Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002416
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Comparing FTC and Lamivudine in HIV-Infected Patients on a Stable Anti-HIV Drug Combination
Sponsor:
Triangle Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Open-Label Equivalence Study of FTC Versus Lamivudine in Patients on a Stable Triple Antiretroviral Therapy Regimen Containing Lamivudine Stavudine or Zidovudine and a Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor
Status:
COMPLETED
Status Verified Date:
2000-03
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:
The purpose of this study is to compare two anti-HIV drugs FTC and lamivudine 3TC when given with either stavudine d4T or zidovudine ZDV and one other anti-HIV drug
Detailed Description:
Patients are randomized to one of two arms in a 21 ratio weighted to Arm 1 Arm 1 Replace lamivudine with FTC while continuing on current background regimen Arm 2 Continue on current lamivudine-containing regimen Patients are further stratified based upon screening plasma HIV-1 RNA and background therapy Stratum 1 Less than 50 copiesml PI protease inhibitor in treatment regimen Stratum 2 Less than 50 copiesml NNRTI nonnucleoside reverse transcriptase inhibitor in treatment regimen Stratum 3 50-400 copiesml PI in treatment regimen Stratum 4 50-400 copiesml NNRTI in treatment regimen Clinic visits occur at regular intervals throughout the 48-week study period to determine viral load
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: