Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139178
Status:
COMPLETED
Last Update Posted:
2005-09-05
First Post:
2005-08-30
Brief Title:
Switching From Zidovudine to an NNRTI or LopinavirRitonavir in Patients Treated With Zidovudine LamivudineAbacavir
Sponsor:
Danish HIV Research Group
Organization:
Danish HIV Research Group
Study Overview
Official Title:
Switching From Zidovudine to an NNRTI or LopinavirRitonavir in Patients Treated With Zidovudine LamivudineAbacavir Influence on Metabolic Abnormalities
Status:
COMPLETED
Status Verified Date:
2005-08
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:
Highly active antiretroviral therapy HAART has improved the long time survival of HIV infected individuals However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy
The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy
We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir zidovudinelamivudineabacavir
The patients will be offered an NRTI or lopinavirritonavir instead of zidovudine or they can choose to continue with Trizivir
The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning
The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy
We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir zidovudinelamivudineabacavir
The patients will be offered an NRTI or lopinavirritonavir instead of zidovudine or they can choose to continue with Trizivir
The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning
Detailed Description:
None
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