This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
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
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

Resource links provided by NLM:

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.

Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information Identifier: NCT00405249     History of Changes
Other Study ID Numbers: ACH-443-014A
Study First Received: November 29, 2006
Last Updated: February 3, 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 processed this record on September 21, 2017