Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433992
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2007-02-09
Brief Title:
Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Effects of Thymidine Sparing Regimens on Mitochondrial Metabolism and Adipocyte Apoptosis
Status:
COMPLETED
Status Verified Date:
2017-09
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 observe the effects of certain anti-HIV medications on mitochondrial activity and fat cell death This study will enroll participants from another study ACTG A5202 who are on treatment regimens that do not include zidovudine stavudine or other thymidine-containing anti-HIV medications
Detailed Description:
The main objective of this study is to observe the effects of anti-HIV medication lacking thymidine on mitochondrial metabolism and adipocyte apoptosis fat cell death Changes in mitochondrial metabolism and increases in adipocyte apoptosis are associated with lipoatrophy Lipoatrophy is a common condition characterized by loss of subcutaneous fat and can be caused by many anti-HIV medications This study will examine the metabolic consequences of the use of thymidine analogue-sparing treatment regimens
This study will evaluate HIV infected patients who are enrolled in ACTG A5202 starting their first nucleoside reverse transcriptase inhibitor NRTI-containing regimen This regimen will include either tenofovir disoproxil fumarateemtricitabine TDFFTC or abacavirlamivudine ABC3TC which are thymidine-sparing regimens The changes in mitochondrial activity and fat cell death will be compared between participants taking thymidine-sparing regimens TDFFTC or ABC3TC and thymidine-containing regimens
This study will last for 96 weeks with two study visits occurring at entry and another visit at Week 96 During each visit a dual energy x-ray absorptiometry DEXA scan and blood collection will occur and a fat biopsy will be performed in the lower abdomen under local anesthetic
This study will evaluate HIV infected patients who are enrolled in ACTG A5202 starting their first nucleoside reverse transcriptase inhibitor NRTI-containing regimen This regimen will include either tenofovir disoproxil fumarateemtricitabine TDFFTC or abacavirlamivudine ABC3TC which are thymidine-sparing regimens The changes in mitochondrial activity and fat cell death will be compared between participants taking thymidine-sparing regimens TDFFTC or ABC3TC and thymidine-containing regimens
This study will last for 96 weeks with two study visits occurring at entry and another visit at Week 96 During each visit a dual energy x-ray absorptiometry DEXA scan and blood collection will occur and a fat biopsy will be performed in the lower abdomen under local anesthetic
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