Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440947
Status:
COMPLETED
Last Update Posted:
2012-03-22
First Post:
2007-02-23
Brief Title:
InductionSimplification With Atazanavir Ritonavir AbacavirLamivudine Fixed-Dose Combination In HIV-1 Infection
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
See Detailed Description
Status:
COMPLETED
Status Verified Date:
2011-07
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 study was designed to test the efficacy safety tolerability and durability of the antiviral response between atazanavir ATV ritonavir r abacavirlamivudineABC3TC Fixed dose combination FDC each administered once daily QD for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV r for an additional 48 weeks each in combination with ABC3TC in antiretroviral ART-naive HIV-1 infected HLA-B5701 negative subjects
All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study
All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study
Detailed Description:
Safety and Efficacy of an Initial Regimen of Atazanavir ATV Ritonavir r the AbacavirLamivudine Fixed-Dose Combination Tablet ABC3TC FDC for 36 weeks followed by Simplification to Atazanavir with ABC3TC FDC or Maintenance of the Initial Regimen for an Additional 48 weeks in Antiretroviral-Naive HIV-1 Infected HLA-B5701 Negative Subjects followed by an Optional 60-Week Treatment Extension Phase
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