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Open-Label, 48 Week Extension Study of Elvucitabine in Combination With Background ART For Subjects Who Have Completed Study ACH443-014A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00380159
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : March 17, 2014
Information provided by:
Achillion Pharmaceuticals

Brief Summary:
To assess the safety of 48 weeks of treatment with 10 mg of elvucitabine in combination with background ART in subjects who completed protocol ACH443-014A and meet the inclusion and exclusion criteria.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: elvucitabine Drug: Lamivudine Drug: Emtricitabine Phase 2

Detailed Description:
This study is an open-label extension study for subjects who have completed 14 days of treatment in protocol ACH443-014A and meet all inclusion and exclusion criteria. Elvucitabine treatment (10mg) will begin on Day 1 (Day 15 following completion of protocol ACH443-014A) for all consented subjects in combination with background ART as determined by the principal investigator. Subjects will have clinical and laboratory assessments every 2 weeks for the first 8 weeks and then every 4 weeks to week 48.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label,48 Week Extension Study of Elvucitabine Administered In Combination With Background Antiretroviral Agents in Subjects Who Have Completed 14 Days of Treatment in Protocol ACH443-014A.
Study Start Date : September 2006
Primary Completion Date : December 2008
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Intervention Details:
    Drug: elvucitabine
    elvucitabine 10 mg in combination with background ART
    Drug: Lamivudine Drug: Emtricitabine

Primary Outcome Measures :
  1. To assess the safety of 48weeks of 10mg/QD of elvucitabine in combination with ART [ Time Frame: September 2008 ]

Secondary Outcome Measures :
  1. To describe the anti-viral activity of elvucitabine in combination with ART as measured by plasma HIV-1 RNA over 24 weeks [ Time Frame: September 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects who have completed 14 days of treatment in ACH443-014A and who, in the investigator's judgment, remain candidates to receive elvucitabine together with background antiretroviral therapy.

Exclusion Criteria:

  • Failure to meet inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00380159

United States, Georgia
Atlanta, Georgia, United States, 30308
United States, Ohio
ACTU University of Cincinnati
Cincinnati, Ohio, United States, 45242
Dominican Republic
Dr. Salvador B Gautier Hospital
Santo Domindo, Dominican Republic
Berlin, Germany
immunologische Ambulanz, University Clinic
Bonn, Germany
Klinikum der Universitat zu Koln
Koln, Germany
Hospital La Paz
Madrid, Spain
Sponsors and Collaborators
Achillion Pharmaceuticals
Principal Investigator: Michael Saag, MD Aids Out-Ptient Clinic University of Alabama
Principal Investigator: Richard Pollard, MD Division of ID University of CA Davis
Principal Investigator: Donna Mildvan, MD ACTU Beth Israel Medical Center
Principal Investigator: Judit Fienberg, MD University of Cincinnati
Principal Investigator: D Jayaweera, MD ID Research Unit University of Miami
Principal Investigator: Edwin DeJesus, MD Orlando Immunology Center
Principal Investigator: Melanie Thompson, MD ARCA Atlanta Georgia

Responsible Party: Achillion Pharmaceuticals, Inc., Ronald Gugliotti Identifier: NCT00380159     History of Changes
Other Study ID Numbers: ACH443-018
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: February 2014

Keywords provided by Achillion Pharmaceuticals:
Extension study to ACH443-014A

Additional relevant MeSH terms:
Anti-Retroviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents