Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006064
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2000-06-16
Brief Title:
The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children
Status:
COMPLETED
Status Verified Date:
2014-10
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 see how beginning or changing anti-HIV medications affects the body composition weight height growth body fat and muscle mass or fat and muscle distribution of HIV-infected children This study also looks at how changes in body composition relate to changes in viral load level of HIV in the blood CD4 cell counts height and weight in HIV-infected children This study also compares changes in body composition to levels of cytokines proteins in the body that affect some immune cells in HIV-infected children who are beginning or changing anti-HIV therapy
Though studies have been done on adults little is known about the effects of HIV infection and anti-HIV drugs on body composition in children One theory is that changes in body composition can predict the failure of anti-HIV treatment If this is true body composition measurements can be as useful as CD4 cell counts in determining drug effectiveness
Though studies have been done on adults little is known about the effects of HIV infection and anti-HIV drugs on body composition in children One theory is that changes in body composition can predict the failure of anti-HIV treatment If this is true body composition measurements can be as useful as CD4 cell counts in determining drug effectiveness
Detailed Description:
Despite accumulating data in adults little information is available regarding the effects of HIV infection and antiretroviral therapy on body composition in children Preliminary information indicates that lean body mass is lost in preference to fat mass in HIV-infected children supporting the theory that failure to thrive in HIV infection is often cytokine mediated It can be hypothesized that changes in body composition lean body mass may predict changes in weight growth velocity and may give an early clinical indication of treatment failure If so body composition measurement may yield an additional outcome measure for clinical trials equivalent in utility to other laboratory measures of treatment response eg persistent CD4 cell count changes Additionally if body composition changes are highly correlated with responses in viral load body composition may prove to be a more affordable measure of antiretroviral effectiveness in developing countries
This study is a nonrandomized observational study Children are recruited to each of 4 age strata
Stratum A 1 month to 18 months Stratum B greater than 18 months to 3 years Stratum C greater than 3 years to 8 years Stratum D greater than 8 years to less than 13 years Children beginning or changing antiretroviral therapy and fulfilling the study specifications may be enrolled in the study Children have 5 outpatient clinic visits at entry and at 12 24 36 and 48 weeks for anthropometry body composition by bioelectrical impedance analysis cytokine levels viral load CD4 cell count and markers of lipid and glucose metabolism
This study is a nonrandomized observational study Children are recruited to each of 4 age strata
Stratum A 1 month to 18 months Stratum B greater than 18 months to 3 years Stratum C greater than 3 years to 8 years Stratum D greater than 8 years to less than 13 years Children beginning or changing antiretroviral therapy and fulfilling the study specifications may be enrolled in the study Children have 5 outpatient clinic visits at entry and at 12 24 36 and 48 weeks for anthropometry body composition by bioelectrical impedance analysis cytokine levels viral load CD4 cell count and markers of lipid and glucose metabolism
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 |
|---|---|---|---|
| ACTG P1010 | Registry Identifier | DAIDS ES | None |
| 10814 | REGISTRY | None | None |
| PACTG P1010 | None | None | None |