Safety Study of Elvucitabine in HIV-1 Subjects

This study has been completed.
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00405249
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 ClinicalTrials.gov 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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00405249
ACH-443-014A
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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