Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135460
Status:
UNKNOWN
Last Update Posted:
2006-03-14
First Post:
2005-08-25
Brief Title:
Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
Sponsor:
Danish HIV Research Group
Organization:
Danish HIV Research Group
Study Overview
Official Title:
Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV Influence on Morphological and Metabolic Disorders A Randomized Open-Label Multicenter Trial
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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
There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor NRTI-sparing regimens The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy and patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy
The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen
The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry DEXA-scanning
There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor NRTI-sparing regimens The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy and patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy
The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen
The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry 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