Safety Study of Elvucitabine in HIV-1 Subjects

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Dexelvucitabine

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