Psychiatric Problems in Children and Adolescents Infected With HIV at Birth

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00100542
First received: January 3, 2005
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
HIV Infections
Mental Disorders
Behavioral: Psychiatric interviews

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents

Resource links provided by NLM:


Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Estimated Enrollment: 800
Study Start Date: April 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
All HIV infected and uninfected participants and their caregivers.
Behavioral: Psychiatric interviews
Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children and their caregivers from specific clinics.

Criteria

Inclusion Criteria for HIV Infected Participants:

  • Acquired HIV through mother-to-child transmission

Inclusion Criteria for HIV Uninfected Participants:

  • HIV uninfected

Inclusion Criteria 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

Exclusion Criteria for HIV Infected Participants:

  • Acquired HIV through adult high-risk behavior, blood transfusion, or abuse

Exclusion Criteria for All Participants:

  • IQ of 69 or lower, for participants whose primary language is English. More information on this criterion can be found in the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100542

  Hide Study Locations
Locations
United States, California
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
UCLA Medical Center (Pediatric)
Los Angeles, California, United States, 90095-1752
Los Angeles County Medical Center/USC
Los Angeles, California, United States, 90033
4601 UCSD Mother, Child & Adolescent HIV Program
San Diego, California, United States, 92103
UCSF, Moffitt Hospital (Pediatric)
San Francisco, California, United States, 94143-0105
Harbor-UCLA Medical Center
Torrance, California, United States, 90509
United States, Colorado
Childrens Hospital (U. Colorado, Denver)
Denver, Colorado, United States, 80218-1088
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06504
United States, District of Columbia
Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Florida
North Broward Hospital District
Fort Lauderdale, Florida, United States, 33316
University of Florida - Health Science Center
Jacksonville, Florida, United States, 32209
University of Miami (Pediatric)
Miami, Florida, United States, 33136
University of South Florida
St Petersburg, Florida, United States, 33701
United States, Illinois
Chicago Childrens Memorial Hospital (Pediatric)
Chicago, Illinois, United States, 60614
United States, Maryland
University of Maryland (Pediatric)
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Childrens Hospital of Boston
Boston, Massachusetts, United States, 02115
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655-0001
United States, New York
Bronx Lebanon Hospital Center
Bronx, New York, United States, 10457
Jacobi Medical Center
Bronx, New York, United States, 10461
New York University School of Medicine
New York, New York, United States, 10016
Mt. Sinai Medical Center
New York, New York, United States, 10029
Metropolitan Hospital Center
New York, New York, United States, 10029
State University of New York at Stony Brook
Stony Brook, New York, United States, 11794-8111
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University (Pediatric)
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4318
St. Christophers Hosp. for Children, Philadelphia
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
St. Jude Childrens Research Hospital, Memphis
Memphis, Tennessee, United States, 38105-2794
United States, Washington
Children's Hospital and Regional Medical Center/Seattle
Seattle, Washington, United States, 98105
Northwest Family Ctr./Harborview Medical Center
Seattle, Washington, United States, 98105
University of Washington Medical Ctr.
Seattle, Washington, United States, 98105
Puerto Rico
San Juan City Hospital
San Juan, Puerto Rico
Sponsors and Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Investigators
Study Chair: Sharon Nachman, MD Department of Pediatrics, Stony Brook University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wende Levy, IMPAACT
ClinicalTrials.gov Identifier: NCT00100542     History of Changes
Other Study ID Numbers: PACTG P1055, U01AI068632
Study First Received: January 3, 2005
Last Updated: January 20, 2011
Health Authority: United States: Federal Government

Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
Treatment Experienced
Treatment Naive
Psychopathology
Anti-Retroviral Agents
Child
Adolescent

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Mental Disorders
Psychotic Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Schizophrenia and Disorders with Psychotic Features
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014