Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119405
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2005-07-11
Brief Title:
Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors NRTIs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Role of Mitochondria in the Development of HIV Atrophy
Status:
COMPLETED
Status Verified Date:
2007-12
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:
Nucleoside reverse transcriptase inhibitors NRTIs are a class of anti-HIV Human Immunodeficiency Virus drug that can be an important part of an HIV treatment regimen Because anti-HIV therapy may have negative side effects there is a great need to carefully study HIV infected patients on such regimens One negative side effect observed in many HIV infected patients is lipoatrophy a condition that results in fat loss in the body It is unclear if NRTIs also have a role in the development of mitochondrial toxicity a condition that affects the bodys ability to produce energy The purpose of this study is to observe the effects of an NRTI-based protease inhibitor PI-sparing drug regimen on fat loss in HIV infected treatment-naive adults
Study hypothesis The initiation of NRTI-containing PI-sparing therapy will inhibit mitochondrial DNA mtDNA synthesis and lead to a decrease in mtDNA content in adipose tissue skeletal muscle and peripheral blood mononuclear cells PBMCs will cause deterioration in mitochondrial function will increase fat apoptosis and oxidative damage biomarkers and will lead to progressive decrease in body fat content
Study hypothesis The initiation of NRTI-containing PI-sparing therapy will inhibit mitochondrial DNA mtDNA synthesis and lead to a decrease in mtDNA content in adipose tissue skeletal muscle and peripheral blood mononuclear cells PBMCs will cause deterioration in mitochondrial function will increase fat apoptosis and oxidative damage biomarkers and will lead to progressive decrease in body fat content
Detailed Description:
NRTIs are a mainstay of HIV treatment regimens often part of initial treatment regimens for newly diagnosed patients Recent data suggest that NRTIs are responsible for lipoatrophy a condition marked by progressive fat loss Another negative side effect to antiretroviral ARV regimens is mitochondrial toxicity which can damage the heart nerves muscles kidneys pancreas and liver as well as affecting the bodys ability to produce energy for important life processes It has been hypothesized that lipoatrophy may be related to mitochondrial toxicity but a causal relationship between the two has yet to be established This study will examine HIV infected treatment-naive patients who are initiating their first ARV regimens The regimens will contain 2 NRTI one of which being zidovudine and a non-nucleoside reverse transcriptase inhibitor NNRTI The regimens will not contain any PIs
Patients will participate in this study for 96 weeks There will be 4 study visits at Weeks 12 24 48 and 96 Dual-energy x-ray absorptiometry DEXA scans and fat biopsies will occur at all visits Additionally blood collection for metabolic testing will occur at Week 12 ARVs will not be provided by this study
Patients will participate in this study for 96 weeks There will be 4 study visits at Weeks 12 24 48 and 96 Dual-energy x-ray absorptiometry DEXA scans and fat biopsies will occur at all visits Additionally blood collection for metabolic testing will occur at Week 12 ARVs will not be provided by this study
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 |
|---|---|---|---|
| 1R01-AI060484-01A2A | None | None | None |
| 1R01AI060484-01A2 | NIH | None | httpsreporternihgovquickSearch1R01AI060484-01A2 |