Safety Study of Elvucitabine in HIV-1 Subjects

NCT ID: NCT00405249

Last Updated: 2009-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2006-11-30

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

elvucitabine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Principal Investigators

Kathleen Squires, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

ACH-443-014A

Identifier Type: -

Identifier Source: org_study_id