Clinical trial NCT00100542: Psychiatric Problems in Children and Adolescents Infected With HIV at Birth
Official title: Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Mental Disorders
Keywords: Treatment Experienced
Treatment Naive
Psychopathology
Anti-Retroviral Agents
Child
Adolescent
Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Institute of Mental Health (NIMH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2005-01-04
Enrollment: 800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and their caregivers from specific clinics.

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.

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial (Pediatric)
state: California
city: Los Angeles
country: United States
facility: Los Angeles County Medical Center/USC
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center (Pediatric)
state: California
city: San Diego
country: United States
facility: 4601 UCSD Mother, Child & Adolescent HIV Program
state: California
city: San Francisco
country: United States
facility: UCSF, Moffitt Hospital (Pediatric)
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Denver
country: United States
facility: Childrens Hospital (U. Colorado, Denver)
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: North Broward Hospital District
state: Florida
city: Jacksonville
country: United States
facility: University of Florida - Health Science Center
state: Florida
city: Miami
country: United States
facility: University of Miami (Pediatric)
state: Florida
city: St Petersburg
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Chicago Childrens Memorial Hospital (Pediatric)
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland (Pediatric)
state: Maryland
city: Boston
country: United States
facility: Childrens Hospital of Boston
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Bronx
country: United States
facility: Bronx Lebanon Hospital Center
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: New York
country: United States
facility: Metropolitan Hospital Center
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: Stony Brook
country: United States
facility: State University of New York at Stony Brook
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Durham
country: United States
facility: Duke University (Pediatric)
state: North Carolina
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christophers Hosp. for Children, Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Childrens Research Hospital, Memphis
state: Tennessee
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center/Seattle
state: Washington
city: Seattle
country: United States
facility: Northwest Family Ctr./Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Ctr.
state: Washington
city: San Juan
country: Puerto Rico
facility: San Juan City Hospital
Study officials:
affiliation: Department of Pediatrics, Stony Brook University
name: Sharon Nachman, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1093/jpepsy/26.6.343.
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. doi: 10.1212/wnl.59.3.342.
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. doi: 10.1542/peds.113.6.e544.
citation: Lwin R, Melvin D. Paediatric HIV infection. J Child Psychol Psychiatry. 2001 May;42(4):427-38.
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. doi: 10.1542/peds.111.2.384.
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/peds.2008-2441. Epub 2009 Jul 13.
citation: 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.