Status:
COMPLETED
Safety Study of Elvucitabine in HIV-1 Subjects
Lead Sponsor:
Thomas Jefferson University
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.
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 v...
Eligibility Criteria
Inclusion
- HIV infected, clinically stable, adults
- HIVRNA 5000 -150,000, CD4 100
- Genotypically documented M184V variant
- Receiving stable ART.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2006
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00405249
Start Date
September 1 2006
End Date
November 1 2006
Last Update
February 4 2009
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107