Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270556
Status:
COMPLETED
Last Update Posted:
2008-04-10
First Post:
2005-12-23
Brief Title:
Phase II Comparator Study of Substitution of Tenofovir or Abacavir Receiving Thymidine Analogue as Part of HAART
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Phase II Open-LabelRandomised Comparator Study of Substitution wTenofovir or Abacavir in HIV-1 Infected Individuals wViral Load Less 50 CopiesmL Receiving a Thymidine Analogue Zidovudine or Stavudine as Part of HAART
Status:
COMPLETED
Status Verified Date:
2008-04
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:
This 48 week study is designed to compare the substitution of the thymidine analogues zidovudine ZDV or stavudine D4T with either tenofovir DF or abacavir in patients treated with highly active antiretroviral therapy HAART and show improved outcomes on total limb fat mass improved body shape by dual energy x-ray absorptiometry DEXA and computed tomography CT scans and improved cholesterol and tryglicerides
Detailed Description:
A previous study substituting zidovudine or stavudine to abacavir in patients with severe or moderate lipoatrophy has shown an increase in limb fat DEXA This study was conducted over a 24 week period and although improved outcomes were documented by objective measures DEXA scans subjective observation did not correspond Longer-term follow up of these patients is required
This 48 week study is designed to compare the substitution of the thymidine analogues zidovudine ZDV or stavudine D4T with either tenofovir DF or abacavir in patients treated with highly active antiretroviral therapy HAART and show improved outcomes on total limb fat mass improved body shape by dual energy x-ray absorptiometry DEXA and computed tomography CT scans and improved cholesterol and tryglicerides
This 48 week study is designed to compare the substitution of the thymidine analogues zidovudine ZDV or stavudine D4T with either tenofovir DF or abacavir in patients treated with highly active antiretroviral therapy HAART and show improved outcomes on total limb fat mass improved body shape by dual energy x-ray absorptiometry DEXA and computed tomography CT scans and improved cholesterol and tryglicerides
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