Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224458
Status:
COMPLETED
Last Update Posted:
2008-04-10
First Post:
2005-09-19
Brief Title:
Combination of Efavirenz and Truvada - COMET Study
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Combination of Efavirenz Truvada COMET Study Phase 4 Evaluation of Switching Twice Daily Combivir to Once-Daily Regimen Co-Formulated Truvada in Virologically Suppressed HIV Infected Patients Taking Efavirenz
Status:
COMPLETED
Status Verified Date:
2008-02
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:
To characterize the risks safety and tolerability effectiveness continued viral load suppression and CD4 changes and benefits safety tolerability adherence general satisfaction with the treatment regimen and QoL of switching from a Combivir BID efavirenz QD regimen to an all QD regimen of Truvadaefavirenz
Detailed Description:
The objectives of this study are to characterize the risks safety and tolerability effectiveness continued viral load suppression and CD4 changes and benefits safety tolerability adherence general satisfaction with the treatment regimen and QoL of switching from a Combivir BID efavirenz QD regimen to an all QD regimen of Truvadaefavirenz
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