Safety Study of Elvucitabine in HIV-1 Subjects

This study has been completed.
Information provided by:
Thomas Jefferson University Identifier:
First received: November 29, 2006
Last updated: February 3, 2009
Last verified: February 2009

November 29, 2006
February 3, 2009
September 2006
November 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00405249 on Archive Site
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Safety Study of Elvucitabine in HIV-1 Subjects
14-Day Randomized Double-Blind Comparative Viral Kinetic Study of Elvucitabine Versus Lamivudine Once Daily to HIv-1 Subjects With M184V
The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.
This is a 14 day on treat/14 day off treatment randomized, double blind viral kinetic study of elvucitabine versus lamivudine administered once daily to HIV infected subjects with a documented M184V variant.
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: elvucitabine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2006
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infected, clinically stable, adults
  • HIVRNA 5000 -150,000, CD4 100
  • Genotypically documented M184V variant
  • Receiving stable ART.

Exclusion Criteria:

  • Hep B
  • HIV-1 genotype for 4 protease inhibitors
  • HIV-1 genotype positive for 2 NNRTI mutations
  • Previous therapy with system myelosuppressive potential within 3 months of study start
  • Use of Epogen or Neupogen
  • History of cirrhosis
  • Alcohol or drug dependence
  • Inability to tolerate oral medication
  • Women who are pregnant or breast feeding
18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
United States
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Thomas Jefferson University
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Principal Investigator: Kathleen Squires, MD Thomas Jefferson University
Thomas Jefferson University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP