Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257621
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2005-11-21
Brief Title:
GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Pilot Phase II Open-label Single Arm Study to Evaluate the Efficacy Safety Tolerability and Pharmacokinetics of GW640385 When Administered With Ritonavir in Combination With NRTIs for 48 Weeks in HIV-1 Infected Adults
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a proof of concept POC single arm study of GW640385 a protease inhibitor in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors NRTI backbone This study has a 48 week duration and is open to both treatment naive and experienced patients who are HIV positive There are 3 intensive pharmacokinetic PK visits
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