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

Sponsor:

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

Study Description

Brief Summary:

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 or disease	Intervention/treatment
HIV Infections Mental Disorders	Behavioral: Psychiatric interviews

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.

Study Design


Study Type :	Observational
Estimated Enrollment :	800 participants
Observational Model:	Case Control
Time Perspective:	Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.

Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 17 Years (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

Show 32 Study Locations

Sponsors and Collaborators

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)

Investigators


Study Chair:	Sharon Nachman, MD	Department of Pediatrics, Stony Brook University

More Information

Publications of Results:

Chernoff M, Nachman S, Williams P, Brouwers P, Heston J, Hodge J, Di Poalo V, Deygoo NS, Gadow KD; IMPAACT P1055 Study Team. Mental health treatment patterns in perinatally HIV-infected youth and controls. Pediatrics. 2009 Aug;124(2):627-36. doi: 10.1542/peds.2008-2441. Epub 2009 Jul 13.

Other 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.

Lwin R, Melvin D. Paediatric HIV infection. J Child Psychol Psychiatry. 2001 May;42(4):427-38. Review.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nachman S, Chernoff M, Williams P, Hodge J, Heston J, Gadow KD. Human immunodeficiency virus disease severity, psychiatric symptoms, and functional outcomes in perinatally infected youth. Arch Pediatr Adolesc Med. 2012 Jun 1;166(6):528-35. doi: 10.1001/archpediatrics.2011.1785.


Responsible Party:	Wende Levy, IMPAACT
ClinicalTrials.gov Identifier:	NCT00100542 History of Changes
Other Study ID Numbers:	PACTG P1055 U01AI068632 ( U.S. NIH Grant/Contract )
First Posted:	January 4, 2005 Key Record Dates
Last Update Posted:	January 21, 2011
Last Verified:	January 2011

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 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 Schizophrenia Spectrum and Other Psychotic Disorders

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