Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100542
Status:
COMPLETED
Last Update Posted:
2011-01-21
First Post:
2005-01-03
Brief Title:
Psychiatric Problems in Children and Adolescents Infected With HIV at Birth
Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Organization:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Study Overview
Official Title:
Psychiatric Co-Morbidity in Perinatally HIV-Infected Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01AI068632 | NIH | None | httpsreporternihgovquickSearchU01AI068632 |