Ignite Creation Date:
2024-05-05 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00643968
Status:
COMPLETED
Last Update Posted:
2008-06-30
First Post:
2008-03-20
Brief Title:
Tenofovir DF Efavirenz TDFEFV Versus Tenofovir DF Efavirenz Lamivudine TDFEFV3TC Maintenance Regimen in Virologically Controlled Patients COOL Trial
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Randomized Multicenter Open-Label Pilot Trial to Evaluate the Efficacy and Safety of Switching HIV-1 Stable Infected Patients Under HAART to a New Once Daily Triple Therapy Combination Including EFV3TCTDF Versus a Dual QD Therapy Containing EFVTDF
Status:
COMPLETED
Status Verified Date:
2008-06
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:
COOL
Brief Summary:
Primary objective Evaluation of the efficacy of TDF3TCEFV versus TDFEFV QD to maintain plasma HIV-1 RNA BLQ 50 copiesmL cmL at 48 weeks W48
Main Secondary objectives
Comparison of the two arms for genotypic resistance profile in case of virological failure
CD4 changes from baseline
Evolution of the lipid profile and morphological changes in fat distribution and safety
Efficacy and genotypic profile data results of lipid markers morphological changes and main biological parameters
Main Secondary objectives
Comparison of the two arms for genotypic resistance profile in case of virological failure
CD4 changes from baseline
Evolution of the lipid profile and morphological changes in fat distribution and safety
Efficacy and genotypic profile data results of lipid markers morphological changes and main biological parameters
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