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

This study has been completed.
Sponsor:
Information provided by:
Achillion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00380159
First received: September 21, 2006
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
HIV-1 Infection
Drug: elvucitabine
Drug: Lamivudine
Drug: Emtricitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Achillion Pharmaceuticals:

Primary Outcome Measures:
  • To assess the safety of 48weeks of 10mg/QD of elvucitabine in combination with ART [ Time Frame: September 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: September 2006
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: elvucitabine
    elvucitabine 10 mg in combination with background ART
    Drug: Lamivudine Drug: Emtricitabine
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380159

Locations
United States, Georgia
ARCA
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
Germany
EPIMED
Berlin, Germany
immunologische Ambulanz, University Clinic
Bonn, Germany
Klinikum der Universitat zu Koln
Koln, Germany
Spain
Hospital La Paz
Madrid, Spain
Sponsors and Collaborators
Achillion Pharmaceuticals
Investigators
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
  More Information

No publications provided

Responsible Party: Achillion Pharmaceuticals, Inc., Ronald Gugliotti
ClinicalTrials.gov Identifier: NCT00380159     History of Changes
Other Study ID Numbers: ACH443-018
Study First Received: September 21, 2006
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Emtricitabine
Anti-Retroviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 17, 2014