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Psychiatric Problems in Children and Adolescents Infected With HIV at Birth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00100542
First Posted: January 4, 2005
Last Update Posted: January 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
January 3, 2005
January 4, 2005
January 21, 2011
April 2005
September 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00100542 on ClinicalTrials.gov Archive Site
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Psychiatric Problems in Children and Adolescents Infected With HIV at Birth
Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Children and their caregivers from specific clinics.
  • HIV Infections
  • Mental Disorders
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.
1
All HIV infected and uninfected participants and their caregivers.
Intervention: Behavioral: Psychiatric interviews

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
September 2006
September 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 17 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00100542
PACTG P1055
U01AI068632 ( U.S. NIH Grant/Contract )
Not Provided
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Wende Levy, IMPAACT
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Sharon Nachman, MD Department of Pediatrics, Stony Brook University
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
January 2011