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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
History of Changes
  Purpose

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


Condition Intervention Phase
HIV Infections
 Drug: elvucitabine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Thomas Jefferson University:

Estimated Enrollment: 5
Study Start Date: September 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405249

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Kathleen Squires, MD Thomas Jefferson University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00405249     History of Changes
Other Study ID Numbers: ACH-443-014A
Study First Received: November 29, 2006
Last Updated: February 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
HIV-1
Treatment Experienced

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

ClinicalTrials.gov processed this record on May 19, 2013