Safety Study of Elvucitabine in HIV-1 Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00405249
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : February 4, 2009
Information provided by:
Thomas Jefferson University

Brief Summary:
The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: elvucitabine Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 14-Day Randomized Double-Blind Comparative Viral Kinetic Study of Elvucitabine Versus Lamivudine Once Daily to HIv-1 Subjects With M184V
Study Start Date : September 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00405249

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Principal Investigator: Kathleen Squires, MD Thomas Jefferson University Identifier: NCT00405249     History of Changes
Other Study ID Numbers: ACH-443-014A
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by Thomas Jefferson University:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases