU
  • Puerto Rico
      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp

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

13 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Are female and 13 years of age or older.
  • Are between 20 and 34 weeks pregnant at study entry.
  • Had an ultrasound performed at 16 or more weeks of pregnancy.
  • Have consent of a parent or guardian if under 18 years of age. The father of the baby, if available, also must give consent.
  • Have taken the same anti-HIV drugs, including a PI, during the 8 weeks just before study entry. If not taking a PI or any anti-HIV drug, must not have taken a PI during the 8 weeks just before study entry. Patients must carry on this way for the entire study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have diabetes. Patients who have had diabetes caused by pancreas problems or steroid use in the past, but now have normal blood sugar without having to take drugs or special diets, are allowed. Patients who have had blood sugar problems in a past pregnancy also are allowed.
  • Had a serious infection or medical condition within 30 days before study entry.
  • Are enrolled in another study which requires a lot of blood tests.
  • Take, or have taken in the 6 weeks before study entry, any of the following drugs: hormones (growth hormone, testosterone, or steroids), thalidomide, interleukins or interferons, efavirenz, hydroxyurea, drugs to control blood sugar, and anti-cancer drugs.
  • Take, or have taken in the year before study entry, steroids, e.g., prednisone, for more than 14 days in any 3-month period. Inhaled steroids and steroid creams/ointments are allowed.
  • Take, or have taken in the 30 days before study entry, PIs with lovastatin or simvastatin (2 drugs that lower the amount of fat in the blood).
  • Have an ultrasound showing a major abnormality in the baby.
  • Have problems with their pregnancy and/or are expecting more than 1 baby.
  • Abuse drugs or alcohol.

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

Colaboradores e Investigadores

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

Patrocinador

National Institute of Allergy and Infectious Diseases (NIAID)

Colaboradores

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigadores

  • Silla de estudio: Elizabeth Livingston

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.

Publicaciones Generales

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 de registro del estudio

Enviado por primera vez

12 de junio de 2001

Primero enviado que cumplió con los criterios de control de calidad

30 de agosto de 2001

Publicado por primera vez (Estimar)

31 de agosto de 2001

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

7 de agosto de 2006

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

3 de agosto de 2006

Última verificación

1 de agosto de 2006

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ACTG A5084
  • AACTG A5084

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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