Safety Study of Elvucitabine in HIV-1 S… | Clinical Trial

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elvucitabine

Drug

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Nov 30, 2006
Registry last updated: Feb 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed