Organic Mental Disorders |
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Clinical Trial: Psychiatric Problems in Children and Adolescents Infected with HIV at Birth
This study is not yet open for patient recruitment.
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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 |
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| HIV Infections Mental Disorders |
MedlinePlus related topics: AIDS; Mental Health
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents
Expected Total Enrollment: 800
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 - 17 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria for HIV Infected Participants:
- Acquired HIV through mother-to-child transmission
- At least one CD4 count, CD4%, total lymphocyte count, and viral load documented within 90 days of study entry
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:
Exclusion Criteria for All Participants:
- IQ of 69 or lower
Location Information
District of Columbia
Howard University Hospital, Washington, District of Columbia, 20060, United States
Sharon Nachman, MD, Study Chair, Department of Pediatrics, Stony Brook University
More Information
Click here for more information on HIV and pregnancy
Haga clic aquí para ver información sobre este ensayo clínico en español.
Publications
Bachanas PJ, Kullgren KA, Schwartz KS, Lanier B, McDaniel JS, Smith J, Nesheim S. Predictors of psychological adjustment in school-age children infected with HIV. J Pediatr Psychol. 2001 Sep;26(6):343-52.
De Luca A, Ciancio BC, Larussa D, Murri R, Cingolani A, Rizzo MG, Giancola ML, Ammassari A, Ortona L. Correlates of independent HIV-1 replication in the CNS and of its control by antiretrovirals. Neurology. 2002 Aug 13;59(3):342-7.
Gaughan DM, Hughes MD, Oleske JM, Malee K, Gore CA, Nachman S; Pediatric AIDS Clinical Trials Group 219C Team. Psychiatric hospitalizations among children and youths with human immunodeficiency virus infection. Pediatrics. 2004 Jun;113(6):e544-51.
Mellins CA, Smith R, O'Driscoll P, Magder LS, Brouwers P, Chase C, Blasini I, Hittleman J, Llorente A, Matzen E; NIH NIAID/NICHD/NIDA-Sponsored Women and Infant Transmission Study Group. High rates of behavioral problems in perinatally HIV-infected children are not linked to HIV disease. Pediatrics. 2003 Feb;111(2):384-93.
Record last reviewed: April 2005
Last Updated: April 7, 2005
Record first received: January 3, 2005
ClinicalTrials.gov Identifier: NCT00100542
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Healing with Homeopathy (HealthWorld)

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