Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069004
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2003-09-12
Brief Title:
A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Prevalence of Morphologic and Metabolic Abnormalities in Vertically HIV-Infected and Uninfected Children and Youth
Status:
COMPLETED
Status Verified Date:
2014-01
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 assess the prevalence of metabolic and physical abnormalities in HIV infected via mother-to-child transmission and uninfected children and youth Metabolism body composition bone density and other factors will be assessed in relationship to participants exposure to highly active antiretroviral therapy HAART
Detailed Description:
Despite advances in HIV care associated with HAART many patients on HAART regimens develop physical and metabolic problems including changes in body fat distribution lipodystrophy osteopenia and osteoporosis dyslipidemia and hyperlactatemia Early studies suggest that protease inhibitors PIs were directly responsible for HIV Lipodystrophy Syndrome HLS and skeletal complications in HAART-treated patients This study will compare HIV infected HAART-treated children and youth and their uninfected counterparts to make connections between HAART HLS and skeletal and metabolic problems The study is the first to address the prevalence and risk assessment of these complications in children and will be useful in predicting long-term prognosis in HIV patients who use or have used HAART
There will be three groups in the study Group 1 participants will be uninfected volunteers who will receive no protocol-specific treatment or other intervention Vertically infected HIV patients in Groups 2 and 3 will continue their current HAART either on a non-PI-containing regimen Group 2 or a PI-containing regimen Group 3 Screening evaluations will be conducted within 30 days prior to study entry Study evaluations may be completed at study entry or over the course of up to 3 study visits All participants will undergo whole body and regional DEXA scans to assess bone density measurements to determine sexual maturity and blood work
There will be three groups in the study Group 1 participants will be uninfected volunteers who will receive no protocol-specific treatment or other intervention Vertically infected HIV patients in Groups 2 and 3 will continue their current HAART either on a non-PI-containing regimen Group 2 or a PI-containing regimen Group 3 Screening evaluations will be conducted within 30 days prior to study entry Study evaluations may be completed at study entry or over the course of up to 3 study visits All participants will undergo whole body and regional DEXA scans to assess bone density measurements to determine sexual maturity and blood work
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 |
|---|---|---|---|
| PACTG P1045 | Registry Identifier | DAIDS ES | None |
| 10108 | REGISTRY | None | None |