Status:
COMPLETED
Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Achillion, a wholly owned subsidiary of Alexion
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 deve...
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 participant...
Eligibility Criteria
Inclusion
- Clinically stable HIV-1 infected participants
- Ages \>18 and \<65 years
- Documented M184V mutation
- CD4 cell count \>100 cells/mL
- Plasma HIV-1 RNA levels \>5000 and \<150,000 copies/milliliter (mL)
- Currently receiving lamivudine or emtricitabine
- Other hematologic and metabolic parameters must be met.
- Provide written informed consent
- Other inclusion criteria apply.
Exclusion
- Hepatitis B antigen positive
- HIV-1 genotype positive for more than or equal to 4 protease mutations
- HIV-1 genotype positive for more than or equal to 2 non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations
- Previous therapy with cytotoxic or myelosuppressive drugs in the past 3 months
- Evidence or history of cirrhosis
- Women who are pregnant or breast feeding
- Other exclusion criteria apply.
Key Trial Info
Start Date :
March 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00312039
Start Date
March 31 2006
End Date
October 31 2007
Last Update
August 25 2023
Active Locations (8)
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1
Clinical Trial Site
Birmingham, Alabama, United States, 35294
2
Clinical Trial Site
Sacramento, California, United States, 95817
3
Clinical Trial Site
Miami, Florida, United States, 33136
4
Clinical Trial Site
Orlando, Florida, United States, 32803