- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00405249
Safety Study of Elvucitabine in HIV-1 Subjects
February 3, 2009 updated by: Thomas Jefferson University
14-Day Randomized Double-Blind Comparative Viral Kinetic Study of Elvucitabine Versus Lamivudine Once Daily to HIv-1 Subjects With M184V
The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathleen Squires, MD, Thomas Jefferson University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
November 29, 2006
First Submitted That Met QC Criteria
November 29, 2006
First Posted (Estimate)
November 30, 2006
Study Record Updates
Last Update Posted (Estimate)
February 4, 2009
Last Update Submitted That Met QC Criteria
February 3, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Dexelvucitabine
Other Study ID Numbers
- ACH-443-014A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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