NCT00100542

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2005

Geographic Reach
2 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

January 21, 2011

Status Verified

January 1, 2011

Enrollment Period

1.4 years

First QC Date

January 3, 2005

Last Update Submit

January 20, 2011

Conditions

Keywords

Treatment ExperiencedTreatment NaivePsychopathologyAnti-Retroviral AgentsChildAdolescent

Study Arms (1)

1

All HIV infected and uninfected participants and their caregivers.

Behavioral: Psychiatric interviews

Interventions

Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study.

1

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children and their caregivers from specific clinics.

You may qualify if:

  • Acquired HIV through mother-to-child transmission
  • HIV uninfected
  • Living with same parent or primary caregiver for at least 12 months prior to study screening
  • Willing and able to provide consent or assent

You may not qualify if:

  • Acquired HIV through adult high-risk behavior, blood transfusion, or abuse
  • IQ of 69 or lower, for participants whose primary language is English. More information on this criterion can be found in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Long Beach Memorial (Pediatric)

Long Beach, California, 90801, United States

Location

Los Angeles County Medical Center/USC

Los Angeles, California, 90033, United States

Location

UCLA Medical Center (Pediatric)

Los Angeles, California, 90095-1752, United States

Location

4601 UCSD Mother, Child & Adolescent HIV Program

San Diego, California, 92103, United States

Location

UCSF, Moffitt Hospital (Pediatric)

San Francisco, California, 94143-0105, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Childrens Hospital (U. Colorado, Denver)

Denver, Colorado, 80218-1088, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06504, United States

Location

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

North Broward Hospital District

Fort Lauderdale, Florida, 33316, United States

Location

University of Florida - Health Science Center

Jacksonville, Florida, 32209, United States

Location

University of Miami (Pediatric)

Miami, Florida, 33136, United States

Location

University of South Florida

St. Petersburg, Florida, 33701, United States

Location

Chicago Childrens Memorial Hospital (Pediatric)

Chicago, Illinois, 60614, United States

Location

University of Maryland (Pediatric)

Baltimore, Maryland, 21201, United States

Location

Childrens Hospital of Boston

Boston, Massachusetts, 02115, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655-0001, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Metropolitan Hospital Center

New York, New York, 10029, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

State University of New York at Stony Brook

Stony Brook, New York, 11794-8111, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Bronx Lebanon Hospital Center

The Bronx, New York, 10457, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Duke University (Pediatric)

Durham, North Carolina, 27710, United States

Location

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318, United States

Location

St. Christophers Hosp. for Children, Philadelphia

Philadelphia, Pennsylvania, 19134, United States

Location

St. Jude Childrens Research Hospital, Memphis

Memphis, Tennessee, 38105-2794, United States

Location

Children's Hospital and Regional Medical Center/Seattle

Seattle, Washington, 98105, United States

Location

Northwest Family Ctr./Harborview Medical Center

Seattle, Washington, 98105, United States

Location

University of Washington Medical Ctr.

Seattle, Washington, 98105, United States

Location

San Juan City Hospital

San Juan, Puerto Rico

Location

Related Publications (7)

  • 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.

    PMID: 11490035BACKGROUND
  • 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.

    PMID: 12177366BACKGROUND
  • 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.

    PMID: 15173535BACKGROUND
  • Lwin R, Melvin D. Paediatric HIV infection. J Child Psychol Psychiatry. 2001 May;42(4):427-38.

    PMID: 11383959BACKGROUND
  • 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.

    PMID: 12563068BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

HIV InfectionsMental Disorders

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Sharon Nachman, MD

    Department of Pediatrics, Stony Brook University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

January 3, 2005

First Posted

January 4, 2005

Study Start

April 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

January 21, 2011

Record last verified: 2011-01

Locations