Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450580
Status:
COMPLETED
Last Update Posted:
2012-06-07
First Post:
2007-03-21
Brief Title:
HIV-1 Infection Study of Once a Day Versus Twice a Day Protease Inhibitor in Antiretroviral Treatment Naive Adults
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
Study of Once-Daily Versus Twice-Daily Fosamprenavir Plus Ritonavir Administered With AbacavirLamivudine Once-Daily in Antiretroviral-Naive HIV-1 Infected Adult Subjects
Status:
COMPLETED
Status Verified Date:
2012-04
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 is a Phase IIIB 48 Week multicentre randomized open-label parallel group study comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg100mg once-daily to fosamprenavir plus ritonavir 700mg100mg twice-daily both administered with abacavirlamivudine 600mg300mg once-daily in antiretroviral-naive HIV-1 infected adults This study utilizes a group-sequential design with two stages 1 an interim 24 week cohort analysis of approximately 200 subjects and 2 if study continuation criteria are met at this interim analysis further enrolment of an additional 528 subjects followed over a minimum of 48 weeks The objectives of the study are to demonstrate 1 non-inferior antiviral activity of fosamprenavirritonavir 1400mg100mg QD compared to fosamprenavirritonavir 700mg100mg BID and 2 a superior fasting non-HDL lipid profile in subjects receiving fosamprenavirritonavir 1400mg100mg QD
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