drugset / Trial / NCT00350272
Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-naive Participants
Phase 2
Completed
76 enrolled
Alexion Pharmaceuticals, Inc.
Achillion, a wholly owned subsidiary of Alexion · collab
RandomizedParallel-groupDouble-blindTreatment
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 participant's 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 participant's response to treatment meets certain endpoints. The pharmacokinetics of elvucitabine will also be assessed during the study.
Timeline
- Start
- 2006-05
- Primary completion
- 2007-08
- Completion
- 2009-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elvucitabine | Small molecule | 10 mg | Oral |
| Comparator | Lamivudine | Other / unclassified | 300 mg | Oral |
| Background | Efavirenz | Other / unclassified | 600 mg | Oral |
| Background | Tenofovir | Small molecule | 300 mg | Oral |