Safety Study of Elvucitabine in HIV-1 Subjects

This study is currently recruiting participants.

Verified by Thomas Jefferson University, May 2008

Sponsored by:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00405249

Purpose

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

Condition	Intervention	Phase
HIV Infections	Drug: elvucitabine	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Lamivudine 2',3'-Dideoxy-2',3'-didehydro-5-fluorocytidine Elvucitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	14-Day Randomized Double-Blind Comparative Viral Kinetic Study of Elvucitabine Versus Lamivudine Once Daily to HIv-1 Subjects With M184V

Further study details as provided by Thomas Jefferson University:

Estimated Enrollment:	5
Study Start Date:	September 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405249

Contacts

Contact: Gwen Verlinghieri, MSN,RN,CCRP

215-503-9060

gwen.verlinghieri@jefferson.edu

Locations

United States, Pennsylvania
Thomas Jefferson University	Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Gwen Verlinghieri, MSN, RN, CCRP 215-503-9060 gwen.verlinghieri@jefferson.edu
Principal Investigator: Kathleen Squires, MD
Sub-Investigator: Joseph Desimone, MD

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:

Kathleen Squires, MD

Thomas Jefferson University

More Information

Study ID Numbers:	ACH-443-014A
Study First Received:	November 29, 2006
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00405249
Health Authority:	United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:

HIV-1
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Lamivudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009