Safety Study of Elvucitabine in HIV-1 Subjects

Thomas Jefferson University

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: elvucitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00405249

ACH-443-014A

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind