Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U01AI068632 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | All HIV infected and uninfected participants and their caregivers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychiatric interviews | Behavioral | Measures and questionnaires regarding mental health, pain, and adherence to treatment. No actual treatment or intervention is given as part of this study. |
Inclusion Criteria for HIV Infected Participants:
Inclusion Criteria for HIV Uninfected Participants:
Inclusion Criteria for All Participants:
Exclusion Criteria for HIV Infected Participants:
Exclusion Criteria for All Participants:
Not provided
Not provided
Children and their caregivers from specific clinics.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sharon Nachman, MD | Department of Pediatrics, Stony Brook University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Memorial (Pediatric) | Long Beach | California | 90801 | United States | ||
| Los Angeles County Medical Center/USC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11490035 | Background | 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. | |
| 12177366 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| 90033 |
| United States |
| UCLA Medical Center (Pediatric) | Los Angeles | California | 90095-1752 | United States |
| 4601 UCSD Mother, Child & Adolescent HIV Program | San Diego | California | 92103 | United States |
| UCSF, Moffitt Hospital (Pediatric) | San Francisco | California | 94143-0105 | United States |
| Harbor-UCLA Medical Center | Torrance | California | 90509 | United States |
| Childrens Hospital (U. Colorado, Denver) | Denver | Colorado | 80218-1088 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06504 | United States |
| Howard University Hospital | Washington D.C. | District of Columbia | 20060 | United States |
| North Broward Hospital District | Fort Lauderdale | Florida | 33316 | United States |
| University of Florida - Health Science Center | Jacksonville | Florida | 32209 | United States |
| University of Miami (Pediatric) | Miami | Florida | 33136 | United States |
| University of South Florida | St. Petersburg | Florida | 33701 | United States |
| Chicago Childrens Memorial Hospital (Pediatric) | Chicago | Illinois | 60614 | United States |
| University of Maryland (Pediatric) | Baltimore | Maryland | 21201 | United States |
| Childrens Hospital of Boston | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655-0001 | United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Metropolitan Hospital Center | New York | New York | 10029 | United States |
| Mt. Sinai Medical Center | New York | New York | 10029 | United States |
| State University of New York at Stony Brook | Stony Brook | New York | 11794-8111 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Bronx Lebanon Hospital Center | The Bronx | New York | 10457 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Duke University (Pediatric) | Durham | North Carolina | 27710 | United States |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-4318 | United States |
| St. Christophers Hosp. for Children, Philadelphia | Philadelphia | Pennsylvania | 19134 | United States |
| St. Jude Childrens Research Hospital, Memphis | Memphis | Tennessee | 38105-2794 | United States |
| Children's Hospital and Regional Medical Center/Seattle | Seattle | Washington | 98105 | United States |
| Northwest Family Ctr./Harborview Medical Center | Seattle | Washington | 98105 | United States |
| University of Washington Medical Ctr. | Seattle | Washington | 98105 | United States |
| San Juan City Hospital | San Juan | Puerto Rico |
| 15173535 | Background | 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. |
| 11383959 | Background | Lwin R, Melvin D. Paediatric HIV infection. J Child Psychol Psychiatry. 2001 May;42(4):427-38. |
| 12563068 | Background | 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. |
| 19596734 | Result | 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. |
| 22312169 | Derived | 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided