skip to content

Clinical Trials

MainTitle

Safety Study of Elvucitabine in HIV-1 Subjects

This study has been completed
Sponsor
Thomas Jefferson University


Information provided by (Responsible Party)
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

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
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

Further study details as provided by Thomas Jefferson University:

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

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
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

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 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

More Information


Responsible Party: Thomas Jefferson University  
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  

Keywords provided by Thomas Jefferson University:

HIV-1
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.