Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation

Study Identifier:
ACH443-014A
ClinicalTrials.gov Identifier:
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
Date
Mar 2006 - Oct 2007
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Sex
Female & Male
Age
18 - 65 Years

Study Details

Medical Condition
  • Human Immunodeficiency Virus
Study Drug
  • Drug: Elvucitabine
  • Drug: Lamivudine
Date
Mar 2006 - Oct 2007
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years years
Requirements Information

Protocol 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.

Trial Locations

Location
Status
Location
Clinical Trial Site
Birmingham, Alabama, United States, 35294
Status
N/A
Location
Clinical Trial Site
Sacramento, California, United States, 95817
Status
N/A
Location
Clinical Trial Site
Miami, Florida, United States, 33136
Status
N/A
Location
Clinical Trial Site
Orlando, Florida, United States, 32803
Status
N/A
Location
Clinical Trial Site
West Palm Beach, Florida, United States, 33401
Status
N/A
Location
Clinical Trial Site
Atlanta, Georgia, United States, 30308
Status
N/A