Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-naive Participants

Study Identifier:
ACH443-015
ClinicalTrials.gov Identifier:
NCT00350272
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Human Immunodeficiency Virus
Study Drug
  • Drug: Elvucitabine
  • Drug: Lamivudine
  • Drug: Tenofovir
  • Drug: Efavirenz
Date
May 2006 - Aug 2007
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years
Requirements Information
Sex
Female & Male
Age
18 - 60 Years

Study Details

Medical Condition
  • Human Immunodeficiency Virus
Study Drug
  • Drug: Elvucitabine
  • Drug: Lamivudine
  • Drug: Tenofovir
  • Drug: Efavirenz
Date
May 2006 - Aug 2007
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years years
Requirements Information

Protocol 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.

Trial Locations

Location
Status
Location
Clinical Trial Site
Little Rock, Arkansas, United States, 72207
Status
N/A
Location
Clinical Trial Site
Long Beach, California, United States, 90813
Status
N/A
Location
Clinical Trial Site
Los Angeles, California, United States, 90069
Status
N/A
Location
Clinical Trial Site
Washington, District of Columbia, United States, 20007
Status
N/A
Location
Clinical Trial Site
Clearwater, Florida, United States, 33765
Status
N/A
Location
Clinical Trial Site
Fort Myers, Florida, United States, 33901
Status
N/A