Psychiatric Problems in Children and Adolescents Infected With HIV at Birth
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|ClinicalTrials.gov Identifier: NCT00100542|
Recruitment Status : Completed
First Posted : January 4, 2005
Last Update Posted : January 21, 2011
|Condition or disease||Intervention/treatment|
|HIV Infections Mental Disorders||Behavioral: Psychiatric interviews|
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.
|Study Type :||Observational|
|Estimated Enrollment :||800 participants|
|Observational Model:||Case Control|
|Official Title:||Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||September 2006|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100542
|Study Chair:||Sharon Nachman, MD||Department of Pediatrics, Stony Brook University|