Safety Study of Elvucitabine in HIV-1 Subjects

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00405249
• Lead Sponsor: Thomas Jefferson University

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 variant.

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-29
• Study First Posted: 2006-11-30
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States