Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312039
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2006-04-05
Brief Title:
Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation
Sponsor:
Alexion Pharmaceuticals Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
A 14 Day Randomized Double-blind Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation
Status:
COMPLETED
Status Verified Date:
2023-08
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:
Resistance
Brief Summary:
Human immunodeficiency virus HIV-1 infected participants receiving long-term therapy with lamivudine or emtricitabine nucleoside reverse transcriptase inhibitors NRTIs are at risk for the development of a mutation at position M184 on the HIV reverse transcriptase gene This mutation confers resistance to both drugs 100 fold increase in the concentration of drug producing 50 inhibition IC50
In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation show only a 10-fold increase in IC50 as compared to wild type HIV-1 Alexion Pharmaceuticals Inc intention is to demonstrate that 10 milligrams mg of elvucitabine administered once per day for 14 days with continued background anti-HIV-1 medications will demonstrate a fall in HIV-1 ribonucleic acid RNA plasma levels as compared to baseline The data from this study will guide dosing in future long-term studies in HIV-1 infected participants with the M184V mutation
In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation show only a 10-fold increase in IC50 as compared to wild type HIV-1 Alexion Pharmaceuticals Inc intention is to demonstrate that 10 milligrams mg of elvucitabine administered once per day for 14 days with continued background anti-HIV-1 medications will demonstrate a fall in HIV-1 ribonucleic acid RNA plasma levels as compared to baseline The data from this study will guide dosing in future long-term studies in HIV-1 infected participants with the M184V mutation
Detailed Description:
This was a Phase 2a 14-Day randomized double-blind comparative viral kinetic study of10 mg elvucitabine as compared to lamivudine that was administered once daily QD to HIV-1 infected participants with a documented M184V variant This study also demonstrated the antiviral activity as well as the assessment of safety of the elvucitabine therapy
Participants must be receiving a stable antiretroviral regimen defined as no change in antiretroviral therapy for at least 4 weeks prior to randomization that includes lamivudine or emtricitabine At 72 hours prior to randomization only lamivudine or emtricitabine will be stopped for washout participants will continue to receive the other drugs in their prescribed regimen background antiretroviral therapy during the 72-hour washout period Participants will then be randomized to receive blinded elvucitabine or lamivudine in a 11 ratio and continue to receive their prescribed background antiretroviral therapy for 14 days on an outpatient basis Participants will be followed for an additional 14 days post-treatment for safety unless they enroll in the ACH443-018 extension study where they will continue to be treated and followed for safety
Participants must be receiving a stable antiretroviral regimen defined as no change in antiretroviral therapy for at least 4 weeks prior to randomization that includes lamivudine or emtricitabine At 72 hours prior to randomization only lamivudine or emtricitabine will be stopped for washout participants will continue to receive the other drugs in their prescribed regimen background antiretroviral therapy during the 72-hour washout period Participants will then be randomized to receive blinded elvucitabine or lamivudine in a 11 ratio and continue to receive their prescribed background antiretroviral therapy for 14 days on an outpatient basis Participants will be followed for an additional 14 days post-treatment for safety unless they enroll in the ACH443-018 extension study where they will continue to be treated and followed for safety
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