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Ensayos clínicos

Ensayos clínicos

Psychiatric Problems in Children and Adolescents Infected With HIV at Birth

Patrocinador(es) del estudio: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Números de identificación: NCT00100542, PACTG P1055
  • Concluido

Propósito del estudio

The purpose of this study is to determine whether HIV and anti-HIV drugs cause mental health problems or make mental health problems worse in children and adolescents who were infected with HIV at birth.

Afección:
Infecciones por el VIH
Trastornos mentales

Detalles del estudio

Research has shown that HIV is able to penetrate the blood-brain barrier and may significantly affect the central nervous system (CNS). Although the effects of HIV on the CNS are not fully understood, there is growing evidence that the effects are psychosocial in nature; HIV infected children experience higher rates of psychiatric symptoms and hospitalizations than their uninfected counterparts. Confounding the HIV CNS relationship is evidence suggesting that the CNS effects of HIV may also be related to antiretroviral treatment. This study will examine the rates and severity of psychiatric symptoms in both HIV infected and uninfected children and adolescents. In addition, this study will determine the relationship between duration of antiretroviral treatment and psychiatric symptoms.



No treatment will be given as part of this study. The study will last for 96 weeks and be divided into two parts. In Part 1, HIV infected and uninfected participants and their caregivers will complete a series of measures and questionnaires regarding mental health, pain, and adherence to treatment. In Part 2, all participants and their caregivers will complete a subset of the original measures at Weeks 48 and 96. This follow-up part of the study will assess any long-term changes in psychiatric symptoms. In addition, a subset of HIV infected and uninfected participants and their caregivers will take part in psychiatric interviews at specified study sites. A portion of these interviews will be audio-taped.Research has shown that HIV is able to penetrate the blood-brain barrier and may significantly affect the central nervous system (CNS). Although the effects of HIV on the CNS are not fully understood, there is growing evidence that the effects are psychosocial in nature; HIV infected children experience higher rates of psychiatric symptoms and hospitalizations than their uninfected counterparts. Confounding the HIV CNS relationship is evidence suggesting that the CNS effects of HIV may also be related to antiretroviral treatment. This study will examine the rates and severity of psychiatric symptoms in both HIV infected and uninfected children and adolescents. In addition, this study will determine the relationship between duration of antiretroviral treatment and psychiatric symptoms.



No treatment will be given as part of this study. The study will last for 96 weeks and be divided into two parts. In Part 1, HIV infected and uninfected participants and their caregivers will complete a series of measures and questionnaires regarding mental health, pain, and adherence to treatment. In Part 2, all participants and their caregivers will complete a subset of the original measures at Weeks 48 and 96. This follow-up part of the study will assess any long-term changes in psychiatric symptoms. In addition, a subset of HIV infected and uninfected participants and their caregivers will take part in psychiatric interviews at specified study sites. A portion of these interviews will be audio-taped.

Criterios de inclusión

    for HIV Infected Participants:
    • Acquired HIV through mother-to-child transmission
    for HIV Uninfected Participants:
    • HIV uninfected
    for All Participants:
    • Living with same parent or primary caregiver for at least 12 months prior to study screening
    • Willing and able to provide consent or assent

Criterios de exclusión

    for HIV Infected Participants:
    • Acquired HIV through adult high-risk behavior, blood transfusion, or abuse

Centros de estudio/contactos

California

    Long Beach Memorial (Pediatric), Long Beach, California, 90801, United States

    UCLA Medical Center (Pediatric), Los Angeles, California, 90095-1752, United States

    Los Angeles County Medical Center/USC, Los Angeles, California, 90033, United States

    4601 UCSD Mother, Child & Adolescent HIV Program, San Diego, California, 92103, United States

    UCSF, Moffitt Hospital (Pediatric), San Francisco, California, 94143-0105, United States

    Harbor-UCLA Medical Center, Torrance, California, 90509, United States

Colorado

    Childrens Hospital (U. Colorado, Denver), Denver, Colorado, 80218-1088, United States

Connecticut

    Yale University School of Medicine, New Haven, Connecticut, 06504, United States

District of Columbia

    Howard University Hospital, Washington, District of Columbia, 20060, United States

Florida

    North Broward Hospital District, Fort Lauderdale, Florida, 33316, United States

    University of Florida - Health Science Center, Jacksonville, Florida, 32209, United States

    University of Miami (Pediatric), Miami, Florida, 33136, United States

    University of South Florida, St Petersburg, Florida, 33701, United States

Illinois

    Chicago Childrens Memorial Hospital (Pediatric), Chicago, Illinois, 60614, United States

Maryland

    University of Maryland (Pediatric), Baltimore, Maryland, 21201, United States

Massachusetts

    Childrens Hospital of Boston, Boston, Massachusetts, 02115, United States

    University of Massachusetts Medical School, Worcester, Massachusetts, 01655-0001, United States

New York

    Bronx Lebanon Hospital Center, Bronx, New York, 10457, United States

    Jacobi Medical Center, Bronx, New York, 10461, United States

    New York University School of Medicine, New York, New York, 10016, United States

    Mt. Sinai Medical Center, New York, New York, 10029, United States

    Metropolitan Hospital Center, New York, New York, 10029, United States

    State University of New York at Stony Brook, Stony Brook, New York, 11794-8111, United States

    SUNY Upstate Medical University, Syracuse, New York, 13210, United States

North Carolina

    Duke University (Pediatric), Durham, North Carolina, 27710, United States

Pennsylvania

    Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104-4318, United States

    St. Christophers Hosp. for Children, Philadelphia, Philadelphia, Pennsylvania, 19134, United States

Tennessee

    St. Jude Childrens Research Hospital, Memphis, Memphis, Tennessee, 38105-2794, United States

Washington

    Children's Hospital and Regional Medical Center/Seattle, Seattle, Washington, 98105, United States

    Northwest Family Ctr./Harborview Medical Center, Seattle, Washington, 98105, United States

    University of Washington Medical Ctr., Seattle, Washington, 98105, United States

    San Juan City Hospital, San Juan, Washington, 98105, Puerto Rico

Actualizado: 9 de enero del 2006

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