Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122655
Status:
TERMINATED
Last Update Posted:
2005-11-15
First Post:
2005-07-21
Brief Title:
Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
A Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE Study
Status:
TERMINATED
Status Verified Date:
2005-11
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 aim of this trial is to evaluate the impact on fat distribution of switching to NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression
Maintenance of virological suppression and immunological factors are also assessed
Maintenance of virological suppression and immunological factors are also assessed
Detailed Description:
Limitations on achieving complete HIV eradication render it necessary to maintain highly active antiretroviral treatment over long periods which may lead to the development of antiretroviral-associated toxicities The current standard-of-care HAART regimens include a backbone of 2 nucleoside reverse transcriptase inhibitors NRTIs Many studies have demonstrated that NRTIs particularly thymidine analogue nucleosides are important contributors to the development of lipoatrophy This antiretroviral family inhibits also the mitochondrial gamma-DNA polymerase which leads to mitochondrial dysfunction and side effects such as peripheral neuropathy pancreatitis and liver dysfunction
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