Safety Study of Elvucitabine in HIV-1 Subjects

14-Day Randomized Double-Blind Comparative Viral Kinetic Study of Elvucitabine Versus Lamivudine Once Daily to HIv-1 Subjects With M184V

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00405249

Enrollment

Registered

2006-11-30

Start date

2006-09-30

Completion date

2006-11-30

Last updated

2009-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV-1, Treatment Experienced

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.

Interventions

DRUGelvucitabine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026