Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350272
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2006-07-06
Brief Title:
ElvucitabineEfavirenzTenofovir Versus LamivudineEfavirenzTenofovir in Human Immunodeficiency Virus HIV-1 Infected Treatment-naive Participants
Sponsor:
Alexion Pharmaceuticals Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized Blinded 12-week Comparison of ElvucitabineEfavirenzTenofovir Versus LamivudineEfavirenzTenofovir in HIV-1 Infected Treatment-naive Participants There is a 36 Week Open-label Extension Phase for Eligible Participants
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:
None
Brief Summary:
Elvucitabine a novel nucleoside analog is being studied as a treatment for participants with human immunodeficiency virus HIV-1 This Phase 2 study will enroll 60 HIV-1-naive participants to assess the efficacy and safety of elvucitabine compared to lamivudine in combination with tenofovir and efavirenz as measured by changes in the participants HIV-ribonucleic acid RNA level and CD4 cell count The study treatment will be 12 weeks of blinded study medication followed by an additional 84 weeks of open-label treatment if the participants response to treatment meets certain endpoints The pharmacokinetics of elvucitabine will also be assessed during the study
Detailed Description:
Sixty HIV-1-infected clinically stable treatment-naïve adults with no acquired immunodeficiency syndrome AIDS-defining events during the 3 months prior to screening will be randomly assigned to 1 of 2 treatment groups Participant plasma HIV-1 RNA levels must be greater than or equal to 5000 copiesmillimeter mL and CD4 cell counts must be greater than 200 cellsmL and less than 500 cellsmL at Screening Participants must be sensitive to elvucitabine lamivudine and emtricitabine as demonstrated by the absence of the M184V M184I and D237E mutations by TRUGENE HIV-1 Genotyping Kit Participants must be genotypically sensitive to efavirenz negative for K103 or Y188L mutations and tenofovir negative for K65R mutation as demonstrated by TRUGENE HIV-1 Genotyping Kit They must have acceptable hematologic and chemistry parameters
Participants whose HIV-1 RNA levels have decreased at least 2 logs or to below 400 copiesmL by Week 10 may be considered eligible to enter the extension phase of up to 36 weeks of additional treatment Participants in the extension phase will be evaluated at Weeks 14 and 16 and every 4 Weeks until Week 96
Once all participants have completed 12 weeks of treatment and the data are available for all visits through Week 12 the database will be locked and the treatment assignments will be unblinded Any participant who has had less than 48 weeks of treatment will be allowed to continue on the same treatment as initially assigned on an open-label basis through 48 weeks All participants will have 2 post-treatment follow-up visits at 1 and 4 weeks after the end of treatment Concentrations of elvucitabine in the plasma will be measured on Day 1 at Weeks 4 6 8 12 16 24 48 72 96 and at Follow-up
Efficacy will be assessed by measuring plasma HIV-1 RNA levels and CD4 counts at each study visit
Safety evaluation will include vital signs physical examinations electrocardiograms assessments of adverse events AEs measurement of plasma HIV-1 RNA levels and CD4 counts determination of HIV-1 genotype at Screening and at Weeks 12 24 48 and 96 determination of HIV-1 phenotype at Visit 1 and at Weeks 12 24 48 and 96 urine and serum pregnancy tests as well as laboratory analyses that include hematology chemistry and urinalysis
Participants whose HIV-1 RNA levels have decreased at least 2 logs or to below 400 copiesmL by Week 10 may be considered eligible to enter the extension phase of up to 36 weeks of additional treatment Participants in the extension phase will be evaluated at Weeks 14 and 16 and every 4 Weeks until Week 96
Once all participants have completed 12 weeks of treatment and the data are available for all visits through Week 12 the database will be locked and the treatment assignments will be unblinded Any participant who has had less than 48 weeks of treatment will be allowed to continue on the same treatment as initially assigned on an open-label basis through 48 weeks All participants will have 2 post-treatment follow-up visits at 1 and 4 weeks after the end of treatment Concentrations of elvucitabine in the plasma will be measured on Day 1 at Weeks 4 6 8 12 16 24 48 72 96 and at Follow-up
Efficacy will be assessed by measuring plasma HIV-1 RNA levels and CD4 counts at each study visit
Safety evaluation will include vital signs physical examinations electrocardiograms assessments of adverse events AEs measurement of plasma HIV-1 RNA levels and CD4 counts determination of HIV-1 genotype at Screening and at Weeks 12 24 48 and 96 determination of HIV-1 phenotype at Visit 1 and at Weeks 12 24 48 and 96 urine and serum pregnancy tests as well as laboratory analyses that include hematology chemistry and urinalysis
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