Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476983
Status:
WITHDRAWN
Last Update Posted:
2015-03-30
First Post:
2007-05-20
Brief Title:
Pharmacokinetic and Efficacy of SQVr 1500100 Plus TenofovirEmtricitabine 300200 mg
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Organization:
The HIV Netherlands Australia Thailand Research Collaboration
Study Overview
Official Title:
Pharmacokinetic and Efficacy of Saquinavir Mesylate Film Coated Tablet Ritonavir 1500100 Plus TenofovirEmtricitabine 300200 mg Once Daily in HIV Pretreated Patients
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pharmacokinetic and long term efficacy of TDF SQV film coated tablet 1500100mg once daily plus TDFFTC300200mg once daily
Detailed Description:
This study will be performed in patients who were previously treated with SQV r 1000100mg twice daily or Lopinavirr plus TDFFTC once daily as part of the Gemini study After 48 weeks of the study the patients will be treated with SQV film coated tablet 1500100mg once daily plus TDFFTC300200mg once daily with good CD4 and VL outcomes In this study we would like to evaluate the once-daily dosing of SQV using SQV- SQV film coated tablet 1500ritonavir 100mg in combination with TDFFTC300200mg once daily We believe that the PK parameters of SQV given at 1500mg daily will be equivalent to the 1000mg twice daily dosing when combined with RTV and TDFFTC300200mg OD and that the once daily regimen will have better safety tolerability profile than the twice daily regimen while maintaining good CD4 and VL outcome
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