Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126880
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2005-08-03
Brief Title:
AVX754 a New Nucleoside Reverse Transcriptase Inhibitor NRTI to Treat Drug-resistant HIV
Sponsor:
Avexa
Organization:
Avexa
Study Overview
Official Title:
A Phase II Randomised Double-blind Dose-ranging Study of AVX754 Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V Mutation in Reverse Transcriptase
Status:
COMPLETED
Status Verified Date:
2011-06
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 study will measure how safe and effective AVX754 a new drug for the treatment of HIV is in treating HIV-1 infected people who have failed treatment with lamivudine
Detailed Description:
Lamivudine or emtricitabine are commonly used in combination with other drugs for first-line treatment of HIV infection Although effective initially many people later on develop resistance to some or all of the drugs including lamivudine leading to virological failure Resistance is associated with characteristic mutations which for lamivudine is the M184V mutation A change to new active drugs must take place when patients fail their current regime to regain control of the virus Although there are other types of drugs available for second line treatment there is currently no fully active well tolerated cytidine analogue that can replace lamivudine in a second-line regimen when patients fail first line treatment This study will measure the efficacy and safety of AVX754 a novel cytidine analogue with activity against HIV resistant to other nucleosides as part of a new regimen to treat patients who have failed treatment containing lamivudine compared to the best alternative new regimen which continues to include lamivudine
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