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NCT00100542 Clinical Trial

Psychiatric Problems in Children and Adolescents Infected With HIV at Birth

HIV Infections Clinical Trial

Official title:
Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00100542
Other study ID # PACTG P1055
Secondary ID U01AI068632
Status Completed
Phase N/A
First received January 3, 2005
Last updated January 20, 2011
Start date April 2005
Est. completion date September 2006

Study information
Verified date January 2011
Source International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 17 Years
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Puerto Rico San Juan City Hospital San Juan
United States University of Maryland (Pediatric) Baltimore Maryland
United States Childrens Hospital of Boston Boston Massachusetts
United States Bronx Lebanon Hospital Center Bronx New York
United States Jacobi Medical Center Bronx New York
United States Chicago Childrens Memorial Hospital (Pediatric) Chicago Illinois
United States Childrens Hospital (U. Colorado, Denver) Denver Colorado
United States Duke University (Pediatric) Durham North Carolina
United States North Broward Hospital District Fort Lauderdale Florida
United States University of Florida - Health Science Center Jacksonville Florida
United States Long Beach Memorial (Pediatric) Long Beach California
United States Los Angeles County Medical Center/USC Los Angeles California
United States UCLA Medical Center (Pediatric) Los Angeles California
United States St. Jude Childrens Research Hospital, Memphis Memphis Tennessee
United States University of Miami (Pediatric) Miami Florida
United States Yale University School of Medicine New Haven Connecticut
United States Metropolitan Hospital Center New York New York
United States Mt. Sinai Medical Center New York New York
United States New York University School of Medicine New York New York
United States Childrens Hospital of Philadelphia Philadelphia Pennsylvania
United States St. Christophers Hosp. for Children, Philadelphia Philadelphia Pennsylvania
United States 4601 UCSD Mother, Child & Adolescent HIV Program San Diego California
United States UCSF, Moffitt Hospital (Pediatric) San Francisco California
United States Children's Hospital and Regional Medical Center/Seattle Seattle Washington
United States Northwest Family Ctr./Harborview Medical Center Seattle Washington
United States University of Washington Medical Ctr. Seattle Washington
United States University of South Florida St Petersburg Florida
United States State University of New York at Stony Brook Stony Brook New York
United States SUNY Upstate Medical University Syracuse New York
United States Harbor-UCLA Medical Center Torrance California
United States Howard University Hospital Washington District of Columbia
United States University of Massachusetts Medical School Worcester Massachusetts

Sponsors (4)
Lead Sponsor Collaborator
International Maternal Pediatric Adolescent AIDS Clinical Trials Group Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (6)

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. — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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